{
    "info": {
        "nct_id": "NCT03417882",
        "official_title": "A Pilot, Open-Label, Multi-Center, Multi-Dose Study of GRN-1201 Added to Pembrolizumab in Subjects With Non-Small Cell Lung Cancer With High PD-L1 Expression",
        "inclusion_criteria": "1. Be male or female at least 18 years of age (at the time consent is obtained);\n2. Be able and willing to provide written informed consent and to comply with all requirements of study participation (including all study procedures);\n3. Have histologically- or cytologically-confirmed diagnosis of Stage IV NSCLC Have newly diagnosed, metastatic NSCLC with PD-L1 TPS ≥ 50% (as determined by central lab using the 22C3 pharmDx kit) Note: Subjects with documentation of PD-L1 TPS ≥50% by IHC analysis using the 22C3 pharmDx kit will not require repeat PD-L1 testing by central laboratory and\n4. Have no prior systemic chemotherapy for metastatic disease: at least 6 months since prior adjuvant chemotherapy\n5. Be HLA-A*02+ as determined by Central Laboratory;\n6. Be able to provide formalin fixed, paraffin-embedded (FFPE) tumor tissue obtained from either a core or excisional tumor biopsy;\n7. Have a life expectancy of at least 3 months;\n8. Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;\n9. Have measurable disease based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 as determined by the site study team. Target tumor lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions;\n10. Has adequate organ function as defined by:\n\n    * Absolute neutrophil count ≥ 1,500/µL\n    * Platelets ≥ 100,000/µL\n    * Hemoglobin ≥ 9 g/dL (without transfusion for at least one month)\n    * Serum creatinine ≤ 1.5 x Upper Limit of Normal (ULN) OR\n\n      o glomerular filtration rate (GFR) ≥30mL/min if serum creatinine > 1.5 x ULN, creatinine clearance may be calculated using the institutional/laboratory standard method\n    * Serum total bilirubin ≤ 1.5 x ULN OR\n\n      o Direct bilirubin ≤ ULN for subjects with total bilirubin >1.5 x ULN\n    * Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 x ULN (≤ 5 x ULN for subjects with liver metastases)\n    * Albumin ≥2.5mg/dL\n    * International Normalized Ratio (INR) or PT/aPTT <1.5 x ULN. For subjects receiving anticoagulation therapy, PT/aPTT and INR should not be greater than the recommended range for the intended use of the anticoagulant\n11. Have recovered from the effects of any prior radiotherapy or surgery;\n12. Female subjects of childbearing potential must have a negative serum human chorionic gonadotropic (hCG) test within 1 week of Day 1 (pregnancy test not required for subjects with bilateral oophorectomy and/or hysterectomy or for those subjects who are >1 year post-menopausal); and\n13. All female and male subjects of reproductive potential must agree to use an effective method of contraception, as determined by the Investigator, during and for 4 months after the last dose of study treatment.\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "1. Is currently participating in or has participated in a study of an investigational agent or using an investigational device within 14 days of the first dose of treatment;\n2. Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy > 10 mg prednisone or equivalent per day or any other form of immunosuppressive therapy within 7 days prior to the first dose of study treatment;\n3. Has undergone major surgery within 3 weeks of Study Day 1, Subject must have recovered adequately from any toxicity and/or complications from the intervention prior to starting therapy;\n4. Has a known additional malignancy that is progressing or requires systemic treatment. Exceptions include basal cell carcinoma of the skin, squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer.\n5. Has received transfusion of blood products (including platelets or red blood cells) or administration of colony stimulating factors (including granulocyte colony-stimulating factor [G-CSF], GM-CSF or recombinant erythropoietin) within 4 weeks prior to study Day 1;\n6. Has known active central nervous system (CNS) metastases NOTE: Subjects with previously treated brain metastases may participate provided they are stable (without evidence of progression by imaging [using the identical imaging modality for each assessment, either magnetic resonance imaging (MRI) or computerized tomography (CT) scan] for at least four weeks prior to the first dose of study treatment and any neurologic symptoms have returned to baseline), have no evidence of new or enlarging brain metastases, and are not using steroids for at least 7 days prior to study treatment;\n7. Has carcinomatous meningitis;\n8. Has an active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment NOTE: Subjects with vitiligo or resolved childhood asthma/atopy would be an exception to this rule. Subjects that require intermittent use of bronchodilators or local steroid injections would not be excluded from the study;\n9. Has history of interstitial lung disease, or history of (non-infectious) pneumonitis that required steroids, or current pneumonitis;\n10. Has an active infection requiring systemic therapy NOTE: Antibiotic therapy must have been completed a minimum of 3 days prior to start of study treatment;\n11. Has known active Hepatitis B (e.g., HBsAg reactive) or Hepatitis C (e.g., HCV RNA [qualitative] is detected);\n12. History of myocardial infarction, unstable angina, cardiac or other vascular stenting, angioplasty, or surgery within 6 months prior to day 1 of study treatment;\n13. Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the subject's participation for the full duration of the study, or is not in the best interest of this subject to participate, in the opinion of the treating investigator;\n14. Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the study;\n15. Has received a live virus vaccine within 30 days of the planned first dose of study therapy NOTE: seasonal influenza vaccines for injection which are generally inactivated flu vaccines are permitted; however, intranasal influenza vaccines (e.g., Flu-Mist®) are live attenuated vaccines and are not permitted;\n16. Is pregnant, breastfeeding, or expecting to conceive or father a child within the projected duration of the study including 120 days following the last dose of study treatment; or\n17. Has any concurrent medical condition that, in the opinion of the Investigator, would complicate or compromise compliance with the study or the well-being of the subject.\n18. Have an EGFR or ALK genomic tumor aberrations for which targeted therapy with an EGFR or ALK inhibitor is indicated.\n\n    Additional Exclusion Criteria for Cohort 2:\n19. Has had prior treatment with an anti-PD-1 or anti-PD-L1 antibody, anti-cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4) antibody (including ipilimumab) or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways;",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "identified_line": {
                "line": "1. Be male or female at least 18 years of age (at the time consent is obtained);",
                "criterions": [
                    {
                        "exact_snippets": "Be male or female",
                        "criterion": "gender",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": [
                                "male",
                                "female"
                            ]
                        }
                    },
                    {
                        "exact_snippets": "at least 18 years of age",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "minimum age",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "or_criteria": [
                            {
                                "exact_snippets": "Be male or female",
                                "criterion": "gender",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": [
                                        "male",
                                        "female"
                                    ]
                                }
                            }
                        ]
                    },
                    {
                        "exact_snippets": "at least 18 years of age",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "minimum age",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "2. Be able and willing to provide written informed consent and to comply with all requirements of study participation (including all study procedures);",
                "criterions": [
                    {
                        "exact_snippets": "Be able and willing to provide written informed consent",
                        "criterion": "informed consent",
                        "requirement": {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Be able and willing to provide written informed consent",
                        "criterion": "informed consent",
                        "requirement": {
                            "requirement_type": "willingness",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "comply with all requirements of study participation (including all study procedures)",
                        "criterion": "study participation compliance",
                        "requirement": {
                            "requirement_type": "willingness",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Be able and willing to provide written informed consent",
                                "criterion": "informed consent",
                                "requirement": {
                                    "requirement_type": "ability",
                                    "expected_value": true
                                }
                            },
                            {
                                "exact_snippets": "Be able and willing to provide written informed consent",
                                "criterion": "informed consent",
                                "requirement": {
                                    "requirement_type": "willingness",
                                    "expected_value": true
                                }
                            }
                        ]
                    },
                    {
                        "exact_snippets": "comply with all requirements of study participation (including all study procedures)",
                        "criterion": "study participation compliance",
                        "requirement": {
                            "requirement_type": "willingness",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "3. Have histologically- or cytologically-confirmed diagnosis of Stage IV NSCLC Have newly diagnosed, metastatic NSCLC with PD-L1 TPS ≥ 50% (as determined by central lab using the 22C3 pharmDx kit) Note: Subjects with documentation of PD-L1 TPS ≥50% by IHC analysis using the 22C3 pharmDx kit will not require repeat PD-L1 testing by central laboratory and",
                "criterions": [
                    {
                        "exact_snippets": "histologically- or cytologically-confirmed diagnosis of Stage IV NSCLC",
                        "criterion": "Stage IV NSCLC diagnosis",
                        "requirement": {
                            "requirement_type": "confirmation method",
                            "expected_value": [
                                "histologically",
                                "cytologically"
                            ]
                        }
                    },
                    {
                        "exact_snippets": "newly diagnosed, metastatic NSCLC",
                        "criterion": "metastatic NSCLC",
                        "requirement": {
                            "requirement_type": "diagnosis status",
                            "expected_value": "newly diagnosed"
                        }
                    },
                    {
                        "exact_snippets": "PD-L1 TPS ≥ 50% (as determined by central lab using the 22C3 pharmDx kit)",
                        "criterion": "PD-L1 TPS",
                        "requirement": {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">=",
                                "value": 50,
                                "unit": "%"
                            }
                        }
                    },
                    {
                        "exact_snippets": "PD-L1 TPS ≥ 50% (as determined by central lab using the 22C3 pharmDx kit)",
                        "criterion": "PD-L1 TPS",
                        "requirement": {
                            "requirement_type": "determination method",
                            "expected_value": "central lab using the 22C3 pharmDx kit"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "histologically- or cytologically-confirmed diagnosis of Stage IV NSCLC",
                                "criterion": "Stage IV NSCLC diagnosis",
                                "requirement": {
                                    "requirement_type": "confirmation method",
                                    "expected_value": [
                                        "histologically",
                                        "cytologically"
                                    ]
                                }
                            },
                            {
                                "exact_snippets": "newly diagnosed, metastatic NSCLC",
