{
    "info": {
        "nct_id": "NCT05120960",
        "official_title": "A Phase 1a/1b Study to Determine the Recommended Phase 2 Dose, of Tepotinib in Participants With MET Alterations and Brain Tumors",
        "inclusion_criteria": "In order to be eligible for participation in this trial, the participant must:\n\n1. Willing and able to provide written informed consent for the trial.\n2. 18 years of age on day of signing informed consent.\n3. Performance status of > 60 on the KPS (Karnofsky Performance Status) scale, or ECOG (Eastern Cooperative Oncology Group) performance score of 0 or 1.\n4. MRI of the brain consistent with either new or progressive brain metastasis or recurrent glioblastoma.\n5. Group A: Histologically-confirmed primary cancer or brain metastasis with MET alteration identified through molecular testing.\n6. Group B: Histiologically-confirmed WHO grade IV glioma (glioblastoma or gliosarcoma) with MET alteration identified through molecular testing.\n\n   1. Patients will be eligible if the original histology was low-grade glioma and a subsequent histiological diagnosis of grade IV glioma is made at some point along the disease trajectory.\n   2. Note: Patients with IDH wildtype grade III anaplastic astrocytoma (1p19q intact) are also elgibile, as these tumors are expected to behave similarly to grade IV glioma.\n   3. At first, second or third recurrence of glioblastoma, and patients must have received prior radiation and/or chemotherapy.\n7. Group C: NSCLC with documented activating mutation of the EGFR receptor including T790M status, and with acquired resistance on previous EGFR-TKI therapy, and MET alteration identified through molecular testing.\n\n   a. Patients must have radiological documentation of disease progression on previous EGFR-TKI therapy.\n\n   b. Patients may have received osimertinib. If brain mets progression occurs on osimertinib, patient will be eligible if continues osimertinib.\n8. Phase 1b, Group A: Patients must have NSCLC (confirmed by either histology or cytology) with documented METexon14-skipping mutations identified in primary or brain metastasis tissue and/or in circulating tumor DNA in plasma (liquid biopsy).\n9. Phase 1a, Groups A and B participants must require surgical resection for clinical care.\n\n   1. Phase 1a, Group A: Patient must be surgical candidate for brain metastasis (solitary met, single met > ~ 2 cm (surgeon's discretion), multiple mets but one large met, symptomatic met controlled on steroid, and/or highly radioresistant met), but not require immediate surgery.\n   2. Phase 1a, Group B: Patient must be surgical candidate for glioblastoma, as determined by treating physician, but not require immediate surgery.\n\n2. Phase 1a, Group C and Phase 1b, Groups A and C participants must have small, minimally symptomatic/asymptomatic brain metastasis that do not require surgical resection.\n\n3. Measurable disease\n\na. Groups A and C: Presence of at least 1 independently verified measurable brain metastasis in accordance with a modified RANO-BM (see Section 6.1.6, Tumor Imaging and Assessment of Disease) that can be accurately assessed at baseline with ≥ 5 mm* in the longest diameter with MRI, which is suitable for accurate repeated measurements and that preferably was not previously irradiated or biopsied *and must be surgical candidate b. Group B: Presence of measurable glioblastoma, per RANO criteria, and that can be accurately assessed at baseline with ≥ 5 mm* in the longest diameter with MRI, which is suitable for accurate repeated measurements *and must be surgical candidate\n\n4. Willing to undergo CSF sampling via lumbar puncture. 5. No medical contraindication to lumbar puncture (to include severe coagulopathy, radiographic concern for impending herniation or obstructive hydrocephalus, or soft tissue infection at puncture site, as outlined in MD Anderson institutional policy).\n\n1. Patient may still enroll but LP may be deferred if at any time the treating physician determines that it would be unsafe to perform this procedure due to the characteristics (size, associated edema, etc) of the brain tumor 6. If taking steroids, stable or decreasing dose of steroids for at least 5 days prior to enrollment; no more than 4 mg dexamethasone (or equivalent) total per day for patients with brain metastasis, and no more than 8 mg per day for patients with glioblastoma.\n\n   7. Demonstrate adequate organ function as defined in Table 1; all screening labs should be performed within 14 days prior to registration (see Table 1).\n\n   Table 1 Adequate Organ Function Laboratory Values System Laboratory Value Hematological Absolute neutrophil count (ANC) ≥1,500 /mcL Platelets ≥100,000 / mcL Hemoglobin ≥9 g/dL or ≥5.6 mmol/L Renal Serum creatinine OR Measured or calculated creatinine clearance (GFR can also be used in place of creatinine or CrCl) ≤1.5 X upper limit of normal (ULN) OR\n   * 60 mL/min for participant with creatinine levels > 1.5 X institutional ULN Hepatic Serum total bilirubin ≤ 1.5 X ULN OR Direct bilirubin ≤ ULN for participants with total bilirubin levels > 1.5 ULN AST (SGOT) and ALT (SGPT) ≤ 2.5 X ULN OR\n\n     * 5 X ULN for participants with liver metastases Coagulation International Normalized Ratio (INR) or Prothrombin Time (PT)\n\n   Activated Partial Thromboplastin Time (aPTT) ≤1.5 X ULN unless participant is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulants\n\n   ≤1.5 X ULN unless participant is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulants ACreatinine clearance should be calculated per institutional standard.\n\n   8. Female patients of childbearing potential should have a negative serum pregnancy test.\n\n   9. Female patients of childbearing potential should be willing to use 2 methods of birth control or be surgically sterile, or abstain from heterosexual activity, for the course of the study through 28 days after the last dose of study medication. Participants of childbearing potential are those who have not been surgically sterilized or have not been free from menses for > 1 year.\n\n   10. Male patients should agree to use an adequate method of contraception starting with the first dose of study therapy through 28 days after the last dose of study therapy.\n\n   11. For patients with brain mets, if patient had prior WBRT or SRS, progression in any measurable brain metastasis must have occurred at least 1 month after the end of radiation therapy.\n\n   12. First day of study drug must be more than 2 weeks from last day of any radiation to the brain or spinal cord/cauda equina.\n\n   13. Patients with minimally symptomatic brain metastases may be enrolled without prior radiation therapy to the brain if they do not require immediate surgical or radiation therapy in the opinion of the treating investigator and in the opinion of a radiation therapy or neurosurgical consultant.\n\n   Participant\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "1. Currently participating in or has participated in a study of an investigational agent (with the exception of participating in which the investigational agent was a 1st, 2nd, or 3rd generation EGFR-TKI) within 4 weeks prior to study enrollment.\n\n   2. Any unresolved toxicity Grade 2 or higher according to NCI-CTCAE version 5, from previous anticancer therapy, with the exception of alopecia. 3. Need for transfusion within 14 days prior to enrollment. 4. Known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or in situ cervical cancer that has undergone potentially curative therapy.\n\n   5. Active infection requiring systemic therapy. 6. History or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the participant's participation for the full duration of the trial, or is not in the best interest of the participant to participate, in the opinion of the treating investigator.\n\n   7. Known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.\n\n   8. Pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the screening visit through 28 days after the last dose of trial treatment.\n\n   9. History of ILD or interstitial pneumonitis including radiation pneumonitis that required steroid treatment.\n\n   10. Impaired cardiac function:\n\n   - Left ventricular ejection fraction < 45% defined by echocardiography\n   * Serious arrhythmia\n   * Unstable angina pectoris\n   * Congestive Heart Failure New York Heart Association III and IV\n   * Myocardial infarction, stroke, or transient ischemic attack within the last 6 months prior to study entry.\n   * Corrected QT interval (QTcF) > 470 ms for women and > 450 ms for men at screening.\n   * Any factors that increase the risk of QTc prolongation or risk of arrhythmic events such as hypokalemia, congenital long QT syndrome, family history of long QT syndrome or unexplained sudden death under 40 years of age in first degree relatives, or any concomitant medication known to prolong the QT interval and cause Torsade de Pointes.\n\n     11. Hypertension uncontrolled by standard therapies (not stabilized to < 150/90 mmHg).\n\n     12. Group C: Contraindication to the administration of osimertinib. 13. Medical history of liver fibrosis/cirrhosis. 14. Medical history of difficulty swallowing, malabsorption, or other chronic gastrointestinal disease, or conditions that may hamper compliance and/or absorption of the tested product.\n\n     15. Known human immunodeficiency virus positivity. 16. Group C: Has not received an EGFR-TKI containing treatment prior to enrollment into the study 17. Prior treatment with other agents targeting the HGF/MET pathway such as crizotinib, capmatinib, savolitinib, foretinib, glesatinib, cabozantinib, merestinib, onartuzumab, rilotumumab, emibetuzumab, and ficlatuzumab.\n\n     18. Participants currently receiving (or unable to stop use at least 1 week prior to enrollment) medications or herbal supplements known to be potent inducers of CYP3A4.",
        "miscellaneous_criteria": "Participant"
    },
    "inclusion_lines": [
        {
            "identified_line": {
                "line": "1. Willing and able to provide written informed consent for the trial.",
                "criterions": [
                    {
                        "exact_snippets": "Willing and able to provide written informed consent",
                        "criterion": "informed consent",
                        "requirement": {
                            "requirement_type": "willingness",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Willing and able to provide written informed consent",
                        "criterion": "informed consent",
                        "requirement": {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Willing and able to provide written informed consent",
                        "criterion": "informed consent",
                        "requirement": {
                            "requirement_type": "willingness",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Willing and able to provide written informed consent",
                        "criterion": "informed consent",
                        "requirement": {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "2. 18 years of age on day of signing informed consent.",
                "criterions": [
                    {
                        "exact_snippets": "18 years of age",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "18 years of age",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "3. Performance status of > 60 on the KPS (Karnofsky Performance Status) scale, or ECOG (Eastern Cooperative Oncology Group) performance score of 0 or 1.",
                "criterions": [
                    {
                        "exact_snippets": "Performance status of > 60 on the KPS (Karnofsky Performance Status) scale",
                        "criterion": "Karnofsky Performance Status",
                        "requirement": {
                            "requirement_type": "score",
                            "expected_value": {
                                "operator": ">",
                                "value": 60,
                                "unit": "KPS"
                            }
                        }
                    },
                    {
                        "exact_snippets": "ECOG (Eastern Cooperative Oncology Group) performance score of 0 or 1",
                        "criterion": "ECOG performance score",
                        "requirement": {
                            "requirement_type": "score",
                            "expected_value": [
                                "0",
                                "1"
                            ]
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Performance status of > 60 on the KPS (Karnofsky Performance Status) scale",
                                "criterion": "Karnofsky Performance Status",
                                "requirement": {
                                    "requirement_type": "score",
                                    "expected_value": {
                                        "operator": ">",
                                        "value": 60,
                                        "unit": "KPS"
                                    }
                                }
                            }
                        ]
                    },
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "ECOG (Eastern Cooperative Oncology Group) performance score of 0 or 1",
                                "criterion": "ECOG performance score",
                                "requirement": {
                                    "requirement_type": "score",
                                    "expected_value": [
                                        "0",
                                        "1"
                                    ]
                                }
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "4. MRI of the brain consistent with either new or progressive brain metastasis or recurrent glioblastoma.",
                "criterions": [
                    {
                        "exact_snippets": "MRI of the brain consistent with either new or progressive brain metastasis",
                        "criterion": "brain metastasis",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": [
                                "new",
                                "progressive"
                            ]
                        }
                    },
                    {
                        "exact_snippets": "MRI of the brain consistent with ... recurrent glioblastoma",
                        "criterion": "glioblastoma",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": "recurrent"
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "MRI of the brain consistent with either new or progressive brain metastasis",
                                "criterion": "brain metastasis",
                                "requirement": {
                                    "requirement_type": "status",
                                    "expected_value": [
                                        "new",
                                        "progressive"
                                    ]
                                }
                            }
                        ]
                    },
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "MRI of the brain consistent with ... recurrent glioblastoma",
                                "criterion": "glioblastoma",
                                "requirement": {
                                    "requirement_type": "status",
                                    "expected_value": "recurrent"
                                }
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "5. Group A: Histologically-confirmed primary cancer or brain metastasis with MET alteration identified through molecular testing.",
                "criterions": [
                    {
                        "exact_snippets": "Histologically-confirmed primary cancer",
                        "criterion": "primary cancer",
                        "requirement": {
                            "requirement_type": "confirmation",
                            "expected_value": "histologically-confirmed"
                        }
                    },
                    {
                        "exact_snippets": "brain metastasis",
                        "criterion": "brain metastasis",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "MET alteration identified through molecular testing",
                        "criterion": "MET alteration",
                        "requirement": {
                            "requirement_type": "identification method",
                            "expected_value": "molecular testing"
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Histologically-confirmed primary cancer",
                                "criterion": "primary cancer",
                                "requirement": {
                                    "requirement_type": "confirmation",
                                    "expected_value": "histologically-confirmed"
                                }
                            },
                            {
                                "exact_snippets": "MET alteration identified through molecular testing",
                                "criterion": "MET alteration",
                                "requirement": {
                                    "requirement_type": "identification method",
                                    "expected_value": "molecular testing"
                                }
                            }
                        ]
                    },
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "brain metastasis",
                                "criterion": "brain metastasis",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": true
                                }
                            },
                            {
                                "exact_snippets": "MET alteration identified through molecular testing",
                                "criterion": "MET alteration",
                                "requirement": {
                                    "requirement_type": "identification method",
                                    "expected_value": "molecular testing"
                                }
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "6. Group B: Histiologically-confirmed WHO grade IV glioma (glioblastoma or gliosarcoma) with MET alteration identified through molecular testing.",
                "criterions": [
                    {
                        "exact_snippets": "Histiologically-confirmed WHO grade IV glioma",
                        "criterion": "glioma",
                        "requirement": {
                            "requirement_type": "confirmation",
                            "expected_value": "histiologically-confirmed"