                                "criterion": "metastatic NSCLC",
                                "requirement": {
                                    "requirement_type": "diagnosis status",
                                    "expected_value": "newly diagnosed"
                                }
                            }
                        ]
                    },
                    {
                        "or_criteria": [
                            {
                                "and_criteria": [
                                    {
                                        "exact_snippets": "PD-L1 TPS ≥ 50% (as determined by central lab using the 22C3 pharmDx kit)",
                                        "criterion": "PD-L1 TPS",
                                        "requirement": {
                                            "requirement_type": "value",
                                            "expected_value": {
                                                "operator": ">=",
                                                "value": 50,
                                                "unit": "%"
                                            }
                                        }
                                    },
                                    {
                                        "exact_snippets": "PD-L1 TPS ≥ 50% (as determined by central lab using the 22C3 pharmDx kit)",
                                        "criterion": "PD-L1 TPS",
                                        "requirement": {
                                            "requirement_type": "determination method",
                                            "expected_value": "central lab using the 22C3 pharmDx kit"
                                        }
                                    }
                                ]
                            },
                            {
                                "exact_snippets": "PD-L1 TPS ≥ 50% (as determined by central lab using the 22C3 pharmDx kit)",
                                "criterion": "PD-L1 TPS",
                                "requirement": {
                                    "requirement_type": "value",
                                    "expected_value": {
                                        "operator": ">=",
                                        "value": 50,
                                        "unit": "%"
                                    }
                                }
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "4. Have no prior systemic chemotherapy for metastatic disease: at least 6 months since prior adjuvant chemotherapy",
                "criterions": [
                    {
                        "exact_snippets": "no prior systemic chemotherapy for metastatic disease",
                        "criterion": "prior systemic chemotherapy for metastatic disease",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "at least 6 months since prior adjuvant chemotherapy",
                        "criterion": "time since prior adjuvant chemotherapy",
                        "requirement": {
                            "requirement_type": "time since",
                            "expected_value": {
                                "operator": ">=",
                                "value": 6,
                                "unit": "months"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "no prior systemic chemotherapy for metastatic disease",
                        "criterion": "prior systemic chemotherapy for metastatic disease",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "at least 6 months since prior adjuvant chemotherapy",
                        "criterion": "time since prior adjuvant chemotherapy",
                        "requirement": {
                            "requirement_type": "time since",
                            "expected_value": {
                                "operator": ">=",
                                "value": 6,
                                "unit": "months"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "5. Be HLA-A*02+ as determined by Central Laboratory;",
                "criterions": [
                    {
                        "exact_snippets": "Be HLA-A*02+",
                        "criterion": "HLA-A*02 status",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": "positive"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Be HLA-A*02+",
                        "criterion": "HLA-A*02 status",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": "positive"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "6. Be able to provide formalin fixed, paraffin-embedded (FFPE) tumor tissue obtained from either a core or excisional tumor biopsy;",
                "criterions": [
                    {
                        "exact_snippets": "formalin fixed, paraffin-embedded (FFPE) tumor tissue",
                        "criterion": "FFPE tumor tissue",
                        "requirement": {
                            "requirement_type": "availability",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "formalin fixed, paraffin-embedded (FFPE) tumor tissue",
                        "criterion": "FFPE tumor tissue",
                        "requirement": {
                            "requirement_type": "availability",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "7. Have a life expectancy of at least 3 months;",
                "criterions": [
                    {
                        "exact_snippets": "life expectancy of at least 3 months",
                        "criterion": "life expectancy",
                        "requirement": {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 3,
                                "unit": "months"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "life expectancy of at least 3 months",
                        "criterion": "life expectancy",
                        "requirement": {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 3,
                                "unit": "months"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "8. Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;",
                "criterions": [
                    {
                        "exact_snippets": "Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1",
                        "criterion": "ECOG performance status",
                        "requirement": {
                            "requirement_type": "value",
                            "expected_value": [
                                "0",
                                "1"
                            ]
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1",
                        "criterion": "ECOG performance status",
                        "requirement": {
                            "requirement_type": "value",
                            "expected_value": [
                                "0",
                                "1"
                            ]
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "9. Have measurable disease based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 as determined by the site study team. Target tumor lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions;",
                "criterions": [
                    {
                        "exact_snippets": "measurable disease based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1",
                        "criterion": "measurable disease",
                        "requirement": {
                            "requirement_type": "evaluation criteria",
                            "expected_value": "Response Evaluation Criteria in Solid Tumors (RECIST) 1.1"
                        }
                    },
                    {
                        "exact_snippets": "Target tumor lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated",
                        "criterion": "target tumor lesions in previously irradiated area",
                        "requirement": {
                            "requirement_type": "measurability",
                            "expected_value": "progression demonstrated"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "measurable disease based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1",
                                "criterion": "measurable disease",
                                "requirement": {
                                    "requirement_type": "evaluation criteria",
                                    "expected_value": "Response Evaluation Criteria in Solid Tumors (RECIST) 1.1"
                                }
                            },
                            {
                                "not_criteria": {
                                    "exact_snippets": "Target tumor lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated",
                                    "criterion": "target tumor lesions in previously irradiated area",
                                    "requirement": {
                                        "requirement_type": "measurability",
                                        "expected_value": "progression demonstrated"
                                    }
                                }
                            }
                        ]
                    },
                    {
                        "exact_snippets": "Target tumor lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated",
                        "criterion": "target tumor lesions in previously irradiated area",
                        "requirement": {
                            "requirement_type": "measurability",
                            "expected_value": "progression demonstrated"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "10. Has adequate organ function as defined by:",
                "criterions": [
                    {
                        "exact_snippets": "adequate organ function",
                        "criterion": "organ function",
                        "requirement": {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "adequate organ function",
                        "criterion": "organ function",
                        "requirement": {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Absolute neutrophil count ≥ 1,500/µL",
                "criterions": [
                    {
                        "exact_snippets": "Absolute neutrophil count ≥ 1,500/µL",
                        "criterion": "absolute neutrophil count",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1500,
                                "unit": "µL"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Absolute neutrophil count ≥ 1,500/µL",
                        "criterion": "absolute neutrophil count",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1500,
                                "unit": "µL"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Platelets ≥ 100,000/µL",
                "criterions": [
                    {
                        "exact_snippets": "Platelets ≥ 100,000/µL",
                        "criterion": "platelet count",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 100000,
                                "unit": "/µL"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Platelets ≥ 100,000/µL",
                        "criterion": "platelet count",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 100000,
                                "unit": "/µL"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Hemoglobin ≥ 9 g/dL (without transfusion for at least one month)",
                "criterions": [
                    {
                        "exact_snippets": "Hemoglobin ≥ 9 g/dL",
                        "criterion": "hemoglobin level",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 9,
                                "unit": "g/dL"
                            }
                        }
                    },
                    {
                        "exact_snippets": "without transfusion for at least one month",
                        "criterion": "transfusion",
                        "requirement": {
                            "requirement_type": "absence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "without transfusion for at least one month",
                        "criterion": "transfusion",
                        "requirement": {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1,
                                "unit": "month"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Hemoglobin ≥ 9 g/dL",
                                "criterion": "hemoglobin level",
                                "requirement": {
                                    "requirement_type": "quantity",
                                    "expected_value": {
                                        "operator": ">=",
                                        "value": 9,
                                        "unit": "g/dL"
                                    }
                                }
                            },
                            {
                                "and_criteria": [
                                    {
                                        "exact_snippets": "without transfusion for at least one month",
                                        "criterion": "transfusion",
                                        "requirement": {
                                            "requirement_type": "absence",
                                            "expected_value": true
                                        }
                                    },
                                    {
                                        "exact_snippets": "without transfusion for at least one month",
                                        "criterion": "transfusion",
                                        "requirement": {
                                            "requirement_type": "duration",
                                            "expected_value": {
                                                "operator": ">=",
                                                "value": 1,
                                                "unit": "month"
                                            }
                                        }
                                    }
                                ]
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "o glomerular filtration rate (GFR) ≥30mL/min if serum creatinine > 1.5 x ULN, creatinine clearance may be calculated using the institutional/laboratory standard method",
                "criterions": [
                    {
                        "exact_snippets": "glomerular filtration rate (GFR) ≥30mL/min",
                        "criterion": "glomerular filtration rate (GFR)",
                        "requirement": {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">=",
                                "value": 30,
                                "unit": "mL/min"
                            }
                        }
                    },
                    {
                        "exact_snippets": "serum creatinine > 1.5 x ULN",
                        "criterion": "serum creatinine",
                        "requirement": {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">",
                                "value": 1.5,
                                "unit": "x ULN"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "condition": {
                    "exact_snippets": "serum creatinine > 1.5 x ULN",
                    "criterion": "serum creatinine",
                    "requirement": {
                        "requirement_type": "value",
                        "expected_value": {
                            "operator": ">",
                            "value": 1.5,
                            "unit": "x ULN"
                        }
                    }
                },
                "then_criteria": {
                    "exact_snippets": "glomerular filtration rate (GFR) ≥30mL/min",
                    "criterion": "glomerular filtration rate (GFR)",
                    "requirement": {
                        "requirement_type": "value",
                        "expected_value": {
                            "operator": ">=",
                            "value": 30,
                            "unit": "mL/min"
                        }
                    }
                },
                "else_criteria": null
            }
        },
        {
            "identified_line": {
                "line": "o Direct bilirubin ≤ ULN for subjects with total bilirubin >1.5 x ULN",
                "criterions": [
                    {
                        "exact_snippets": "Direct bilirubin ≤ ULN",
                        "criterion": "direct bilirubin",
                        "requirement": {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1,
                                "unit": "ULN"
                            }
                        }
                    },
                    {
                        "exact_snippets": "total bilirubin >1.5 x ULN",
                        "criterion": "total bilirubin",
                        "requirement": {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">",
                                "value": 1.5,
                                "unit": "ULN"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "condition": {
                    "exact_snippets": "total bilirubin >1.5 x ULN",
                    "criterion": "total bilirubin",
                    "requirement": {
                        "requirement_type": "level",
                        "expected_value": {
                            "operator": ">",
                            "value": 1.5,
                            "unit": "ULN"
                        }
                    }
                },
                "then_criteria": {
                    "exact_snippets": "Direct bilirubin ≤ ULN",
                    "criterion": "direct bilirubin",
                    "requirement": {
                        "requirement_type": "level",
                        "expected_value": {
                            "operator": "<=",
                            "value": 1,
                            "unit": "ULN"
                        }
                    }
                },
                "else_criteria": null
            }
        },
        {
            "identified_line": {
                "line": "* Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 x ULN (≤ 5 x ULN for subjects with liver metastases)",
                "criterions": [
                    {
                        "exact_snippets": "Alanine aminotransferase (ALT) ... ≤ 2.5 x ULN (≤ 5 x ULN for subjects with liver metastases)",
                        "criterion": "Alanine aminotransferase (ALT)",
                        "requirement": {
                            "requirement_type": "level",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 2.5,
                                        "unit": "x ULN"
                                    }
                                ]
                            }
                        }
                    },
                    {
                        "exact_snippets": "Alanine aminotransferase (ALT) ... ≤ 2.5 x ULN (≤ 5 x ULN for subjects with liver metastases)",
                        "criterion": "Alanine aminotransferase (ALT)",
                        "requirement": {
                            "requirement_type": "level with liver metastases",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 5,
                                        "unit": "x ULN"
                                    }
                                ]
                            }
                        }
                    },
                    {
                        "exact_snippets": "aspartate aminotransferase (AST) ≤ 2.5 x ULN (≤ 5 x ULN for subjects with liver metastases)",
                        "criterion": "aspartate aminotransferase (AST)",
                        "requirement": {
                            "requirement_type": "level",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 2.5,
                                        "unit": "x ULN"
                                    }
                                ]
                            }
                        }
                    },
                    {
                        "exact_snippets": "aspartate aminotransferase (AST) ≤ 2.5 x ULN (≤ 5 x ULN for subjects with liver metastases)",
                        "criterion": "aspartate aminotransferase (AST)",
                        "requirement": {
                            "requirement_type": "level with liver metastases",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 5,
                                        "unit": "x ULN"
                                    }
                                ]
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "condition": {
                    "exact_snippets": "Alanine aminotransferase (ALT) ... ≤ 2.5 x ULN (≤ 5 x ULN for subjects with liver metastases)",
                    "criterion": "liver metastases",
                    "requirement": {
                        "requirement_type": "presence",
                        "expected_value": true
                    }
                },
                "then_criteria": {
                    "and_criteria": [
                        {
                            "exact_snippets": "Alanine aminotransferase (ALT) ... ≤ 2.5 x ULN (≤ 5 x ULN for subjects with liver metastases)",
                            "criterion": "Alanine aminotransferase (ALT)",
                            "requirement": {
                                "requirement_type": "level with liver metastases",
                                "expected_value": {
                                    "comparisons": [
                                        {
                                            "operator": "<=",
                                            "value": 5,
                                            "unit": "x ULN"
                                        }
                                    ]
                                }
                            }
                        },
                        {
                            "exact_snippets": "aspartate aminotransferase (AST) ≤ 2.5 x ULN (≤ 5 x ULN for subjects with liver metastases)",
                            "criterion": "aspartate aminotransferase (AST)",
                            "requirement": {
                                "requirement_type": "level with liver metastases",
                                "expected_value": {
                                    "comparisons": [
                                        {
                                            "operator": "<=",
                                            "value": 5,
                                            "unit": "x ULN"
                                        }
                                    ]
                                }
                            }
                        }
                    ]
                },
                "else_criteria": {
                    "and_criteria": [
                        {
                            "exact_snippets": "Alanine aminotransferase (ALT) ... ≤ 2.5 x ULN (≤ 5 x ULN for subjects with liver metastases)",
                            "criterion": "Alanine aminotransferase (ALT)",
                            "requirement": {
                                "requirement_type": "level",
                                "expected_value": {
                                    "comparisons": [
                                        {
                                            "operator": "<=",
                                            "value": 2.5,
                                            "unit": "x ULN"
                                        }
                                    ]
                                }
                            }
                        },
                        {
                            "exact_snippets": "aspartate aminotransferase (AST) ≤ 2.5 x ULN (≤ 5 x ULN for subjects with liver metastases)",
                            "criterion": "aspartate aminotransferase (AST)",
                            "requirement": {
                                "requirement_type": "level",
                                "expected_value": {
                                    "comparisons": [
                                        {
                                            "operator": "<=",
                                            "value": 2.5,
                                            "unit": "x ULN"
                                        }
                                    ]
                                }
                            }
                        }
                    ]
                }
            }
        },
        {
            "identified_line": {
                "line": "* Albumin ≥2.5mg/dL",
                "criterions": [
                    {
                        "exact_snippets": "Albumin ≥2.5mg/dL",
                        "criterion": "albumin level",
                        "requirement": {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2.5,
                                "unit": "mg/dL"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Albumin ≥2.5mg/dL",
                        "criterion": "albumin level",
                        "requirement": {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2.5,
                                "unit": "mg/dL"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* International Normalized Ratio (INR) or PT/aPTT <1.5 x ULN. For subjects receiving anticoagulation therapy, PT/aPTT and INR should not be greater than the recommended range for the intended use of the anticoagulant",
                "criterions": [
                    {
                        "exact_snippets": "International Normalized Ratio (INR) ... <1.5 x ULN",
                        "criterion": "International Normalized Ratio (INR)",
                        "requirement": {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": "<",
                                "value": 1.5,
                                "unit": "x ULN"
                            }
                        }
                    },
                    {
                        "exact_snippets": "PT/aPTT <1.5 x ULN",
                        "criterion": "PT/aPTT",
                        "requirement": {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": "<",
                                "value": 1.5,