                        }
                    },
                    {
                        "exact_snippets": "Histiologically-confirmed WHO grade IV glioma",
                        "criterion": "glioma",
                        "requirement": {
                            "requirement_type": "grade",
                            "expected_value": "WHO grade IV"
                        }
                    },
                    {
                        "exact_snippets": "glioblastoma or gliosarcoma",
                        "criterion": "glioma subtype",
                        "requirement": {
                            "requirement_type": "subtype",
                            "expected_value": [
                                "glioblastoma",
                                "gliosarcoma"
                            ]
                        }
                    },
                    {
                        "exact_snippets": "MET alteration identified through molecular testing",
                        "criterion": "MET alteration",
                        "requirement": {
                            "requirement_type": "identification method",
                            "expected_value": "molecular testing"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Histiologically-confirmed WHO grade IV glioma",
                                "criterion": "glioma",
                                "requirement": {
                                    "requirement_type": "confirmation",
                                    "expected_value": "histiologically-confirmed"
                                }
                            },
                            {
                                "exact_snippets": "Histiologically-confirmed WHO grade IV glioma",
                                "criterion": "glioma",
                                "requirement": {
                                    "requirement_type": "grade",
                                    "expected_value": "WHO grade IV"
                                }
                            }
                        ]
                    },
                    {
                        "exact_snippets": "glioblastoma or gliosarcoma",
                        "criterion": "glioma subtype",
                        "requirement": {
                            "requirement_type": "subtype",
                            "expected_value": [
                                "glioblastoma",
                                "gliosarcoma"
                            ]
                        }
                    },
                    {
                        "exact_snippets": "MET alteration identified through molecular testing",
                        "criterion": "MET alteration",
                        "requirement": {
                            "requirement_type": "identification method",
                            "expected_value": "molecular testing"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "1. Patients will be eligible if the original histology was low-grade glioma and a subsequent histiological diagnosis of grade IV glioma is made at some point along the disease trajectory.",
                "criterions": [
                    {
                        "exact_snippets": "original histology was low-grade glioma",
                        "criterion": "original histology",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": "low-grade glioma"
                        }
                    },
                    {
                        "exact_snippets": "subsequent histiological diagnosis of grade IV glioma",
                        "criterion": "subsequent histological diagnosis",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": "grade IV glioma"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "original histology was low-grade glioma",
                        "criterion": "original histology",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": "low-grade glioma"
                        }
                    },
                    {
                        "exact_snippets": "subsequent histiological diagnosis of grade IV glioma",
                        "criterion": "subsequent histological diagnosis",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": "grade IV glioma"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "2. Note: Patients with IDH wildtype grade III anaplastic astrocytoma (1p19q intact) are also elgibile, as these tumors are expected to behave similarly to grade IV glioma.",
                "criterions": [
                    {
                        "exact_snippets": "IDH wildtype grade III anaplastic astrocytoma (1p19q intact)",
                        "criterion": "IDH wildtype grade III anaplastic astrocytoma",
                        "requirement": {
                            "requirement_type": "1p19q status",
                            "expected_value": "intact"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "IDH wildtype grade III anaplastic astrocytoma (1p19q intact)",
                        "criterion": "IDH wildtype grade III anaplastic astrocytoma",
                        "requirement": {
                            "requirement_type": "1p19q status",
                            "expected_value": "intact"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "3. At first, second or third recurrence of glioblastoma, and patients must have received prior radiation and/or chemotherapy.",
                "criterions": [
                    {
                        "exact_snippets": "first, second or third recurrence of glioblastoma",
                        "criterion": "recurrence of glioblastoma",
                        "requirement": {
                            "requirement_type": "recurrence count",
                            "expected_value": [
                                "first",
                                "second",
                                "third"
                            ]
                        }
                    },
                    {
                        "exact_snippets": "patients must have received prior radiation",
                        "criterion": "prior radiation",
                        "requirement": {
                            "requirement_type": "received",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "patients must have received prior ... chemotherapy",
                        "criterion": "prior chemotherapy",
                        "requirement": {
                            "requirement_type": "received",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "and_criteria": [
                            {
                                "or_criteria": [
                                    {
                                        "exact_snippets": "patients must have received prior radiation",
                                        "criterion": "prior radiation",
                                        "requirement": {
                                            "requirement_type": "received",
                                            "expected_value": true
                                        }
                                    },
                                    {
                                        "exact_snippets": "patients must have received prior ... chemotherapy",
                                        "criterion": "prior chemotherapy",
                                        "requirement": {
                                            "requirement_type": "received",
                                            "expected_value": true
                                        }
                                    }
                                ]
                            }
                        ]
                    },
                    {
                        "exact_snippets": "first, second or third recurrence of glioblastoma",
                        "criterion": "recurrence of glioblastoma",
                        "requirement": {
                            "requirement_type": "recurrence count",
                            "expected_value": [
                                "first",
                                "second",
                                "third"
                            ]
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "7. Group C: NSCLC with documented activating mutation of the EGFR receptor including T790M status, and with acquired resistance on previous EGFR-TKI therapy, and MET alteration identified through molecular testing.",
                "criterions": [
                    {
                        "exact_snippets": "NSCLC with documented activating mutation of the EGFR receptor",
                        "criterion": "EGFR receptor mutation",
                        "requirement": {
                            "requirement_type": "mutation type",
                            "expected_value": "activating"
                        }
                    },
                    {
                        "exact_snippets": "T790M status",
                        "criterion": "T790M status",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "acquired resistance on previous EGFR-TKI therapy",
                        "criterion": "acquired resistance to EGFR-TKI therapy",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "MET alteration identified through molecular testing",
                        "criterion": "MET alteration",
                        "requirement": {
                            "requirement_type": "identification method",
                            "expected_value": "molecular testing"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "NSCLC with documented activating mutation of the EGFR receptor",
                                "criterion": "EGFR receptor mutation",
                                "requirement": {
                                    "requirement_type": "mutation type",
                                    "expected_value": "activating"
                                }
                            },
                            {
                                "exact_snippets": "T790M status",
                                "criterion": "T790M status",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": true
                                }
                            }
                        ]
                    },
                    {
                        "exact_snippets": "acquired resistance on previous EGFR-TKI therapy",
                        "criterion": "acquired resistance to EGFR-TKI therapy",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "MET alteration identified through molecular testing",
                        "criterion": "MET alteration",
                        "requirement": {
                            "requirement_type": "identification method",
                            "expected_value": "molecular testing"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "a. Patients must have radiological documentation of disease progression on previous EGFR-TKI therapy.",
                "criterions": [
                    {
                        "exact_snippets": "radiological documentation of disease progression",
                        "criterion": "disease progression",
                        "requirement": {
                            "requirement_type": "documentation",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "previous EGFR-TKI therapy",
                        "criterion": "EGFR-TKI therapy",
                        "requirement": {
                            "requirement_type": "previous treatment",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "radiological documentation of disease progression",
                        "criterion": "disease progression",
                        "requirement": {
                            "requirement_type": "documentation",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "previous EGFR-TKI therapy",
                        "criterion": "EGFR-TKI therapy",
                        "requirement": {
                            "requirement_type": "previous treatment",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "b. Patients may have received osimertinib. If brain mets progression occurs on osimertinib, patient will be eligible if continues osimertinib.",
                "criterions": [
                    {
                        "exact_snippets": "Patients may have received osimertinib",
                        "criterion": "osimertinib treatment",
                        "requirement": {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "brain mets progression occurs on osimertinib",
                        "criterion": "brain metastases progression",
                        "requirement": {
                            "requirement_type": "progression",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "patient will be eligible if continues osimertinib",
                        "criterion": "continuation of osimertinib",
                        "requirement": {
                            "requirement_type": "continuation",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "condition": {
                    "and_criteria": [
                        {
                            "exact_snippets": "brain mets progression occurs on osimertinib",
                            "criterion": "brain metastases progression",
                            "requirement": {
                                "requirement_type": "progression",
                                "expected_value": true
                            }
                        },
                        {
                            "exact_snippets": "Patients may have received osimertinib",
                            "criterion": "osimertinib treatment",
                            "requirement": {
                                "requirement_type": "history",
                                "expected_value": true
                            }
                        }
                    ]
                },
                "then_criteria": {
                    "exact_snippets": "patient will be eligible if continues osimertinib",
                    "criterion": "continuation of osimertinib",
                    "requirement": {
                        "requirement_type": "continuation",
                        "expected_value": true
                    }
                },
                "else_criteria": null
            }
        },
        {
            "identified_line": {
                "line": "9. Phase 1a, Groups A and B participants must require surgical resection for clinical care.",
                "criterions": [
                    {
                        "exact_snippets": "require surgical resection for clinical care",
                        "criterion": "surgical resection",
                        "requirement": {
                            "requirement_type": "necessity",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Phase 1a",
                                "criterion": "Phase",
                                "requirement": {
                                    "requirement_type": "inclusion",
                                    "expected_value": "1a"
                                }
                            },
                            {
                                "or_criteria": [
                                    {
                                        "exact_snippets": "Groups A",
                                        "criterion": "Group",
                                        "requirement": {
                                            "requirement_type": "inclusion",
                                            "expected_value": "A"
                                        }
                                    },
                                    {
                                        "exact_snippets": "Groups B",
                                        "criterion": "Group",
                                        "requirement": {
                                            "requirement_type": "inclusion",
                                            "expected_value": "B"
                                        }
                                    }
                                ]
                            }
                        ]
                    },
                    {
                        "exact_snippets": "require surgical resection for clinical care",
                        "criterion": "surgical resection",
                        "requirement": {
                            "requirement_type": "necessity",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "1. Phase 1a, Group A: Patient must be surgical candidate for brain metastasis (solitary met, single met > ~ 2 cm (surgeon's discretion), multiple mets but one large met, symptomatic met controlled on steroid, and/or highly radioresistant met), but not require immediate surgery.",
                "criterions": [
                    {
                        "exact_snippets": "surgical candidate for brain metastasis",
                        "criterion": "surgical candidacy for brain metastasis",
                        "requirement": {
                            "requirement_type": "eligibility",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "solitary met",
                        "criterion": "solitary metastasis",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "single met > ~ 2 cm (surgeon's discretion)",
                        "criterion": "single metastasis size",
                        "requirement": {
                            "requirement_type": "size",
                            "expected_value": {
                                "operator": ">",
                                "value": 2,
                                "unit": "cm"
                            }
                        }
                    },
                    {
                        "exact_snippets": "multiple mets but one large met",
                        "criterion": "multiple metastases with one large metastasis",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "symptomatic met controlled on steroid",
                        "criterion": "symptomatic metastasis controlled on steroid",
                        "requirement": {
                            "requirement_type": "control",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "highly radioresistant met",
                        "criterion": "highly radioresistant metastasis",
                        "requirement": {
                            "requirement_type": "resistance",
                            "expected_value": "high"
                        }
                    },
                    {
                        "exact_snippets": "not require immediate surgery",