                                "unit": "x ULN"
                            }
                        }
                    },
                    {
                        "exact_snippets": "subjects receiving anticoagulation therapy, PT/aPTT and INR should not be greater than the recommended range for the intended use of the anticoagulant",
                        "criterion": "anticoagulation therapy",
                        "requirement": {
                            "requirement_type": "value",
                            "expected_value": "PT/aPTT and INR should not be greater than the recommended range for the intended use of the anticoagulant"
                        }
                    }
                ]
            },
            "logical_structure": {
                "condition": {
                    "exact_snippets": "subjects receiving anticoagulation therapy, PT/aPTT and INR should not be greater than the recommended range for the intended use of the anticoagulant",
                    "criterion": "anticoagulation therapy",
                    "requirement": {
                        "requirement_type": "value",
                        "expected_value": "PT/aPTT and INR should not be greater than the recommended range for the intended use of the anticoagulant"
                    }
                },
                "then_criteria": null,
                "else_criteria": {
                    "and_criteria": [
                        {
                            "exact_snippets": "International Normalized Ratio (INR) ... <1.5 x ULN",
                            "criterion": "International Normalized Ratio (INR)",
                            "requirement": {
                                "requirement_type": "value",
                                "expected_value": {
                                    "operator": "<",
                                    "value": 1.5,
                                    "unit": "x ULN"
                                }
                            }
                        },
                        {
                            "exact_snippets": "PT/aPTT <1.5 x ULN",
                            "criterion": "PT/aPTT",
                            "requirement": {
                                "requirement_type": "value",
                                "expected_value": {
                                    "operator": "<",
                                    "value": 1.5,
                                    "unit": "x ULN"
                                }
                            }
                        }
                    ]
                }
            }
        },
        {
            "identified_line": {
                "line": "11. Have recovered from the effects of any prior radiotherapy or surgery;",
                "criterions": [
                    {
                        "exact_snippets": "recovered from the effects of any prior radiotherapy",
                        "criterion": "recovery from prior radiotherapy",
                        "requirement": {
                            "requirement_type": "recovery",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "recovered from the effects of any prior ... surgery",
                        "criterion": "recovery from prior surgery",
                        "requirement": {
                            "requirement_type": "recovery",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "recovered from the effects of any prior radiotherapy",
                        "criterion": "recovery from prior radiotherapy",
                        "requirement": {
                            "requirement_type": "recovery",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "recovered from the effects of any prior ... surgery",
                        "criterion": "recovery from prior surgery",
                        "requirement": {
                            "requirement_type": "recovery",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "13. All female and male subjects of reproductive potential must agree to use an effective method of contraception, as determined by the Investigator, during and for 4 months after the last dose of study treatment.",
                "criterions": [
                    {
                        "exact_snippets": "All female and male subjects of reproductive potential",
                        "criterion": "reproductive potential",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "must agree to use an effective method of contraception",
                        "criterion": "contraception use",
                        "requirement": {
                            "requirement_type": "agreement",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "during and for 4 months after the last dose of study treatment",
                        "criterion": "contraception duration",
                        "requirement": {
                            "requirement_type": "duration",
                            "expected_value": "during and for 4 months after the last dose of study treatment"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "All female and male subjects of reproductive potential",
                                "criterion": "reproductive potential",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": true
                                }
                            },
                            {
                                "exact_snippets": "must agree to use an effective method of contraception",
                                "criterion": "contraception use",
                                "requirement": {
                                    "requirement_type": "agreement",
                                    "expected_value": true
                                }
                            }
                        ]
                    },
                    {
                        "exact_snippets": "during and for 4 months after the last dose of study treatment",
                        "criterion": "contraception duration",
                        "requirement": {
                            "requirement_type": "duration",
                            "expected_value": "during and for 4 months after the last dose of study treatment"
                        }
                    }
                ]
            }
        },
        {
            "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"
                            }
                        }
                    }
                ]
            }
        }
    ],
    "exclusion_lines": [
        {
            "identified_line": {
                "line": "2. Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy > 10 mg prednisone or equivalent per day or any other form of immunosuppressive therapy within 7 days prior to the first dose of study treatment;",
                "criterions": [
                    {
                        "exact_snippets": "Has a diagnosis of immunodeficiency",
                        "criterion": "immunodeficiency",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "receiving systemic steroid therapy > 10 mg prednisone or equivalent per day",
                        "criterion": "systemic steroid therapy",
                        "requirement": {
                            "requirement_type": "dosage",
                            "expected_value": {
                                "operator": ">",
                                "value": 10,
                                "unit": "mg prednisone or equivalent per day"
                            }
                        }
                    },
                    {
                        "exact_snippets": "any other form of immunosuppressive therapy within 7 days prior to the first dose of study treatment",
                        "criterion": "immunosuppressive therapy",
                        "requirement": {
                            "requirement_type": "timing",
                            "expected_value": "within 7 days prior to the first dose of study treatment"
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "exact_snippets": "Has a diagnosis of immunodeficiency",
                        "criterion": "immunodeficiency",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "receiving systemic steroid therapy > 10 mg prednisone or equivalent per day",
                        "criterion": "systemic steroid therapy",
                        "requirement": {
                            "requirement_type": "dosage",
                            "expected_value": {
                                "operator": ">",
                                "value": 10,
                                "unit": "mg prednisone or equivalent per day"
                            }
                        }
                    },
                    {
                        "exact_snippets": "any other form of immunosuppressive therapy within 7 days prior to the first dose of study treatment",
                        "criterion": "immunosuppressive therapy",
                        "requirement": {
                            "requirement_type": "timing",
                            "expected_value": "within 7 days prior to the first dose of study treatment"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "3. Has undergone major surgery within 3 weeks of Study Day 1, Subject must have recovered adequately from any toxicity and/or complications from the intervention prior to starting therapy;",
                "criterions": [
                    {
                        "exact_snippets": "Has undergone major surgery within 3 weeks of Study Day 1",
                        "criterion": "major surgery",
                        "requirement": {
                            "requirement_type": "time since surgery",
                            "expected_value": {
                                "operator": "<=",
                                "value": 3,
                                "unit": "weeks"
                            }
                        }
                    },
                    {
                        "exact_snippets": "Subject must have recovered adequately from any toxicity and/or complications from the intervention",
                        "criterion": "recovery from surgery",
                        "requirement": {
                            "requirement_type": "recovery status",
                            "expected_value": "adequate"
                        }
                    }
                ]
            },
            "logical_structure": {
                "condition": {
                    "exact_snippets": "Has undergone major surgery within 3 weeks of Study Day 1",
                    "criterion": "major surgery",
                    "requirement": {
                        "requirement_type": "time since surgery",
                        "expected_value": {
                            "operator": "<=",
                            "value": 3,
                            "unit": "weeks"
                        }
                    }
                },
                "then_criteria": {
                    "not_criteria": {
                        "exact_snippets": "Subject must have recovered adequately from any toxicity and/or complications from the intervention",
                        "criterion": "recovery from surgery",
                        "requirement": {
                            "requirement_type": "recovery status",
                            "expected_value": "adequate"
                        }
                    }
                },
                "else_criteria": null
            }
        },
        {
            "identified_line": {
                "line": "4. Has a known additional malignancy that is progressing or requires systemic treatment. Exceptions include basal cell carcinoma of the skin, squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer.",
                "criterions": [
                    {
                        "exact_snippets": "Has a known additional malignancy that is progressing or requires systemic treatment.",
                        "criterion": "additional malignancy",
                        "requirement": {
                            "requirement_type": "progression",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Has a known additional malignancy that is progressing or requires systemic treatment.",
                        "criterion": "additional malignancy",
                        "requirement": {
                            "requirement_type": "systemic treatment requirement",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Exceptions include basal cell carcinoma of the skin",
                        "criterion": "basal cell carcinoma of the skin",
                        "requirement": {
                            "requirement_type": "exception",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Exceptions include ... squamous cell carcinoma of the skin that has undergone potentially curative therapy",
                        "criterion": "squamous cell carcinoma of the skin",
                        "requirement": {
                            "requirement_type": "curative therapy",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Exceptions include ... in situ cervical cancer",