                        "criterion": "immediate surgery requirement",
                        "requirement": {
                            "requirement_type": "necessity",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "and_criteria": [
                            {
                                "and_criteria": [
                                    {
                                        "and_criteria": [
                                            {
                                                "and_criteria": [
                                                    {
                                                        "and_criteria": [
                                                            {
                                                                "exact_snippets": "surgical candidate for brain metastasis",
                                                                "criterion": "surgical candidacy for brain metastasis",
                                                                "requirement": {
                                                                    "requirement_type": "eligibility",
                                                                    "expected_value": true
                                                                }
                                                            },
                                                            {
                                                                "or_criteria": [
                                                                    {
                                                                        "exact_snippets": "solitary met",
                                                                        "criterion": "solitary metastasis",
                                                                        "requirement": {
                                                                            "requirement_type": "presence",
                                                                            "expected_value": true
                                                                        }
                                                                    },
                                                                    {
                                                                        "exact_snippets": "single met > ~ 2 cm (surgeon's discretion)",
                                                                        "criterion": "single metastasis size",
                                                                        "requirement": {
                                                                            "requirement_type": "size",
                                                                            "expected_value": {
                                                                                "operator": ">",
                                                                                "value": 2,
                                                                                "unit": "cm"
                                                                            }
                                                                        }
                                                                    },
                                                                    {
                                                                        "exact_snippets": "multiple mets but one large met",
                                                                        "criterion": "multiple metastases with one large metastasis",
                                                                        "requirement": {
                                                                            "requirement_type": "presence",
                                                                            "expected_value": true
                                                                        }
                                                                    },
                                                                    {
                                                                        "exact_snippets": "symptomatic met controlled on steroid",
                                                                        "criterion": "symptomatic metastasis controlled on steroid",
                                                                        "requirement": {
                                                                            "requirement_type": "control",
                                                                            "expected_value": true
                                                                        }
                                                                    },
                                                                    {
                                                                        "exact_snippets": "highly radioresistant met",
                                                                        "criterion": "highly radioresistant metastasis",
                                                                        "requirement": {
                                                                            "requirement_type": "resistance",
                                                                            "expected_value": "high"
                                                                        }
                                                                    }
                                                                ]
                                                            }
                                                        ]
                                                    },
                                                    {
                                                        "exact_snippets": "not require immediate surgery",
                                                        "criterion": "immediate surgery requirement",
                                                        "requirement": {
                                                            "requirement_type": "necessity",
                                                            "expected_value": false
                                                        }
                                                    }
                                                ]
                                            }
                                        ]
                                    }
                                ]
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "2. Phase 1a, Group C and Phase 1b, Groups A and C participants must have small, minimally symptomatic/asymptomatic brain metastasis that do not require surgical resection.",
                "criterions": [
                    {
                        "exact_snippets": "small, minimally symptomatic/asymptomatic brain metastasis",
                        "criterion": "brain metastasis",
                        "requirement": {
                            "requirement_type": "size",
                            "expected_value": "small"
                        }
                    },
                    {
                        "exact_snippets": "small, minimally symptomatic/asymptomatic brain metastasis",
                        "criterion": "brain metastasis",
                        "requirement": {
                            "requirement_type": "symptoms",
                            "expected_value": [
                                "minimally symptomatic",
                                "asymptomatic"
                            ]
                        }
                    },
                    {
                        "exact_snippets": "brain metastasis that do not require surgical resection",
                        "criterion": "brain metastasis",
                        "requirement": {
                            "requirement_type": "surgical resection requirement",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "or_criteria": [
                            {
                                "and_criteria": [
                                    {
                                        "exact_snippets": "small, minimally symptomatic/asymptomatic brain metastasis",
                                        "criterion": "brain metastasis",
                                        "requirement": {
                                            "requirement_type": "size",
                                            "expected_value": "small"
                                        }
                                    },
                                    {
                                        "exact_snippets": "small, minimally symptomatic/asymptomatic brain metastasis",
                                        "criterion": "brain metastasis",
                                        "requirement": {
                                            "requirement_type": "symptoms",
                                            "expected_value": [
                                                "minimally symptomatic",
                                                "asymptomatic"
                                            ]
                                        }
                                    },
                                    {
                                        "exact_snippets": "brain metastasis that do not require surgical resection",
                                        "criterion": "brain metastasis",
                                        "requirement": {
                                            "requirement_type": "surgical resection requirement",
                                            "expected_value": false
                                        }
                                    }
                                ]
                            },
                            {
                                "and_criteria": [
                                    {
                                        "exact_snippets": "small, minimally symptomatic/asymptomatic brain metastasis",
                                        "criterion": "brain metastasis",
                                        "requirement": {
                                            "requirement_type": "size",
                                            "expected_value": "small"
                                        }
                                    },
                                    {
                                        "exact_snippets": "small, minimally symptomatic/asymptomatic brain metastasis",
                                        "criterion": "brain metastasis",
                                        "requirement": {
                                            "requirement_type": "symptoms",
                                            "expected_value": [
                                                "minimally symptomatic",
                                                "asymptomatic"
                                            ]
                                        }
                                    },
                                    {
                                        "exact_snippets": "brain metastasis that do not require surgical resection",
                                        "criterion": "brain metastasis",
                                        "requirement": {
                                            "requirement_type": "surgical resection requirement",
                                            "expected_value": false
                                        }
                                    }
                                ]
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "Table 1 Adequate Organ Function Laboratory Values System Laboratory Value Hematological Absolute neutrophil count (ANC) ≥1,500 /mcL Platelets ≥100,000 / mcL Hemoglobin ≥9 g/dL or ≥5.6 mmol/L Renal Serum creatinine OR Measured or calculated creatinine clearance (GFR can also be used in place of creatinine or CrCl) ≤1.5 X upper limit of normal (ULN) OR",
                "criterions": [
                    {
                        "exact_snippets": "Absolute neutrophil count (ANC) ≥1,500 /mcL",
                        "criterion": "absolute neutrophil count (ANC)",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1500,
                                "unit": "/mcL"
                            }
                        }
                    },
                    {
                        "exact_snippets": "Platelets ≥100,000 / mcL",
                        "criterion": "platelets",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 100000,
                                "unit": "/mcL"
                            }
                        }
                    },
                    {
                        "exact_snippets": "Hemoglobin ≥9 g/dL or ≥5.6 mmol/L",
                        "criterion": "hemoglobin",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 9,
                                        "unit": "g/dL"
                                    },
                                    {
                                        "operator": ">=",
                                        "value": 5.6,
                                        "unit": "mmol/L"
                                    }
                                ]
                            }
                        }
                    },
                    {
                        "exact_snippets": "Serum creatinine OR Measured or calculated creatinine clearance ... ≤1.5 X upper limit of normal (ULN)",
                        "criterion": "serum creatinine or creatinine clearance",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "X ULN"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "and_criteria": [
                            {
                                "and_criteria": [
                                    {
                                        "exact_snippets": "Absolute neutrophil count (ANC) ≥1,500 /mcL",
                                        "criterion": "absolute neutrophil count (ANC)",
                                        "requirement": {
                                            "requirement_type": "quantity",
                                            "expected_value": {
                                                "operator": ">=",
                                                "value": 1500,
                                                "unit": "/mcL"
                                            }
                                        }
                                    },
                                    {
                                        "exact_snippets": "Platelets ≥100,000 / mcL",
                                        "criterion": "platelets",
                                        "requirement": {
                                            "requirement_type": "quantity",
                                            "expected_value": {
                                                "operator": ">=",
                                                "value": 100000,
                                                "unit": "/mcL"
                                            }
                                        }
                                    }
                                ]
                            },
                            {
                                "exact_snippets": "Hemoglobin ≥9 g/dL or ≥5.6 mmol/L",
                                "criterion": "hemoglobin",
                                "requirement": {
                                    "requirement_type": "quantity",
                                    "expected_value": {
                                        "comparisons": [
                                            {
                                                "operator": ">=",
                                                "value": 9,
                                                "unit": "g/dL"
                                            },
                                            {
                                                "operator": ">=",
                                                "value": 5.6,
                                                "unit": "mmol/L"
                                            }
                                        ]
                                    }
                                }
                            }
                        ]
                    },
                    {
                        "or_criteria": [
                            {
                                "exact_snippets": "Serum creatinine OR Measured or calculated creatinine clearance ... ≤1.5 X upper limit of normal (ULN)",
                                "criterion": "serum creatinine or creatinine clearance",
                                "requirement": {
                                    "requirement_type": "quantity",
                                    "expected_value": {
                                        "operator": "<=",
                                        "value": 1.5,
                                        "unit": "X ULN"
                                    }
                                }
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* 60 mL/min for participant with creatinine levels > 1.5 X institutional ULN Hepatic Serum total bilirubin ≤ 1.5 X ULN OR Direct bilirubin ≤ ULN for participants with total bilirubin levels > 1.5 ULN AST (SGOT) and ALT (SGPT) ≤ 2.5 X ULN OR",
                "criterions": [
                    {
                        "exact_snippets": "creatinine levels > 1.5 X institutional ULN",
                        "criterion": "creatinine levels",
                        "requirement": {
                            "requirement_type": "comparison",
                            "expected_value": {
                                "operator": ">",
                                "value": 1.5,
                                "unit": "X institutional ULN"
                            }
                        }
                    },
                    {
                        "exact_snippets": "Hepatic Serum total bilirubin ≤ 1.5 X ULN",
                        "criterion": "Hepatic Serum total bilirubin",
                        "requirement": {
                            "requirement_type": "comparison",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "X ULN"
                            }
                        }
                    },
                    {
                        "exact_snippets": "Direct bilirubin ≤ ULN for participants with total bilirubin levels > 1.5 ULN",
                        "criterion": "Direct bilirubin",
                        "requirement": {
                            "requirement_type": "comparison",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1,
                                "unit": "ULN"
                            }
                        }
                    },
                    {
                        "exact_snippets": "AST (SGOT) and ALT (SGPT) ≤ 2.5 X ULN",
                        "criterion": "AST (SGOT) and ALT (SGPT)",
                        "requirement": {
                            "requirement_type": "comparison",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2.5,
                                "unit": "X ULN"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "condition": {
                            "and_criteria": [
                                {
                                    "exact_snippets": "creatinine levels > 1.5 X institutional ULN",
                                    "criterion": "creatinine levels",
                                    "requirement": {
                                        "requirement_type": "comparison",
                                        "expected_value": {
                                            "operator": ">",
                                            "value": 1.5,
                                            "unit": "X institutional ULN"
                                        }
                                    }
                                },
                                {
                                    "exact_snippets": "* 60 mL/min for participant with creatinine levels > 1.5 X institutional ULN",
                                    "criterion": "creatinine clearance",
                                    "requirement": {
                                        "requirement_type": "comparison",
                                        "expected_value": {
                                            "operator": ">=",
                                            "value": 60,
                                            "unit": "mL/min"
                                        }
                                    }
                                }
                            ]
                        },
                        "then_criteria": null,
                        "else_criteria": null
                    },
                    {
                        "or_criteria": [
                            {
                                "exact_snippets": "Hepatic Serum total bilirubin ≤ 1.5 X ULN",
                                "criterion": "Hepatic Serum total bilirubin",
                                "requirement": {
                                    "requirement_type": "comparison",
                                    "expected_value": {
                                        "operator": "<=",
                                        "value": 1.5,
                                        "unit": "X ULN"
                                    }
                                }
                            },
                            {
                                "condition": {
                                    "exact_snippets": "Direct bilirubin ≤ ULN for participants with total bilirubin levels > 1.5 ULN",
                                    "criterion": "total bilirubin levels",
                                    "requirement": {
                                        "requirement_type": "comparison",
                                        "expected_value": {
                                            "operator": ">",
                                            "value": 1.5,
                                            "unit": "ULN"
                                        }
                                    }
                                },
                                "then_criteria": {
                                    "exact_snippets": "Direct bilirubin ≤ ULN for participants with total bilirubin levels > 1.5 ULN",
                                    "criterion": "Direct bilirubin",
                                    "requirement": {
                                        "requirement_type": "comparison",
                                        "expected_value": {
                                            "operator": "<=",
                                            "value": 1,
                                            "unit": "ULN"
                                        }
                                    }
                                },
                                "else_criteria": null
                            }
                        ]
                    },
                    {
                        "exact_snippets": "AST (SGOT) and ALT (SGPT) ≤ 2.5 X ULN",
                        "criterion": "AST (SGOT) and ALT (SGPT)",
                        "requirement": {
                            "requirement_type": "comparison",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2.5,
                                "unit": "X ULN"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* 5 X ULN for participants with liver metastases Coagulation International Normalized Ratio (INR) or Prothrombin Time (PT)",
                "criterions": [
                    {
                        "exact_snippets": "5 X ULN for participants with liver metastases",
                        "criterion": "liver metastases",
                        "requirement": {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": "=",
                                "value": 5,
                                "unit": "X ULN"
                            }
                        }
                    },
                    {
                        "exact_snippets": "Coagulation International Normalized Ratio (INR)",
                        "criterion": "Coagulation International Normalized Ratio (INR)",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Prothrombin Time (PT)",
                        "criterion": "Prothrombin Time (PT)",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "condition": {
                            "exact_snippets": "5 X ULN for participants with liver metastases",
                            "criterion": "liver metastases",
                            "requirement": {
                                "requirement_type": "severity",
                                "expected_value": {
                                    "operator": "=",
                                    "value": 5,
                                    "unit": "X ULN"
                                }
                            }
                        },
                        "then_criteria": {
                            "or_criteria": [
                                {
                                    "exact_snippets": "Coagulation International Normalized Ratio (INR)",
                                    "criterion": "Coagulation International Normalized Ratio (INR)",
                                    "requirement": {
                                        "requirement_type": "presence",
                                        "expected_value": true
                                    }
                                },
                                {
                                    "exact_snippets": "Prothrombin Time (PT)",
                                    "criterion": "Prothrombin Time (PT)",
                                    "requirement": {
                                        "requirement_type": "presence",
                                        "expected_value": true
                                    }
                                }
                            ]
                        },
                        "else_criteria": null
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "Activated Partial Thromboplastin Time (aPTT) ≤1.5 X ULN unless participant is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulants",
                "criterions": [
                    {
                        "exact_snippets": "Activated Partial Thromboplastin Time (aPTT) ≤1.5 X ULN",
                        "criterion": "Activated Partial Thromboplastin Time (aPTT)",
                        "requirement": {
                            "requirement_type": "comparison",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "X ULN"
                            }
                        }
                    },
                    {
                        "exact_snippets": "unless participant is receiving anticoagulant therapy",
                        "criterion": "anticoagulant therapy",
                        "requirement": {
                            "requirement_type": "receiving",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "PT or PTT is within therapeutic range of intended use of anticoagulants",
                        "criterion": "PT or PTT",
                        "requirement": {
                            "requirement_type": "range",
                            "expected_value": "therapeutic range of intended use of anticoagulants"
                        }
                    }
                ]
            },
            "logical_structure": {
                "condition": {
                    "and_criteria": [
                        {
                            "exact_snippets": "unless participant is receiving anticoagulant therapy",
                            "criterion": "anticoagulant therapy",
                            "requirement": {
                                "requirement_type": "receiving",
                                "expected_value": true
                            }
                        }
                    ]
                },
                "then_criteria": {
                    "and_criteria": [
                        {
                            "exact_snippets": "PT or PTT is within therapeutic range of intended use of anticoagulants",
                            "criterion": "PT or PTT",
                            "requirement": {
                                "requirement_type": "range",
                                "expected_value": "therapeutic range of intended use of anticoagulants"
                            }
                        }
                    ]
                },
                "else_criteria": {
                    "and_criteria": [
                        {
                            "exact_snippets": "Activated Partial Thromboplastin Time (aPTT) ≤1.5 X ULN",
                            "criterion": "Activated Partial Thromboplastin Time (aPTT)",
                            "requirement": {
                                "requirement_type": "comparison",
                                "expected_value": {
                                    "operator": "<=",
                                    "value": 1.5,
                                    "unit": "X ULN"
                                }
                            }
                        }
                    ]
                }
            }
        },
        {
            "identified_line": {
                "line": "≤1.5 X ULN unless participant is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulants ACreatinine clearance should be calculated per institutional standard.",
                "criterions": [
                    {
                        "exact_snippets": "≤1.5 X ULN unless participant is receiving anticoagulant therapy",
                        "criterion": "PT or PTT",
                        "requirement": {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "X ULN"
                            }
                        }
                    },
                    {
                        "exact_snippets": "≤1.5 X ULN unless participant is receiving anticoagulant therapy",
                        "criterion": "PT or PTT",
                        "requirement": {
                            "requirement_type": "condition",
                            "expected_value": "unless participant is receiving anticoagulant therapy"
                        }
                    },
                    {
                        "exact_snippets": "PT or PTT is within therapeutic range of intended use of anticoagulants",
                        "criterion": "PT or PTT",
                        "requirement": {
                            "requirement_type": "range",
                            "expected_value": "within therapeutic range of intended use of anticoagulants"
                        }
                    },
                    {
                        "exact_snippets": "Creatinine clearance should be calculated per institutional standard",
                        "criterion": "creatinine clearance",
                        "requirement": {
                            "requirement_type": "calculation method",
                            "expected_value": "per institutional standard"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "condition": {
                            "and_criteria": [
                                {
                                    "exact_snippets": "≤1.5 X ULN unless participant is receiving anticoagulant therapy",
                                    "criterion": "PT or PTT",
                                    "requirement": {
                                        "requirement_type": "level",
                                        "expected_value": {
                                            "operator": "<=",
                                            "value": 1.5,
                                            "unit": "X ULN"
                                        }
                                    }
                                },
                                {
                                    "exact_snippets": "≤1.5 X ULN unless participant is receiving anticoagulant therapy",
                                    "criterion": "PT or PTT",
                                    "requirement": {
                                        "requirement_type": "condition",
                                        "expected_value": "unless participant is receiving anticoagulant therapy"
                                    }
                                }
                            ]
                        },
                        "then_criteria": {
                            "exact_snippets": "PT or PTT is within therapeutic range of intended use of anticoagulants",
                            "criterion": "PT or PTT",
                            "requirement": {
                                "requirement_type": "range",
                                "expected_value": "within therapeutic range of intended use of anticoagulants"
                            }
                        },
                        "else_criteria": null
                    },
                    {
                        "exact_snippets": "Creatinine clearance should be calculated per institutional standard",
                        "criterion": "creatinine clearance",
                        "requirement": {
                            "requirement_type": "calculation method",
                            "expected_value": "per institutional standard"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "8. Female patients of childbearing potential should have a negative serum pregnancy test.",
                "criterions": [
                    {
                        "exact_snippets": "Female patients of childbearing potential",
                        "criterion": "gender and reproductive status",
                        "requirement": {
                            "requirement_type": "gender",
                            "expected_value": "female"
                        }
                    },
                    {
                        "exact_snippets": "Female patients of childbearing potential",
                        "criterion": "gender and reproductive status",
                        "requirement": {
                            "requirement_type": "reproductive status",
                            "expected_value": "childbearing potential"
                        }
                    },
                    {
                        "exact_snippets": "negative serum pregnancy test",
                        "criterion": "serum pregnancy test",
                        "requirement": {
                            "requirement_type": "result",
                            "expected_value": "negative"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Female patients of childbearing potential",
                                "criterion": "gender and reproductive status",
                                "requirement": {
                                    "requirement_type": "gender",
                                    "expected_value": "female"
                                }
                            },
                            {
                                "exact_snippets": "Female patients of childbearing potential",
                                "criterion": "gender and reproductive status",
                                "requirement": {
                                    "requirement_type": "reproductive status",
                                    "expected_value": "childbearing potential"
                                }
                            }
                        ]
                    },
                    {
                        "exact_snippets": "negative serum pregnancy test",
                        "criterion": "serum pregnancy test",
                        "requirement": {
                            "requirement_type": "result",
                            "expected_value": "negative"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "10. Male patients should agree to use an adequate method of contraception starting with the first dose of study therapy through 28 days after the last dose of study therapy.",
                "criterions": [
                    {
                        "exact_snippets": "Male patients",
                        "criterion": "gender",
                        "requirement": {
                            "requirement_type": "expected gender",
                            "expected_value": "male"
                        }
                    },
                    {
                        "exact_snippets": "agree to use an adequate method of contraception",
                        "criterion": "contraception use",
                        "requirement": {
                            "requirement_type": "agreement",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "starting with the first dose of study therapy through 28 days after the last dose of study therapy",
                        "criterion": "contraception use duration",
                        "requirement": {