                        "criterion": "in situ cervical cancer",
                        "requirement": {
                            "requirement_type": "exception",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "condition": {
                    "and_criteria": [
                        {
                            "or_criteria": [
                                {
                                    "exact_snippets": "Has a known additional malignancy that is progressing or requires systemic treatment.",
                                    "criterion": "additional malignancy",
                                    "requirement": {
                                        "requirement_type": "progression",
                                        "expected_value": true
                                    }
                                },
                                {
                                    "exact_snippets": "Has a known additional malignancy that is progressing or requires systemic treatment.",
                                    "criterion": "additional malignancy",
                                    "requirement": {
                                        "requirement_type": "systemic treatment requirement",
                                        "expected_value": true
                                    }
                                }
                            ]
                        }
                    ]
                },
                "then_criteria": {
                    "not_criteria": {
                        "or_criteria": [
                            {
                                "exact_snippets": "Exceptions include basal cell carcinoma of the skin",
                                "criterion": "basal cell carcinoma of the skin",
                                "requirement": {
                                    "requirement_type": "exception",
                                    "expected_value": true
                                }
                            },
                            {
                                "and_criteria": [
                                    {
                                        "exact_snippets": "Exceptions include ... squamous cell carcinoma of the skin that has undergone potentially curative therapy",
                                        "criterion": "squamous cell carcinoma of the skin",
                                        "requirement": {
                                            "requirement_type": "curative therapy",
                                            "expected_value": true
                                        }
                                    }
                                ]
                            },
                            {
                                "exact_snippets": "Exceptions include ... in situ cervical cancer",
                                "criterion": "in situ cervical cancer",
                                "requirement": {
                                    "requirement_type": "exception",
                                    "expected_value": true
                                }
                            }
                        ]
                    }
                },
                "else_criteria": null
            }
        },
        {
            "identified_line": {
                "line": "5. Has received transfusion of blood products (including platelets or red blood cells) or administration of colony stimulating factors (including granulocyte colony-stimulating factor [G-CSF], GM-CSF or recombinant erythropoietin) within 4 weeks prior to study Day 1;",
                "criterions": [
                    {
                        "exact_snippets": "Has received transfusion of blood products (including platelets or red blood cells)",
                        "criterion": "transfusion of blood products",
                        "requirement": {
                            "requirement_type": "time frame",
                            "expected_value": "within 4 weeks prior to study Day 1"
                        }
                    },
                    {
                        "exact_snippets": "administration of colony stimulating factors (including granulocyte colony-stimulating factor [G-CSF], GM-CSF or recombinant erythropoietin)",
                        "criterion": "administration of colony stimulating factors",
                        "requirement": {
                            "requirement_type": "time frame",
                            "expected_value": "within 4 weeks prior to study Day 1"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Has received transfusion of blood products (including platelets or red blood cells)",
                                "criterion": "transfusion of blood products",
                                "requirement": {
                                    "requirement_type": "time frame",
                                    "expected_value": "within 4 weeks prior to study Day 1"
                                }
                            },
                            {
                                "exact_snippets": "administration of colony stimulating factors (including granulocyte colony-stimulating factor [G-CSF], GM-CSF or recombinant erythropoietin)",
                                "criterion": "administration of colony stimulating factors",
                                "requirement": {
                                    "requirement_type": "time frame",
                                    "expected_value": "within 4 weeks prior to study Day 1"
                                }
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "6. Has known active central nervous system (CNS) metastases NOTE: Subjects with previously treated brain metastases may participate provided they are stable (without evidence of progression by imaging [using the identical imaging modality for each assessment, either magnetic resonance imaging (MRI) or computerized tomography (CT) scan] for at least four weeks prior to the first dose of study treatment and any neurologic symptoms have returned to baseline), have no evidence of new or enlarging brain metastases, and are not using steroids for at least 7 days prior to study treatment;",
                "criterions": [
                    {
                        "exact_snippets": "Has known active central nervous system (CNS) metastases",
                        "criterion": "active CNS metastases",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "Subjects with previously treated brain metastases may participate provided they are stable ... for at least four weeks prior to the first dose of study treatment",
                        "criterion": "stability of previously treated brain metastases",
                        "requirement": {
                            "requirement_type": "duration of stability",
                            "expected_value": {
                                "operator": ">=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    },
                    {
                        "exact_snippets": "any neurologic symptoms have returned to baseline",
                        "criterion": "neurologic symptoms",
                        "requirement": {
                            "requirement_type": "severity",
                            "expected_value": "baseline"
                        }
                    },
                    {
                        "exact_snippets": "have no evidence of new or enlarging brain metastases",
                        "criterion": "new or enlarging brain metastases",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "are not using steroids for at least 7 days prior to study treatment",
                        "criterion": "steroid use",
                        "requirement": {
                            "requirement_type": "duration of non-use",
                            "expected_value": {
                                "operator": ">=",
                                "value": 7,
                                "unit": "days"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "condition": {
                    "exact_snippets": "Has known active central nervous system (CNS) metastases",
                    "criterion": "active CNS metastases",
                    "requirement": {
                        "requirement_type": "presence",
                        "expected_value": false
                    }
                },
                "then_criteria": {
                    "or_criteria": [
                        {
                            "and_criteria": [
                                {
                                    "exact_snippets": "Subjects with previously treated brain metastases may participate provided they are stable ... for at least four weeks prior to the first dose of study treatment",
                                    "criterion": "stability of previously treated brain metastases",
                                    "requirement": {
                                        "requirement_type": "duration of stability",
                                        "expected_value": {
                                            "operator": ">=",
                                            "value": 4,
                                            "unit": "weeks"
                                        }
                                    }
                                },
                                {
                                    "exact_snippets": "any neurologic symptoms have returned to baseline",
                                    "criterion": "neurologic symptoms",
                                    "requirement": {
                                        "requirement_type": "severity",
                                        "expected_value": "baseline"
                                    }
                                },
                                {
                                    "exact_snippets": "have no evidence of new or enlarging brain metastases",
                                    "criterion": "new or enlarging brain metastases",
                                    "requirement": {
                                        "requirement_type": "presence",
                                        "expected_value": false
                                    }
                                },
                                {
                                    "exact_snippets": "are not using steroids for at least 7 days prior to study treatment",
                                    "criterion": "steroid use",
                                    "requirement": {
                                        "requirement_type": "duration of non-use",
                                        "expected_value": {
                                            "operator": ">=",
                                            "value": 7,
                                            "unit": "days"
                                        }
                                    }
                                }
                            ]
                        }
                    ]
                },
                "else_criteria": null
            }
        },
        {
            "identified_line": {
                "line": "7. Has carcinomatous meningitis;",
                "criterions": [
                    {
                        "exact_snippets": "Has carcinomatous meningitis",
                        "criterion": "carcinomatous meningitis",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Has carcinomatous meningitis",
                        "criterion": "carcinomatous meningitis",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "9. Has history of interstitial lung disease, or history of (non-infectious) pneumonitis that required steroids, or current pneumonitis;",
                "criterions": [
                    {
                        "exact_snippets": "history of interstitial lung disease",
                        "criterion": "interstitial lung disease",
                        "requirement": {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "history of (non-infectious) pneumonitis that required steroids",
                        "criterion": "non-infectious pneumonitis",
                        "requirement": {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "history of (non-infectious) pneumonitis that required steroids",
                        "criterion": "non-infectious pneumonitis",
                        "requirement": {
                            "requirement_type": "treatment",
                            "expected_value": "steroids"
                        }
                    },
                    {
                        "exact_snippets": "current pneumonitis",
                        "criterion": "pneumonitis",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "history of interstitial lung disease",
                                "criterion": "interstitial lung disease",
                                "requirement": {
                                    "requirement_type": "history",
                                    "expected_value": true
                                }
                            }
                        ]
                    },