                            "requirement_type": "duration",
                            "expected_value": "starting with the first dose of study therapy through 28 days after the last dose of study therapy"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Male patients",
                                "criterion": "gender",
                                "requirement": {
                                    "requirement_type": "expected gender",
                                    "expected_value": "male"
                                }
                            },
                            {
                                "exact_snippets": "agree to use an adequate method of contraception",
                                "criterion": "contraception use",
                                "requirement": {
                                    "requirement_type": "agreement",
                                    "expected_value": true
                                }
                            }
                        ]
                    },
                    {
                        "exact_snippets": "starting with the first dose of study therapy through 28 days after the last dose of study therapy",
                        "criterion": "contraception use duration",
                        "requirement": {
                            "requirement_type": "duration",
                            "expected_value": "starting with the first dose of study therapy through 28 days after the last dose of study therapy"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "11. For patients with brain mets, if patient had prior WBRT or SRS, progression in any measurable brain metastasis must have occurred at least 1 month after the end of radiation therapy.",
                "criterions": [
                    {
                        "exact_snippets": "patients with brain mets",
                        "criterion": "brain metastases",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "prior WBRT or SRS",
                        "criterion": "prior radiation therapy",
                        "requirement": {
                            "requirement_type": "type",
                            "expected_value": [
                                "WBRT",
                                "SRS"
                            ]
                        }
                    },
                    {
                        "exact_snippets": "progression in any measurable brain metastasis must have occurred at least 1 month after the end of radiation therapy",
                        "criterion": "progression of brain metastasis",
                        "requirement": {
                            "requirement_type": "time since radiation therapy",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1,
                                "unit": "month"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "condition": {
                    "and_criteria": [
                        {
                            "exact_snippets": "patients with brain mets",
                            "criterion": "brain metastases",
                            "requirement": {
                                "requirement_type": "presence",
                                "expected_value": true
                            }
                        },
                        {
                            "exact_snippets": "prior WBRT or SRS",
                            "criterion": "prior radiation therapy",
                            "requirement": {
                                "requirement_type": "type",
                                "expected_value": [
                                    "WBRT",
                                    "SRS"
                                ]
                            }
                        }
                    ]
                },
                "then_criteria": {
                    "exact_snippets": "progression in any measurable brain metastasis must have occurred at least 1 month after the end of radiation therapy",
                    "criterion": "progression of brain metastasis",
                    "requirement": {
                        "requirement_type": "time since radiation therapy",
                        "expected_value": {
                            "operator": ">=",
                            "value": 1,
                            "unit": "month"
                        }
                    }
                },
                "else_criteria": null
            }
        },
        {
            "identified_line": {
                "line": "12. First day of study drug must be more than 2 weeks from last day of any radiation to the brain or spinal cord/cauda equina.",
                "criterions": [
                    {
                        "exact_snippets": "First day of study drug must be more than 2 weeks from last day of any radiation to the brain or spinal cord/cauda equina.",
                        "criterion": "time since last radiation to brain or spinal cord/cauda equina",
                        "requirement": {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">",
                                "value": 2,
                                "unit": "weeks"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "First day of study drug must be more than 2 weeks from last day of any radiation to the brain or spinal cord/cauda equina.",
                        "criterion": "time since last radiation to brain or spinal cord/cauda equina",
                        "requirement": {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">",
                                "value": 2,
                                "unit": "weeks"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "13. Patients with minimally symptomatic brain metastases may be enrolled without prior radiation therapy to the brain if they do not require immediate surgical or radiation therapy in the opinion of the treating investigator and in the opinion of a radiation therapy or neurosurgical consultant.",
                "criterions": [
                    {
                        "exact_snippets": "minimally symptomatic brain metastases",
                        "criterion": "brain metastases",
                        "requirement": {
                            "requirement_type": "symptom severity",
                            "expected_value": "minimally symptomatic"
                        }
                    },
                    {
                        "exact_snippets": "without prior radiation therapy to the brain",
                        "criterion": "prior radiation therapy to the brain",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "do not require immediate surgical or radiation therapy",
                        "criterion": "immediate surgical or radiation therapy requirement",
                        "requirement": {
                            "requirement_type": "necessity",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "in the opinion of the treating investigator",
                        "criterion": "treating investigator's opinion",
                        "requirement": {
                            "requirement_type": "agreement",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "in the opinion of a radiation therapy or neurosurgical consultant",
                        "criterion": "radiation therapy or neurosurgical consultant's opinion",
                        "requirement": {
                            "requirement_type": "agreement",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "and_criteria": [
                            {
                                "and_criteria": [
                                    {
                                        "and_criteria": [
                                            {
                                                "exact_snippets": "minimally symptomatic brain metastases",
                                                "criterion": "brain metastases",
                                                "requirement": {
                                                    "requirement_type": "symptom severity",
                                                    "expected_value": "minimally symptomatic"
                                                }
                                            },
                                            {
                                                "exact_snippets": "without prior radiation therapy to the brain",
                                                "criterion": "prior radiation therapy to the brain",
                                                "requirement": {
                                                    "requirement_type": "presence",
                                                    "expected_value": false
                                                }
                                            }
                                        ]
                                    },
                                    {
                                        "exact_snippets": "do not require immediate surgical or radiation therapy",
                                        "criterion": "immediate surgical or radiation therapy requirement",
                                        "requirement": {
                                            "requirement_type": "necessity",
                                            "expected_value": false
                                        }
                                    }
                                ]
                            },
                            {
                                "exact_snippets": "in the opinion of the treating investigator",
                                "criterion": "treating investigator's opinion",
                                "requirement": {
                                    "requirement_type": "agreement",
                                    "expected_value": true
                                }
                            }
                        ]
                    },
                    {
                        "exact_snippets": "in the opinion of a radiation therapy or neurosurgical consultant",
                        "criterion": "radiation therapy or neurosurgical consultant's opinion",
                        "requirement": {
                            "requirement_type": "agreement",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "Healthy volunteers allowed",
                "criterions": [
                    {
                        "exact_snippets": "Healthy volunteers allowed",
                        "criterion": "volunteer health status",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": "healthy"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Healthy volunteers allowed",
                        "criterion": "volunteer health status",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": "healthy"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "Must have minimum age of 18 Years",
                "criterions": [
                    {
                        "exact_snippets": "minimum age of 18 Years",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "Years"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "minimum age of 18 Years",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "Years"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "In order to be eligible for participation in this trial, the participant must:",
                "criterions": []
            },
            "logical_structure": {
                "and_criteria": []
            }
        },
        {
            "identified_line": {
                "line": "Participant",
                "criterions": []
            },
            "logical_structure": {
                "and_criteria": []
            }
        }
    ],
    "exclusion_lines": [
        {
            "identified_line": {
                "line": "2. Any unresolved toxicity Grade 2 or higher according to NCI-CTCAE version 5, from previous anticancer therapy, with the exception of alopecia. 3. Need for transfusion within 14 days prior to enrollment. 4. Known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or in situ cervical cancer that has undergone potentially curative therapy.",
                "criterions": [
                    {
                        "exact_snippets": "unresolved toxicity Grade 2 or higher according to NCI-CTCAE version 5, from previous anticancer therapy",
                        "criterion": "unresolved toxicity",
                        "requirement": {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2,
                                "unit": "Grade"
                            }
                        }
                    },
                    {
                        "exact_snippets": "Need for transfusion within 14 days prior to enrollment",
                        "criterion": "need for transfusion",
                        "requirement": {
                            "requirement_type": "time frame",
                            "expected_value": "within 14 days prior to enrollment"
                        }
                    },
                    {
                        "exact_snippets": "Known additional malignancy that is progressing or requires active treatment",
                        "criterion": "additional malignancy",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": [
                                "progressing",
                                "requires active treatment"
                            ]
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "and_criteria": [
                            {
                                "not_criteria": {
                                    "and_criteria": [
                                        {
                                            "exact_snippets": "unresolved toxicity Grade 2 or higher according to NCI-CTCAE version 5, from previous anticancer therapy",
                                            "criterion": "unresolved toxicity",
                                            "requirement": {
                                                "requirement_type": "severity",
                                                "expected_value": {
                                                    "operator": ">=",
                                                    "value": 2,
                                                    "unit": "Grade"
                                                }
                                            }
                                        },
                                        {
                                            "not_criteria": {
                                                "exact_snippets": "unresolved toxicity Grade 2 or higher according to NCI-CTCAE version 5, from previous anticancer therapy",
                                                "criterion": "unresolved toxicity",
                                                "requirement": {
                                                    "requirement_type": "presence",
                                                    "expected_value": "alopecia"
                                                }
                                            }
                                        }
                                    ]
                                }
                            },
                            {
                                "exact_snippets": "Need for transfusion within 14 days prior to enrollment",
                                "criterion": "need for transfusion",
                                "requirement": {
                                    "requirement_type": "time frame",
                                    "expected_value": "within 14 days prior to enrollment"
                                }
                            }
                        ]
                    },
                    {
                        "not_criteria": {
                            "and_criteria": [
                                {
                                    "exact_snippets": "Known additional malignancy that is progressing or requires active treatment",
                                    "criterion": "additional malignancy",
                                    "requirement": {
                                        "requirement_type": "status",
                                        "expected_value": [
                                            "progressing",
                                            "requires active treatment"
                                        ]
                                    }
                                },
                                {
                                    "not_criteria": {
                                        "or_criteria": [
                                            {
                                                "exact_snippets": "Known additional malignancy that is progressing or requires active treatment",
                                                "criterion": "additional malignancy",
                                                "requirement": {
                                                    "requirement_type": "type",
                                                    "expected_value": "basal cell carcinoma of the skin"
                                                }
                                            },
                                            {
                                                "exact_snippets": "Known additional malignancy that is progressing or requires active treatment",
                                                "criterion": "additional malignancy",
                                                "requirement": {
                                                    "requirement_type": "type",
                                                    "expected_value": "squamous cell carcinoma of the skin"
                                                }
                                            },
                                            {
                                                "exact_snippets": "Known additional malignancy that is progressing or requires active treatment",
                                                "criterion": "additional malignancy",
                                                "requirement": {
                                                    "requirement_type": "type",
                                                    "expected_value": "in situ cervical cancer"
                                                }
                                            }
                                        ]
                                    }
                                }
                            ]
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "5. Active infection requiring systemic therapy. 6. History or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the participant's participation for the full duration of the trial, or is not in the best interest of the participant to participate, in the opinion of the treating investigator.",
                "criterions": [
                    {
                        "exact_snippets": "Active infection requiring systemic therapy",
                        "criterion": "active infection",
                        "requirement": {
                            "requirement_type": "treatment",
                            "expected_value": "systemic therapy"
                        }
                    },
                    {
                        "exact_snippets": "History or current evidence of any condition, therapy, or laboratory abnormality",
                        "criterion": "condition, therapy, or laboratory abnormality",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Active infection requiring systemic therapy",
                                "criterion": "active infection",
                                "requirement": {
                                    "requirement_type": "treatment",
                                    "expected_value": "systemic therapy"
                                }
                            },
                            {
                                "exact_snippets": "History or current evidence of any condition, therapy, or laboratory abnormality",
                                "criterion": "condition, therapy, or laboratory abnormality",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": true
                                }
                            }
                        ]
                    },
                    {
                        "exact_snippets": "History or current evidence of any condition, therapy, or laboratory abnormality",
                        "criterion": "condition, therapy, or laboratory abnormality",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "7. Known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.",
                "criterions": [
                    {
                        "exact_snippets": "Known psychiatric ... interfere with cooperation with the requirements of the trial.",
                        "criterion": "psychiatric disorders",
                        "requirement": {
                            "requirement_type": "interference with trial cooperation",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "substance abuse disorders ... interfere with cooperation with the requirements of the trial.",
                        "criterion": "substance abuse disorders",
                        "requirement": {
                            "requirement_type": "interference with trial cooperation",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "exact_snippets": "Known psychiatric ... interfere with cooperation with the requirements of the trial.",
                        "criterion": "psychiatric disorders",
                        "requirement": {
                            "requirement_type": "interference with trial cooperation",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "substance abuse disorders ... interfere with cooperation with the requirements of the trial.",
                        "criterion": "substance abuse disorders",
                        "requirement": {
                            "requirement_type": "interference with trial cooperation",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "8. Pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the screening visit through 28 days after the last dose of trial treatment.",
                "criterions": [
                    {
                        "exact_snippets": "Pregnant",
                        "criterion": "pregnancy status",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "breastfeeding",
                        "criterion": "breastfeeding status",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "expecting to conceive",
                        "criterion": "expecting to conceive",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "father children",
                        "criterion": "expecting to father children",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Pregnant",
                                "criterion": "pregnancy status",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": false
                                }
                            },
                            {
                                "exact_snippets": "breastfeeding",
                                "criterion": "breastfeeding status",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": false
                                }
                            }
                        ]
                    },
                    {
                        "exact_snippets": "expecting to conceive",
                        "criterion": "expecting to conceive",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "father children",
                        "criterion": "expecting to father children",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "9. History of ILD or interstitial pneumonitis including radiation pneumonitis that required steroid treatment.",
                "criterions": [
                    {
                        "exact_snippets": "History of ILD",
                        "criterion": "interstitial lung disease (ILD)",
                        "requirement": {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "interstitial pneumonitis",
                        "criterion": "interstitial pneumonitis",
                        "requirement": {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "radiation pneumonitis that required steroid treatment",
                        "criterion": "radiation pneumonitis",
                        "requirement": {
                            "requirement_type": "treatment requirement",
                            "expected_value": "steroid treatment"
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "History of ILD",
                                "criterion": "interstitial lung disease (ILD)",
                                "requirement": {
                                    "requirement_type": "history",
                                    "expected_value": true
                                }
                            },
                            {
                                "exact_snippets": "interstitial pneumonitis",
                                "criterion": "interstitial pneumonitis",
                                "requirement": {
                                    "requirement_type": "history",
                                    "expected_value": true
                                }
                            }
                        ]
                    },
                    {
                        "exact_snippets": "radiation pneumonitis that required steroid treatment",
                        "criterion": "radiation pneumonitis",
                        "requirement": {
                            "requirement_type": "treatment requirement",
                            "expected_value": "steroid treatment"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "10. Impaired cardiac function:",
                "criterions": [
                    {
                        "exact_snippets": "Impaired cardiac function",
                        "criterion": "cardiac function",
                        "requirement": {
                            "requirement_type": "impairment",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "not_criteria": {
                    "exact_snippets": "Impaired cardiac function",
                    "criterion": "cardiac function",
                    "requirement": {
                        "requirement_type": "impairment",
                        "expected_value": true
                    }
                }
            }
        },
        {
            "identified_line": {
                "line": "- Left ventricular ejection fraction < 45% defined by echocardiography",
                "criterions": [
                    {
                        "exact_snippets": "Left ventricular ejection fraction < 45%",
                        "criterion": "left ventricular ejection fraction",
                        "requirement": {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": "<",
                                "value": 45,
                                "unit": "%"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Left ventricular ejection fraction < 45%",
                        "criterion": "left ventricular ejection fraction",
                        "requirement": {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": "<",
                                "value": 45,
                                "unit": "%"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "12. Group C: Contraindication to the administration of osimertinib. 13. Medical history of liver fibrosis/cirrhosis. 14. Medical history of difficulty swallowing, malabsorption, or other chronic gastrointestinal disease, or conditions that may hamper compliance and/or absorption of the tested product.",
                "criterions": [
                    {
                        "exact_snippets": "Contraindication to the administration of osimertinib",
                        "criterion": "contraindication to osimertinib",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Medical history of liver fibrosis/cirrhosis",
                        "criterion": "liver fibrosis/cirrhosis",
                        "requirement": {
                            "requirement_type": "medical history",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Medical history of difficulty swallowing",
                        "criterion": "difficulty swallowing",
                        "requirement": {
                            "requirement_type": "medical history",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Medical history of ... malabsorption",
                        "criterion": "malabsorption",
                        "requirement": {
                            "requirement_type": "medical history",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Medical history of ... other chronic gastrointestinal disease",
                        "criterion": "chronic gastrointestinal disease",
                        "requirement": {
                            "requirement_type": "medical history",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "conditions that may hamper compliance and/or absorption of the tested product",
                        "criterion": "conditions hampering compliance/absorption",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "and_criteria": [
                            {
                                "and_criteria": [
                                    {
                                        "and_criteria": [
                                            {
                                                "and_criteria": [
                                                    {
                                                        "and_criteria": [
                                                            {
                                                                "exact_snippets": "Contraindication to the administration of osimertinib",
                                                                "criterion": "contraindication to osimertinib",
                                                                "requirement": {
                                                                    "requirement_type": "presence",
                                                                    "expected_value": true
                                                                }
                                                            },
                                                            {
                                                                "exact_snippets": "Medical history of liver fibrosis/cirrhosis",
                                                                "criterion": "liver fibrosis/cirrhosis",
                                                                "requirement": {
                                                                    "requirement_type": "medical history",
                                                                    "expected_value": true
                                                                }
                                                            }
                                                        ]
                                                    },
                                                    {
                                                        "exact_snippets": "Medical history of difficulty swallowing",
                                                        "criterion": "difficulty swallowing",
                                                        "requirement": {
                                                            "requirement_type": "medical history",
                                                            "expected_value": true
                                                        }
                                                    }
                                                ]
                                            },
                                            {
                                                "exact_snippets": "Medical history of ... malabsorption",
                                                "criterion": "malabsorption",
                                                "requirement": {
                                                    "requirement_type": "medical history",
                                                    "expected_value": true
                                                }
                                            }
                                        ]
                                    },
                                    {
                                        "exact_snippets": "Medical history of ... other chronic gastrointestinal disease",
                                        "criterion": "chronic gastrointestinal disease",
                                        "requirement": {
                                            "requirement_type": "medical history",
                                            "expected_value": true
                                        }
                                    }
                                ]
                            },
                            {
                                "exact_snippets": "conditions that may hamper compliance and/or absorption of the tested product",
                                "criterion": "conditions hampering compliance/absorption",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": true
                                }
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "15. Known human immunodeficiency virus positivity. 16. Group C: Has not received an EGFR-TKI containing treatment prior to enrollment into the study 17. Prior treatment with other agents targeting the HGF/MET pathway such as crizotinib, capmatinib, savolitinib, foretinib, glesatinib, cabozantinib, merestinib, onartuzumab, rilotumumab, emibetuzumab, and ficlatuzumab.",
                "criterions": [
                    {
                        "exact_snippets": "Known human immunodeficiency virus positivity",
                        "criterion": "human immunodeficiency virus",
                        "requirement": {
                            "requirement_type": "positivity",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Group C: Has not received an EGFR-TKI containing treatment prior to enrollment into the study",
                        "criterion": "EGFR-TKI containing treatment",
                        "requirement": {
                            "requirement_type": "prior receipt",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "Prior treatment with other agents targeting the HGF/MET pathway such as crizotinib, capmatinib, savolitinib, foretinib, glesatinib, cabozantinib, merestinib, onartuzumab, rilotumumab, emibetuzumab, and ficlatuzumab",
                        "criterion": "agents targeting the HGF/MET pathway",
                        "requirement": {
                            "requirement_type": "prior treatment",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Group C: Has not received an EGFR-TKI containing treatment prior to enrollment into the study",
                                "criterion": "EGFR-TKI containing treatment",
                                "requirement": {
                                    "requirement_type": "prior receipt",
                                    "expected_value": false
                                }
                            },
                            {
                                "exact_snippets": "Prior treatment with other agents targeting the HGF/MET pathway such as crizotinib, capmatinib, savolitinib, foretinib, glesatinib, cabozantinib, merestinib, onartuzumab, rilotumumab, emibetuzumab, and ficlatuzumab",
                                "criterion": "agents targeting the HGF/MET pathway",
                                "requirement": {
                                    "requirement_type": "prior treatment",
                                    "expected_value": true
                                }
                            }
                        ]
                    },
                    {
                        "exact_snippets": "Known human immunodeficiency virus positivity",
                        "criterion": "human immunodeficiency virus",
                        "requirement": {
                            "requirement_type": "positivity",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Corrected QT interval (QTcF) > 470 ms for women and > 450 ms for men at screening.",
                "criterions": [
                    {
                        "exact_snippets": "Corrected QT interval (QTcF) > 470 ms for women",
                        "criterion": "Corrected QT interval (QTcF)",
                        "requirement": {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">",
                                "value": 470,
                                "unit": "ms"
                            }
                        }
                    },
                    {
                        "exact_snippets": "Corrected QT interval (QTcF) > 450 ms for men",
                        "criterion": "Corrected QT interval (QTcF)",
                        "requirement": {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">",