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "history of (non-infectious) pneumonitis that required steroids",
                                "criterion": "non-infectious pneumonitis",
                                "requirement": {
                                    "requirement_type": "history",
                                    "expected_value": true
                                }
                            },
                            {
                                "exact_snippets": "history of (non-infectious) pneumonitis that required steroids",
                                "criterion": "non-infectious pneumonitis",
                                "requirement": {
                                    "requirement_type": "treatment",
                                    "expected_value": "steroids"
                                }
                            }
                        ]
                    },
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "current pneumonitis",
                                "criterion": "pneumonitis",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": true
                                }
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "10. Has an active infection requiring systemic therapy NOTE: Antibiotic therapy must have been completed a minimum of 3 days prior to start of study treatment;",
                "criterions": [
                    {
                        "exact_snippets": "active infection requiring systemic therapy",
                        "criterion": "active infection",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "Antibiotic therapy must have been completed a minimum of 3 days prior to start of study treatment",
                        "criterion": "antibiotic therapy completion",
                        "requirement": {
                            "requirement_type": "time since completion",
                            "expected_value": {
                                "operator": ">=",
                                "value": 3,
                                "unit": "days"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "condition": {
                    "exact_snippets": "active infection requiring systemic therapy",
                    "criterion": "active infection",
                    "requirement": {
                        "requirement_type": "presence",
                        "expected_value": false
                    }
                },
                "then_criteria": {
                    "exact_snippets": "Antibiotic therapy must have been completed a minimum of 3 days prior to start of study treatment",
                    "criterion": "antibiotic therapy completion",
                    "requirement": {
                        "requirement_type": "time since completion",
                        "expected_value": {
                            "operator": ">=",
                            "value": 3,
                            "unit": "days"
                        }
                    }
                },
                "else_criteria": null
            }
        },
        {
            "identified_line": {
                "line": "11. Has known active Hepatitis B (e.g., HBsAg reactive) or Hepatitis C (e.g., HCV RNA [qualitative] is detected);",
                "criterions": [
                    {
                        "exact_snippets": "Has known active Hepatitis B (e.g., HBsAg reactive)",
                        "criterion": "Hepatitis B",
                        "requirement": {
                            "requirement_type": "activity",
                            "expected_value": "active"
                        }
                    },
                    {
                        "exact_snippets": "Has known active ... Hepatitis C (e.g., HCV RNA [qualitative] is detected)",
                        "criterion": "Hepatitis C",
                        "requirement": {
                            "requirement_type": "activity",
                            "expected_value": "active"
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "exact_snippets": "Has known active Hepatitis B (e.g., HBsAg reactive)",
                        "criterion": "Hepatitis B",
                        "requirement": {
                            "requirement_type": "activity",
                            "expected_value": "active"
                        }
                    },
                    {
                        "exact_snippets": "Has known active ... Hepatitis C (e.g., HCV RNA [qualitative] is detected)",
                        "criterion": "Hepatitis C",
                        "requirement": {
                            "requirement_type": "activity",
                            "expected_value": "active"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "12. History of myocardial infarction, unstable angina, cardiac or other vascular stenting, angioplasty, or surgery within 6 months prior to day 1 of study treatment;",
                "criterions": [
                    {
                        "exact_snippets": "History of myocardial infarction",
                        "criterion": "myocardial infarction",
                        "requirement": {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "History of myocardial infarction",
                        "criterion": "myocardial infarction",
                        "requirement": {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 6,
                                        "unit": "months"
                                    }
                                ]
                            }
                        }
                    },
                    {
                        "exact_snippets": "History of ... unstable angina",
                        "criterion": "unstable angina",
                        "requirement": {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "History of ... unstable angina",
                        "criterion": "unstable angina",
                        "requirement": {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 6,
                                        "unit": "months"
                                    }
                                ]
                            }
                        }
                    },
                    {
                        "exact_snippets": "History of ... cardiac or other vascular stenting",
                        "criterion": "cardiac or other vascular stenting",
                        "requirement": {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "History of ... cardiac or other vascular stenting",
                        "criterion": "cardiac or other vascular stenting",
                        "requirement": {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 6,
                                        "unit": "months"
                                    }
                                ]
                            }
                        }
                    },
                    {
                        "exact_snippets": "History of ... angioplasty",
                        "criterion": "angioplasty",
                        "requirement": {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "History of ... angioplasty",
                        "criterion": "angioplasty",
                        "requirement": {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 6,
                                        "unit": "months"
                                    }
                                ]
                            }
                        }
                    },
                    {
                        "exact_snippets": "History of ... surgery",
                        "criterion": "surgery",
                        "requirement": {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "History of ... surgery",
                        "criterion": "surgery",
                        "requirement": {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 6,
                                        "unit": "months"
                                    }
                                ]
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "History of myocardial infarction",
                                "criterion": "myocardial infarction",
                                "requirement": {
                                    "requirement_type": "history",
                                    "expected_value": true
                                }
                            },
                            {
                                "exact_snippets": "History of myocardial infarction",
                                "criterion": "myocardial infarction",
                                "requirement": {
                                    "requirement_type": "time frame",
                                    "expected_value": {
                                        "comparisons": [
                                            {
                                                "operator": "<=",
                                                "value": 6,
                                                "unit": "months"
                                            }
                                        ]
                                    }
                                }
                            }
                        ]
                    },
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "History of ... unstable angina",
                                "criterion": "unstable angina",
                                "requirement": {
                                    "requirement_type": "history",
                                    "expected_value": true
                                }
                            },
                            {
                                "exact_snippets": "History of ... unstable angina",
                                "criterion": "unstable angina",
                                "requirement": {
                                    "requirement_type": "time frame",
                                    "expected_value": {
                                        "comparisons": [
                                            {
                                                "operator": "<=",
                                                "value": 6,
                                                "unit": "months"
                                            }
                                        ]
                                    }
                                }
                            }
                        ]
                    },
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "History of ... cardiac or other vascular stenting",
                                "criterion": "cardiac or other vascular stenting",
                                "requirement": {
                                    "requirement_type": "history",
                                    "expected_value": true
                                }
                            },
                            {
                                "exact_snippets": "History of ... cardiac or other vascular stenting",
                                "criterion": "cardiac or other vascular stenting",
                                "requirement": {
                                    "requirement_type": "time frame",
                                    "expected_value": {
                                        "comparisons": [
                                            {
                                                "operator": "<=",
                                                "value": 6,
                                                "unit": "months"
                                            }
                                        ]
                                    }
                                }
                            }
                        ]
                    },
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "History of ... angioplasty",
                                "criterion": "angioplasty",
                                "requirement": {
                                    "requirement_type": "history",
                                    "expected_value": true
                                }
                            },
                            {
                                "exact_snippets": "History of ... angioplasty",
                                "criterion": "angioplasty",
                                "requirement": {
                                    "requirement_type": "time frame",
                                    "expected_value": {
                                        "comparisons": [
                                            {
                                                "operator": "<=",
                                                "value": 6,
                                                "unit": "months"
                                            }
                                        ]
                                    }
                                }
                            }
                        ]
                    },
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "History of ... surgery",