                                "value": 450,
                                "unit": "ms"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Corrected QT interval (QTcF) > 470 ms for women",
                                "criterion": "Corrected QT interval (QTcF)",
                                "requirement": {
                                    "requirement_type": "value",
                                    "expected_value": {
                                        "operator": ">",
                                        "value": 470,
                                        "unit": "ms"
                                    }
                                }
                            },
                            {
                                "exact_snippets": "Corrected QT interval (QTcF) > 470 ms for women",
                                "criterion": "gender",
                                "requirement": {
                                    "requirement_type": "value",
                                    "expected_value": "female"
                                }
                            }
                        ]
                    },
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Corrected QT interval (QTcF) > 450 ms for men",
                                "criterion": "Corrected QT interval (QTcF)",
                                "requirement": {
                                    "requirement_type": "value",
                                    "expected_value": {
                                        "operator": ">",
                                        "value": 450,
                                        "unit": "ms"
                                    }
                                }
                            },
                            {
                                "exact_snippets": "Corrected QT interval (QTcF) > 450 ms for men",
                                "criterion": "gender",
                                "requirement": {
                                    "requirement_type": "value",
                                    "expected_value": "male"
                                }
                            }
                        ]
                    }
                ]
            }
        }
    ],
    "miscellaneous_lines": [
        {
            "identified_line": {
                "line": "Participant",
                "criterions": []
            },
            "logical_structure": {
                "and_criteria": []
            }
        }
    ],
    "failed_inclusion": [
        {
            "identified_line": {
                "line": "8. Phase 1b, Group A: Patients must have NSCLC (confirmed by either histology or cytology) with documented METexon14-skipping mutations identified in primary or brain metastasis tissue and/or in circulating tumor DNA in plasma (liquid biopsy).",
                "criterions": [
                    {
                        "exact_snippets": "NSCLC (confirmed by either histology or cytology)",
                        "criterion": "NSCLC",
                        "requirement": {
                            "requirement_type": "confirmation method",
                            "expected_value": [
                                "histology",
                                "cytology"
                            ]
                        }
                    },
                    {
                        "exact_snippets": "documented METexon14-skipping mutations",
                        "criterion": "METexon14-skipping mutations",
                        "requirement": {
                            "requirement_type": "documentation",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "identified in primary or brain metastasis tissue",
                        "criterion": "mutation location",
                        "requirement": {
                            "requirement_type": "location",
                            "expected_value": [
                                "primary tissue",
                                "brain metastasis tissue"
                            ]
                        }
                    },
                    {
                        "exact_snippets": "identified ... in circulating tumor DNA in plasma (liquid biopsy)",
                        "criterion": "mutation location",
                        "requirement": {
                            "requirement_type": "location",
                            "expected_value": "circulating tumor DNA in plasma"
                        }
                    }
                ]
            },
            "logical_structure": {
                "exact_snippets": "failed",
                "criterion": "failed",
                "requirement": {
                    "requirement_type": "failed",
                    "expected_value": "failed"
                }
            }
        },
        {
            "identified_line": {
                "line": "2. Phase 1a, Group B: Patient must be surgical candidate for glioblastoma, as determined by treating physician, but not require immediate surgery.",
                "criterions": [
                    {
                        "exact_snippets": "surgical candidate for glioblastoma",
                        "criterion": "surgical candidacy for glioblastoma",
                        "requirement": {
                            "requirement_type": "determination",
                            "expected_value": "treating physician"
                        }
                    },
                    {
                        "exact_snippets": "not require immediate surgery",
                        "criterion": "immediate surgery requirement",
                        "requirement": {
                            "requirement_type": "necessity",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "surgical candidate for glioblastoma",
                                "criterion": "surgical candidacy for glioblastoma",
                                "requirement": {
                                    "requirement_type": "determination",
                                    "expected_value": "treating physician"
                                }
                            },
                            {
                                "not_criteria": {
                                    "exact_snippets": "not require immediate surgery",
                                    "criterion": "immediate surgery requirement",
                                    "requirement": {
                                        "requirement_type": "necessity",
                                        "expected_value": true
                                    }
                                }
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "3. Measurable disease",
                "criterions": [
                    {
                        "exact_snippets": "Measurable disease",
                        "criterion": "disease",
                        "requirement": {
                            "requirement_type": "measurability",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "exact_snippets": "failed",
                "criterion": "failed",
                "requirement": {
                    "requirement_type": "failed",
                    "expected_value": "failed"
                }
            }
        },
        {
            "identified_line": {
                "line": "a. Groups A and C: Presence of at least 1 independently verified measurable brain metastasis in accordance with a modified RANO-BM (see Section 6.1.6, Tumor Imaging and Assessment of Disease) that can be accurately assessed at baseline with ≥ 5 mm* in the longest diameter with MRI, which is suitable for accurate repeated measurements and that preferably was not previously irradiated or biopsied *and must be surgical candidate b. Group B: Presence of measurable glioblastoma, per RANO criteria, and that can be accurately assessed at baseline with ≥ 5 mm* in the longest diameter with MRI, which is suitable for accurate repeated measurements *and must be surgical candidate",
                "criterions": [
                    {
                        "exact_snippets": "Groups A and C: Presence of at least 1 independently verified measurable brain metastasis",
                        "criterion": "brain metastasis",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Groups A and C: Presence of at least 1 independently verified measurable brain metastasis",
                        "criterion": "brain metastasis",
                        "requirement": {
                            "requirement_type": "verification",
                            "expected_value": "independently verified"
                        }
                    },
                    {
                        "exact_snippets": "Groups A and C: Presence of at least 1 independently verified measurable brain metastasis",
                        "criterion": "brain metastasis",
                        "requirement": {
                            "requirement_type": "measurability",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Groups A and C: ... in accordance with a modified RANO-BM",
                        "criterion": "RANO-BM criteria",
                        "requirement": {
                            "requirement_type": "compliance",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Groups A and C: ... ≥ 5 mm* in the longest diameter with MRI",
                        "criterion": "brain metastasis size",
                        "requirement": {
                            "requirement_type": "size",
                            "expected_value": {
                                "operator": ">=",
                                "value": 5,
                                "unit": "mm"
                            }
                        }
                    },
                    {
                        "exact_snippets": "Groups A and C: ... suitable for accurate repeated measurements",
                        "criterion": "suitability for repeated measurements",
                        "requirement": {
                            "requirement_type": "suitability",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Groups A and C: ... preferably was not previously irradiated or biopsied",
                        "criterion": "prior treatment",
                        "requirement": {
                            "requirement_type": "irradiation or biopsy",
                            "expected_value": "preferably not previously treated"
                        }
                    },
                    {
                        "exact_snippets": "Groups A and C: ... must be surgical candidate",
                        "criterion": "surgical candidacy",
                        "requirement": {
                            "requirement_type": "candidacy",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Group B: Presence of measurable glioblastoma",
                        "criterion": "glioblastoma",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Group B: Presence of measurable glioblastoma",
                        "criterion": "glioblastoma",
                        "requirement": {
                            "requirement_type": "measurability",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Group B: ... per RANO criteria",
                        "criterion": "RANO criteria",
                        "requirement": {
                            "requirement_type": "compliance",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Group B: ... ≥ 5 mm* in the longest diameter with MRI",
                        "criterion": "glioblastoma size",
                        "requirement": {
                            "requirement_type": "size",
                            "expected_value": {
                                "operator": ">=",
                                "value": 5,
                                "unit": "mm"
                            }
                        }
                    },
                    {
                        "exact_snippets": "Group B: ... suitable for accurate repeated measurements",
                        "criterion": "suitability for repeated measurements",
                        "requirement": {
                            "requirement_type": "suitability",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Group B: ... must be surgical candidate",
                        "criterion": "surgical candidacy",
                        "requirement": {
                            "requirement_type": "candidacy",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "exact_snippets": "failed",
                "criterion": "failed",
                "requirement": {
                    "requirement_type": "failed",
                    "expected_value": "failed"
                }
            }
        },
        {
            "identified_line": {
                "line": "4. Willing to undergo CSF sampling via lumbar puncture. 5. No medical contraindication to lumbar puncture (to include severe coagulopathy, radiographic concern for impending herniation or obstructive hydrocephalus, or soft tissue infection at puncture site, as outlined in MD Anderson institutional policy).",
                "criterions": [
                    {
                        "exact_snippets": "Willing to undergo CSF sampling via lumbar puncture",
                        "criterion": "willingness to undergo CSF sampling",
                        "requirement": {
                            "requirement_type": "willingness",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "No medical contraindication to lumbar puncture",
                        "criterion": "medical contraindication to lumbar puncture",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "severe coagulopathy",
                        "criterion": "severe coagulopathy",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "radiographic concern for impending herniation",
                        "criterion": "radiographic concern for impending herniation",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "obstructive hydrocephalus",
                        "criterion": "obstructive hydrocephalus",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "soft tissue infection at puncture site",
                        "criterion": "soft tissue infection at puncture site",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "exact_snippets": "failed",
                "criterion": "failed",
                "requirement": {
                    "requirement_type": "failed",
                    "expected_value": "failed"
                }
            }
        },
        {
            "identified_line": {
                "line": "1. Patient may still enroll but LP may be deferred if at any time the treating physician determines that it would be unsafe to perform this procedure due to the characteristics (size, associated edema, etc) of the brain tumor 6. If taking steroids, stable or decreasing dose of steroids for at least 5 days prior to enrollment; no more than 4 mg dexamethasone (or equivalent) total per day for patients with brain metastasis, and no more than 8 mg per day for patients with glioblastoma.",
                "criterions": [
                    {
                        "exact_snippets": "characteristics (size, associated edema, etc) of the brain tumor",
                        "criterion": "brain tumor characteristics",
                        "requirement": {
                            "requirement_type": "safety",
                            "expected_value": "safe to perform procedure"
                        }
                    },
                    {
                        "exact_snippets": "If taking steroids, stable or decreasing dose of steroids for at least 5 days prior to enrollment",
                        "criterion": "steroid dose stability",
                        "requirement": {
                            "requirement_type": "stability",
                            "expected_value": "stable or decreasing for at least 5 days"
                        }
                    },
                    {
                        "exact_snippets": "no more than 4 mg dexamethasone (or equivalent) total per day for patients with brain metastasis",
                        "criterion": "dexamethasone dose for brain metastasis",
                        "requirement": {
                            "requirement_type": "dose",
                            "expected_value": {
                                "operator": "<=",
                                "value": 4,
                                "unit": "mg per day"
                            }
                        }
                    },
                    {
                        "exact_snippets": "no more than 8 mg per day for patients with glioblastoma",
                        "criterion": "dexamethasone dose for glioblastoma",
                        "requirement": {
                            "requirement_type": "dose",
                            "expected_value": {
                                "operator": "<=",
                                "value": 8,
                                "unit": "mg per day"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "exact_snippets": "failed",
                "criterion": "failed",
                "requirement": {
                    "requirement_type": "failed",
                    "expected_value": "failed"
                }
            }
        },
        {
            "identified_line": {
                "line": "7. Demonstrate adequate organ function as defined in Table 1; all screening labs should be performed within 14 days prior to registration (see Table 1).",
                "criterions": [
                    {
                        "exact_snippets": "adequate organ function",
                        "criterion": "organ function",
                        "requirement": {
                            "requirement_type": "adequacy",
                            "expected_value": "as defined in Table 1"
                        }
                    },
                    {
                        "exact_snippets": "all screening labs should be performed within 14 days prior to registration",
                        "criterion": "screening labs",
                        "requirement": {
                            "requirement_type": "timing",
                            "expected_value": "within 14 days prior to registration"
                        }
                    }
                ]
            },
            "logical_structure": {
                "exact_snippets": "failed",
                "criterion": "failed",
                "requirement": {
                    "requirement_type": "failed",
                    "expected_value": "failed"
                }