                                "criterion": "surgery",
                                "requirement": {
                                    "requirement_type": "history",
                                    "expected_value": true
                                }
                            },
                            {
                                "exact_snippets": "History of ... surgery",
                                "criterion": "surgery",
                                "requirement": {
                                    "requirement_type": "time frame",
                                    "expected_value": {
                                        "comparisons": [
                                            {
                                                "operator": "<=",
                                                "value": 6,
                                                "unit": "months"
                                            }
                                        ]
                                    }
                                }
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "13. Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the subject's participation for the full duration of the study, or is not in the best interest of this subject to participate, in the opinion of the treating investigator;",
                "criterions": [
                    {
                        "exact_snippets": "Has a history or current evidence of any condition",
                        "criterion": "condition",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "therapy",
                        "criterion": "therapy",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "laboratory abnormality",
                        "criterion": "laboratory abnormality",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Has a history or current evidence of any condition",
                                "criterion": "condition",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": true
                                }
                            },
                            {
                                "exact_snippets": "therapy",
                                "criterion": "therapy",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": true
                                }
                            },
                            {
                                "exact_snippets": "laboratory abnormality",
                                "criterion": "laboratory abnormality",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": true
                                }
                            }
                        ]
                    },
                    {
                        "exact_snippets": "Has a history or current evidence of any condition",
                        "criterion": "condition",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "therapy",
                        "criterion": "therapy",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "laboratory abnormality",
                        "criterion": "laboratory abnormality",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "14. Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the study;",
                "criterions": [
                    {
                        "exact_snippets": "known psychiatric or substance abuse disorders",
                        "criterion": "psychiatric disorders",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "known psychiatric or substance abuse disorders",
                        "criterion": "substance abuse disorders",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "exact_snippets": "known psychiatric or substance abuse disorders",
                        "criterion": "psychiatric disorders",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "known psychiatric or substance abuse disorders",
                        "criterion": "substance abuse disorders",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "16. Is pregnant, breastfeeding, or expecting to conceive or father a child within the projected duration of the study including 120 days following the last dose of study treatment; or",
                "criterions": [
                    {
                        "exact_snippets": "Is pregnant",
                        "criterion": "pregnancy status",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "breastfeeding",
                        "criterion": "breastfeeding status",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "expecting to conceive",
                        "criterion": "intention to conceive",
                        "requirement": {
                            "requirement_type": "intention",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "father a child",
                        "criterion": "intention to father a child",
                        "requirement": {
                            "requirement_type": "intention",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "within the projected duration of the study including 120 days following the last dose of study treatment",
                        "criterion": "timeframe for conception or fathering a child",
                        "requirement": {
                            "requirement_type": "timeframe",
                            "expected_value": "within the projected duration of the study including 120 days following the last dose of study treatment"
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Is pregnant",
                                "criterion": "pregnancy status",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": true
                                }
                            }
                        ]
                    },
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "breastfeeding",
                                "criterion": "breastfeeding status",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": true
                                }
                            }
                        ]
                    },
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "expecting to conceive",
                                "criterion": "intention to conceive",
                                "requirement": {
                                    "requirement_type": "intention",
                                    "expected_value": true
                                }
                            },
                            {
                                "exact_snippets": "within the projected duration of the study including 120 days following the last dose of study treatment",
                                "criterion": "timeframe for conception or fathering a child",
                                "requirement": {
                                    "requirement_type": "timeframe",
                                    "expected_value": "within the projected duration of the study including 120 days following the last dose of study treatment"
                                }
                            }
                        ]
                    },
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "father a child",
                                "criterion": "intention to father a child",
                                "requirement": {
                                    "requirement_type": "intention",
                                    "expected_value": true
                                }
                            },
                            {
                                "exact_snippets": "within the projected duration of the study including 120 days following the last dose of study treatment",
                                "criterion": "timeframe for conception or fathering a child",
                                "requirement": {
                                    "requirement_type": "timeframe",
                                    "expected_value": "within the projected duration of the study including 120 days following the last dose of study treatment"
                                }
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "17. Has any concurrent medical condition that, in the opinion of the Investigator, would complicate or compromise compliance with the study or the well-being of the subject.",
                "criterions": [
                    {
                        "exact_snippets": "Has any concurrent medical condition",
                        "criterion": "concurrent medical condition",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "in the opinion of the Investigator, would complicate or compromise compliance with the study",
                        "criterion": "complication or compromise of compliance with the study",
                        "requirement": {
                            "requirement_type": "opinion",
                            "expected_value": "Investigator"
                        }
                    },
                    {
                        "exact_snippets": "in the opinion of the Investigator, would complicate or compromise ... the well-being of the subject",
                        "criterion": "complication or compromise of well-being of the subject",
                        "requirement": {
                            "requirement_type": "opinion",
                            "expected_value": "Investigator"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Has any concurrent medical condition",
                                "criterion": "concurrent medical condition",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": true
                                }
                            },
                            {
                                "exact_snippets": "in the opinion of the Investigator, would complicate or compromise compliance with the study",
                                "criterion": "complication or compromise of compliance with the study",
                                "requirement": {
                                    "requirement_type": "opinion",
                                    "expected_value": "Investigator"
                                }
                            }
                        ]
                    },
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Has any concurrent medical condition",
                                "criterion": "concurrent medical condition",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": true
                                }
                            },
                            {
                                "exact_snippets": "in the opinion of the Investigator, would complicate or compromise ... the well-being of the subject",
                                "criterion": "complication or compromise of well-being of the subject",
                                "requirement": {
                                    "requirement_type": "opinion",
                                    "expected_value": "Investigator"
                                }
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "18. Have an EGFR or ALK genomic tumor aberrations for which targeted therapy with an EGFR or ALK inhibitor is indicated.",
                "criterions": [
                    {
                        "exact_snippets": "Have an EGFR ... genomic tumor aberrations",
                        "criterion": "EGFR genomic tumor aberrations",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Have an ... ALK genomic tumor aberrations",
                        "criterion": "ALK genomic tumor aberrations",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "for which targeted therapy with an EGFR ... inhibitor is indicated",
                        "criterion": "EGFR inhibitor therapy indication",
                        "requirement": {
                            "requirement_type": "indication",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "for which targeted therapy with an ... ALK inhibitor is indicated",
                        "criterion": "ALK inhibitor therapy indication",
                        "requirement": {
                            "requirement_type": "indication",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Have an EGFR ... genomic tumor aberrations",
                                "criterion": "EGFR genomic tumor aberrations",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": true
                                }
                            },
                            {
                                "exact_snippets": "for which targeted therapy with an EGFR ... inhibitor is indicated",
                                "criterion": "EGFR inhibitor therapy indication",
                                "requirement": {
                                    "requirement_type": "indication",
                                    "expected_value": true
                                }
                            }
                        ]
                    },
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Have an ... ALK genomic tumor aberrations",
                                "criterion": "ALK genomic tumor aberrations",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": true
                                }
                            },
                            {
                                "exact_snippets": "for which targeted therapy with an ... ALK inhibitor is indicated",