            }
        },
        {
            "identified_line": {
                "line": "9. Female patients of childbearing potential should be willing to use 2 methods of birth control or be surgically sterile, or abstain from heterosexual activity, for the course of the study through 28 days after the last dose of study medication. Participants of childbearing potential are those who have not been surgically sterilized or have not been free from menses for > 1 year.",
                "criterions": [
                    {
                        "exact_snippets": "Female patients of childbearing potential",
                        "criterion": "gender and reproductive status",
                        "requirement": {
                            "requirement_type": "gender",
                            "expected_value": "female"
                        }
                    },
                    {
                        "exact_snippets": "Female patients of childbearing potential",
                        "criterion": "gender and reproductive status",
                        "requirement": {
                            "requirement_type": "reproductive status",
                            "expected_value": "childbearing potential"
                        }
                    },
                    {
                        "exact_snippets": "willing to use 2 methods of birth control",
                        "criterion": "birth control methods",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2,
                                "unit": "methods"
                            }
                        }
                    },
                    {
                        "exact_snippets": "be surgically sterile",
                        "criterion": "surgical sterility",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "abstain from heterosexual activity",
                        "criterion": "sexual activity",
                        "requirement": {
                            "requirement_type": "abstinence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "for the course of the study through 28 days after the last dose of study medication",
                        "criterion": "duration of birth control or abstinence",
                        "requirement": {
                            "requirement_type": "duration",
                            "expected_value": "course of the study through 28 days after the last dose of study medication"
                        }
                    },
                    {
                        "exact_snippets": "Participants of childbearing potential are those who have not been surgically sterilized",
                        "criterion": "surgical sterilization",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "have not been free from menses for > 1 year",
                        "criterion": "menstrual status",
                        "requirement": {
                            "requirement_type": "duration without menses",
                            "expected_value": {
                                "operator": ">",
                                "value": 1,
                                "unit": "year"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "exact_snippets": "failed",
                "criterion": "failed",
                "requirement": {
                    "requirement_type": "failed",
                    "expected_value": "failed"
                }
            }
        }
    ],
    "failed_exclusion": [
        {
            "identified_line": {
                "line": "1. Currently participating in or has participated in a study of an investigational agent (with the exception of participating in which the investigational agent was a 1st, 2nd, or 3rd generation EGFR-TKI) within 4 weeks prior to study enrollment.",
                "criterions": [
                    {
                        "exact_snippets": "Currently participating in or has participated in a study of an investigational agent",
                        "criterion": "participation in a study of an investigational agent",
                        "requirement": {
                            "requirement_type": "participation",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "participating in which the investigational agent was a 1st, 2nd, or 3rd generation EGFR-TKI",
                        "criterion": "participation in a study with 1st, 2nd, or 3rd generation EGFR-TKI",
                        "requirement": {
                            "requirement_type": "participation",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "within 4 weeks prior to study enrollment",
                        "criterion": "time since last participation in a study",
                        "requirement": {
                            "requirement_type": "time since participation",
                            "expected_value": {
                                "operator": ">=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "condition": {
                    "and_criteria": [
                        {
                            "and_criteria": [
                                {
                                    "exact_snippets": "Currently participating in or has participated in a study of an investigational agent",
                                    "criterion": "participation in a study of an investigational agent",
                                    "requirement": {
                                        "requirement_type": "participation",
                                        "expected_value": true
                                    }
                                },
                                {
                                    "exact_snippets": "within 4 weeks prior to study enrollment",
                                    "criterion": "time since last participation in a study",
                                    "requirement": {
                                        "requirement_type": "time since participation",
                                        "expected_value": {
                                            "operator": "<",
                                            "value": 4,
                                            "unit": "weeks"
                                        }
                                    }
                                }
                            ]
                        }
                    ]
                },
                "then_criteria": {
                    "not_criteria": {
                        "exact_snippets": "participating in which the investigational agent was a 1st, 2nd, or 3rd generation EGFR-TKI",
                        "criterion": "participation in a study with 1st, 2nd, or 3rd generation EGFR-TKI",
                        "requirement": {
                            "requirement_type": "participation",
                            "expected_value": true
                        }
                    }
                },
                "else_criteria": null
            }
        },
        {
            "identified_line": {
                "line": "* Serious arrhythmia",
                "criterions": [
                    {
                        "exact_snippets": "Serious arrhythmia",
                        "criterion": "arrhythmia",
                        "requirement": {
                            "requirement_type": "severity",
                            "expected_value": "serious"
                        }
                    }
                ]
            },
            "logical_structure": {
                "exact_snippets": "failed",
                "criterion": "failed",
                "requirement": {
                    "requirement_type": "failed",
                    "expected_value": "failed"
                }
            }
        },
        {
            "identified_line": {
                "line": "* Unstable angina pectoris",
                "criterions": [
                    {
                        "exact_snippets": "Unstable angina pectoris",
                        "criterion": "unstable angina pectoris",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "exact_snippets": "failed",
                "criterion": "failed",
                "requirement": {
                    "requirement_type": "failed",
                    "expected_value": "failed"
                }
            }
        },
        {
            "identified_line": {
                "line": "* Congestive Heart Failure New York Heart Association III and IV",
                "criterions": [
                    {
                        "exact_snippets": "Congestive Heart Failure New York Heart Association III and IV",
                        "criterion": "Congestive Heart Failure",
                        "requirement": {
                            "requirement_type": "severity",
                            "expected_value": [
                                "New York Heart Association III",
                                "New York Heart Association IV"
                            ]
                        }
                    }
                ]
            },
            "logical_structure": {
                "exact_snippets": "failed",
                "criterion": "failed",
                "requirement": {
                    "requirement_type": "failed",
                    "expected_value": "failed"
                }
            }
        },
        {
            "identified_line": {
                "line": "* Myocardial infarction, stroke, or transient ischemic attack within the last 6 months prior to study entry.",
                "criterions": [
                    {
                        "exact_snippets": "Myocardial infarction ... within the last 6 months prior to study entry.",
                        "criterion": "myocardial infarction",
                        "requirement": {
                            "requirement_type": "time since event",
                            "expected_value": {
                                "operator": "<=",
                                "value": 6,
                                "unit": "months"
                            }
                        }
                    },
                    {
                        "exact_snippets": "stroke ... within the last 6 months prior to study entry.",
                        "criterion": "stroke",
                        "requirement": {
                            "requirement_type": "time since event",
                            "expected_value": {
                                "operator": "<=",
                                "value": 6,
                                "unit": "months"
                            }
                        }
                    },
                    {
                        "exact_snippets": "transient ischemic attack within the last 6 months prior to study entry.",
                        "criterion": "transient ischemic attack",
                        "requirement": {
                            "requirement_type": "time since event",
                            "expected_value": {
                                "operator": "<=",
                                "value": 6,
                                "unit": "months"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "exact_snippets": "failed",
                "criterion": "failed",
                "requirement": {
                    "requirement_type": "failed",
                    "expected_value": "failed"
                }
            }
        },
        {
            "identified_line": {
                "line": "* Any factors that increase the risk of QTc prolongation or risk of arrhythmic events such as hypokalemia, congenital long QT syndrome, family history of long QT syndrome or unexplained sudden death under 40 years of age in first degree relatives, or any concomitant medication known to prolong the QT interval and cause Torsade de Pointes.",
                "criterions": [
                    {
                        "exact_snippets": "factors that increase the risk of QTc prolongation or risk of arrhythmic events",
                        "criterion": "risk factors for QTc prolongation or arrhythmic events",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "hypokalemia",
                        "criterion": "hypokalemia",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "congenital long QT syndrome",
                        "criterion": "congenital long QT syndrome",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "family history of long QT syndrome",
                        "criterion": "family history of long QT syndrome",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "unexplained sudden death under 40 years of age in first degree relatives",
                        "criterion": "unexplained sudden death under 40 years of age in first degree relatives",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "any concomitant medication known to prolong the QT interval and cause Torsade de Pointes",
                        "criterion": "concomitant medication known to prolong the QT interval and cause Torsade de Pointes",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "exact_snippets": "failed",
                "criterion": "failed",
                "requirement": {
                    "requirement_type": "failed",
                    "expected_value": "failed"
                }
            }
        },
        {
            "identified_line": {
                "line": "11. Hypertension uncontrolled by standard therapies (not stabilized to < 150/90 mmHg).",
                "criterions": [
                    {
                        "exact_snippets": "Hypertension uncontrolled by standard therapies",
                        "criterion": "hypertension",
                        "requirement": {
                            "requirement_type": "control",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "not stabilized to < 150/90 mmHg",
                        "criterion": "blood pressure",
                        "requirement": {
                            "requirement_type": "stabilization",
                            "expected_value": {
                                "operator": "<",
                                "value": 150,
                                "unit": "mmHg"
                            }
                        }
                    },
                    {
                        "exact_snippets": "not stabilized to < 150/90 mmHg",
                        "criterion": "blood pressure",
                        "requirement": {
                            "requirement_type": "stabilization",
                            "expected_value": {
                                "operator": "<",
                                "value": 90,
                                "unit": "mmHg"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "exact_snippets": "failed",
                "criterion": "failed",
                "requirement": {
                    "requirement_type": "failed",
                    "expected_value": "failed"
                }
            }
        },
        {
            "identified_line": {
                "line": "18. Participants currently receiving (or unable to stop use at least 1 week prior to enrollment) medications or herbal supplements known to be potent inducers of CYP3A4.",
                "criterions": [
                    {
                        "exact_snippets": "Participants currently receiving (or unable to stop use at least 1 week prior to enrollment) medications or herbal supplements known to be potent inducers of CYP3A4.",
                        "criterion": "use of medications or herbal supplements",
                        "requirement": {
                            "requirement_type": "type",
                            "expected_value": "potent inducers of CYP3A4"
                        }
                    },
                    {
                        "exact_snippets": "Participants currently receiving (or unable to stop use at least 1 week prior to enrollment) medications or herbal supplements known to be potent inducers of CYP3A4.",
                        "criterion": "use of medications or herbal supplements",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": "currently receiving or unable to stop use at least 1 week prior to enrollment"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Participants currently receiving (or unable to stop use at least 1 week prior to enrollment) medications or herbal supplements known to be potent inducers of CYP3A4.",
                                "criterion": "use of medications or herbal supplements",
                                "requirement": {
                                    "requirement_type": "type",
                                    "expected_value": "potent inducers of CYP3A4"
                                }
                            },
                            {
                                "exact_snippets": "Participants currently receiving (or unable to stop use at least 1 week prior to enrollment) medications or herbal supplements known to be potent inducers of CYP3A4.",
                                "criterion": "use of medications or herbal supplements",
                                "requirement": {
                                    "requirement_type": "status",
                                    "expected_value": "currently receiving"
                                }
                            }
                        ]
                    },
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Participants currently receiving (or unable to stop use at least 1 week prior to enrollment) medications or herbal supplements known to be potent inducers of CYP3A4.",
                                "criterion": "use of medications or herbal supplements",
                                "requirement": {
                                    "requirement_type": "type",
                                    "expected_value": "potent inducers of CYP3A4"
                                }
                            },
                            {
                                "exact_snippets": "Participants currently receiving (or unable to stop use at least 1 week prior to enrollment) medications or herbal supplements known to be potent inducers of CYP3A4.",
                                "criterion": "use of medications or herbal supplements",
                                "requirement": {
                                    "requirement_type": "status",
                                    "expected_value": "unable to stop use at least 1 week prior to enrollment"
                                }
                            }
                        ]
                    }
                ]
            }
        }
    ],
    "failed_miscellaneous": []
}