                                "criterion": "ALK inhibitor therapy indication",
                                "requirement": {
                                    "requirement_type": "indication",
                                    "expected_value": true
                                }
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "19. Has had prior treatment with an anti-PD-1 or anti-PD-L1 antibody, anti-cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4) antibody (including ipilimumab) or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways;",
                "criterions": [
                    {
                        "exact_snippets": "prior treatment with an anti-PD-1 or anti-PD-L1 antibody",
                        "criterion": "prior treatment with anti-PD-1 or anti-PD-L1 antibody",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "prior treatment with ... anti-cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4) antibody (including ipilimumab)",
                        "criterion": "prior treatment with anti-CTLA-4 antibody",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "prior treatment with ... any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways",
                        "criterion": "prior treatment with antibody or drug targeting T-cell co-stimulation or checkpoint pathways",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "prior treatment with an anti-PD-1 or anti-PD-L1 antibody",
                                "criterion": "prior treatment with anti-PD-1 or anti-PD-L1 antibody",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": true
                                }
                            }
                        ]
                    },
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "prior treatment with ... anti-cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4) antibody (including ipilimumab)",
                                "criterion": "prior treatment with anti-CTLA-4 antibody",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": true
                                }
                            }
                        ]
                    },
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "prior treatment with ... any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways",
                                "criterion": "prior treatment with antibody or drug targeting T-cell co-stimulation or checkpoint pathways",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": true
                                }
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "Additional Exclusion Criteria for Cohort 2:",
                "criterions": []
            },
            "logical_structure": {
                "and_criteria": []
            }
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [
        {
            "identified_line": {
                "line": "* Serum creatinine ≤ 1.5 x Upper Limit of Normal (ULN) OR",
                "criterions": [
                    {
                        "exact_snippets": "Serum creatinine ≤ 1.5 x Upper Limit of Normal (ULN)",
                        "criterion": "serum creatinine",
                        "requirement": {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "x ULN"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "exact_snippets": "Serum creatinine \u0010.5 x Upper Limit of Normal (ULN)",
                        "criterion": "serum creatinine",
                        "requirement": {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "x ULN"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Serum total bilirubin ≤ 1.5 x ULN OR",
                "criterions": [
                    {
                        "exact_snippets": "Serum total bilirubin ≤ 1.5 x ULN",
                        "criterion": "serum total bilirubin",
                        "requirement": {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "x ULN"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "exact_snippets": "Serum total bilirubin \u0010.5 x ULN",
                        "criterion": "serum total bilirubin",
                        "requirement": {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "x ULN"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "12. Female subjects of childbearing potential must have a negative serum human chorionic gonadotropic (hCG) test within 1 week of Day 1 (pregnancy test not required for subjects with bilateral oophorectomy and/or hysterectomy or for those subjects who are >1 year post-menopausal); and",
                "criterions": [
                    {
                        "exact_snippets": "Female subjects of childbearing potential",
                        "criterion": "gender and reproductive potential",
                        "requirement": {
                            "requirement_type": "gender",
                            "expected_value": "female"
                        }
                    },
                    {
                        "exact_snippets": "Female subjects of childbearing potential",
                        "criterion": "gender and reproductive potential",
                        "requirement": {
                            "requirement_type": "reproductive potential",
                            "expected_value": "childbearing potential"
                        }
                    },
                    {
                        "exact_snippets": "negative serum human chorionic gonadotropic (hCG) test",
                        "criterion": "serum hCG test result",
                        "requirement": {
                            "requirement_type": "result",
                            "expected_value": "negative"
                        }
                    },
                    {
                        "exact_snippets": "within 1 week of Day 1",
                        "criterion": "timing of serum hCG test",
                        "requirement": {
                            "requirement_type": "timing",
                            "expected_value": "within 1 week of Day 1"
                        }
                    },
                    {
                        "exact_snippets": "pregnancy test not required for subjects with bilateral oophorectomy and/or hysterectomy",
                        "criterion": "surgical history",
                        "requirement": {
                            "requirement_type": "surgery",
                            "expected_value": [
                                "bilateral oophorectomy",
                                "hysterectomy"
                            ]
                        }
                    },
                    {
                        "exact_snippets": "pregnancy test not required ... for those subjects who are >1 year post-menopausal",
                        "criterion": "menopausal status",
                        "requirement": {
                            "requirement_type": "post-menopausal duration",
                            "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. Is currently participating in or has participated in a study of an investigational agent or using an investigational device within 14 days of the first dose of treatment;",
                "criterions": [
                    {
                        "exact_snippets": "Is 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": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "using an investigational device within 14 days of the first dose of treatment",
                        "criterion": "use of an investigational device",
                        "requirement": {
                            "requirement_type": "time since last use",
                            "expected_value": {
                                "operator": "<=",
                                "value": 14,
                                "unit": "days"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Is 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": "presence",
                                    "expected_value": true
                                }
                            }
                        ]
                    },
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "using an investigational device within 14 days of the first dose of treatment",
                                "criterion": "use of an investigational device",
                                "requirement": {
                                    "requirement_type": "time since last use",
                                    "expected_value": {
                                        "operator": "<=",
                                        "value": 14,
                                        "unit": "days"
                                    }
                                }
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "8. Has an active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment NOTE: Subjects with vitiligo or resolved childhood asthma/atopy would be an exception to this rule. Subjects that require intermittent use of bronchodilators or local steroid injections would not be excluded from the study;",
                "criterions": [
                    {
                        "exact_snippets": "Has an active autoimmune disease",
                        "criterion": "active autoimmune disease",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "has required systemic treatment in the past 2 years",
                        "criterion": "systemic treatment for autoimmune disease",
                        "requirement": {
                            "requirement_type": "time frame",
                            "expected_value": "past 2 years"
                        }
                    },
                    {
                        "exact_snippets": "Replacement therapy (e.g., thyroxine, insulin or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment",
                        "criterion": "replacement therapy",
                        "requirement": {
                            "requirement_type": "consideration as systemic treatment",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "Subjects with vitiligo or resolved childhood asthma/atopy would be an exception to this rule",
                        "criterion": "vitiligo or resolved childhood asthma/atopy",
                        "requirement": {
                            "requirement_type": "exception",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Subjects that require intermittent use of bronchodilators or local steroid injections would not be excluded from the study",
                        "criterion": "intermittent use of bronchodilators or local steroid injections",
                        "requirement": {
                            "requirement_type": "exclusion",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "exact_snippets": "failed",
                "criterion": "failed",
                "requirement": {
                    "requirement_type": "failed",
                    "expected_value": "failed"
                }
            }
        },
        {
            "identified_line": {
                "line": "15. Has received a live virus vaccine within 30 days of the planned first dose of study therapy NOTE: seasonal influenza vaccines for injection which are generally inactivated flu vaccines are permitted; however, intranasal influenza vaccines (e.g., Flu-Mist®) are live attenuated vaccines and are not permitted;",
                "criterions": [
                    {
                        "exact_snippets": "Has received a live virus vaccine within 30 days of the planned first dose of study therapy",
                        "criterion": "live virus vaccine",
                        "requirement": {
                            "requirement_type": "receipt",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "Has received a live virus vaccine within 30 days of the planned first dose of study therapy",
                        "criterion": "live virus vaccine",
                        "requirement": {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 30,
                                        "unit": "days"
                                    }
                                ]
                            }
                        }
                    },
                    {
                        "exact_snippets": "seasonal influenza vaccines for injection which are generally inactivated flu vaccines are permitted",
                        "criterion": "seasonal influenza vaccines for injection",
                        "requirement": {
                            "requirement_type": "permission",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "intranasal influenza vaccines (e.g., Flu-Mist®) are live attenuated vaccines and are not permitted",
                        "criterion": "intranasal influenza vaccines",
                        "requirement": {
                            "requirement_type": "permission",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "exact_snippets": "failed",
                "criterion": "failed",
                "requirement": {
                    "requirement_type": "failed",
                    "expected_value": "failed"
                }
            }
        }
    ],
    "failed_miscellaneous": []
}