{
    "info": {
        "nct_id": "NCT05076760",
        "official_title": "Phase I Study of MEM-288 Oncolytic Virus Alone and in Combination With Nivolumab in Solid Tumors Including Non-Small Cell Lung Cancer (NSCLC)",
        "inclusion_criteria": "1. Ability to understand and provide informed consent.\n2. Willingness and ability to comply with scheduled study visits and procedures.\n3. Adult men or women age ≥ 18 years.\n4. ECOG performance status of 0 or 1.\n5. Part 1 monotherapy: Advanced/metastatic NSCLC, cSCC, Merkel cell, melanoma, TNBC, pancreatic cancer, or head and neck cancer.\n6. Part 2 MEM-288 plus nivolumab combination: Advanced/metastatic NSCLC which has progressed following front-line anti-PD-1/PD-L1 with or without concurrent chemotherapy. No more than one prior line of therapy for advanced/metastatic disease.\n7. Per each tumor type shown below, the specific initial standard of care therapies after which the subjects with specific histologies must have progressed have been included. Subjects will have been treated with at least one or more than one line of therapy prior to enrollment in the study.\n\n   1. Non-small cell lung cancer (NSCLC)\n\n      Part 1 monotherapy\n      * Must have progressed on standard therapy, including platinum-based chemotherapy and checkpoint inhibitor therapy (combined or sequential).\n      * Patients with tumors that have known actionable molecular alteration such in EGFR, ALK, ROS-1, BRAF, RET, MET, and KRAS must have progressed on standard directed molecular therapy, and platinum-based chemotherapy.\n\n      Part 2 MEM-288 plus nivolumab combination\n      * Must have first progression more than (>) 84 days following initiation (cycle 1 day 1) of their most recent anti-PD-1 or PD-L1 checkpoint inhibitor therapy with or without concurrent chemotherapy\n   2. Cutaneous squamous-cell carcinoma (cSCC)\n\n      * Must have progressed on standard therapy, including platinum-based chemotherapy and/or checkpoint inhibitor therapy.\n   3. Merkel cell Carcinoma\n\n      * Must have progressed on standard checkpoint inhibitor therapy.\n   4. Melanoma\n\n      * Subjects must have received a BRAF inhibitor as monotherapy or in combination with other targeted agents for BRAF V600E mutant melanoma.\n      * Subjects must have received an anti-PD-1/ PD-L1inhibitor as monotherapy or combination with anti-CTLA-4 inhibitor or other therapies.\n   5. Pancreatic cancer\n\n      * Progression after systemic chemotherapy which included either gemcitabine or Fluorouracil (5-FU)-based regimen (including capecitabine).\n   6. Triple negative breast cancer (TNBC)\n\n      * Prior treatment (for advanced, metastatic or (neo)adjuvant) must have included a taxane and/or anthracycline-based therapy.\n   7. Head and Neck Cancer\n\n      * Prior treatment requirement in the metastatic or unresectable locally advanced setting include:\n      * Subjects must have received a platinum containing chemotherapy regimen for treatment of primary tumor in locally advanced, or metastatic settings\n      * Subjects must have received an anti-PD-1/ PD-L1 as monotherapy or in combination with chemotherapy.\n8. Progressed following therapy with at least one PD-1 or PD-L1 checkpoint inhibitor (regardless of PD-L1 expression status), except for patients with pancreatic cancer.\n\n   a) Prior progression on a PD-1 or PD-L1 checkpoint inhibitor should be unequivocal; progression that occurs within the first 8 weeks of treatment on these agents should be confirmed with a second CT at least 4 weeks apart (to exclude pseudo-progression).\n9. Patients with activating EGFR mutation or ALK rearrangement which is expected to be responsive to available tyrosine kinase inhibitor therapy, must have been previously treated with an applicable tyrosine kinase inhibitor.\n10. Tumor lesion which is deemed feasible for biopsy and injection under CT or ultrasound guidance (based on size, location, and visibility) by an interventional radiologist, and patient willing and able to provide tissue from biopsy of this lesion. Injected tumor should be > 1 cm3 in volume and should not encase or be inseparable from vital structures such as major nerves or blood vessels.\n\n    a) For Part 1 monotherapy patients treated at the first dose level, the tumor for injection must be an accessible cutaneous, subcutaneous, or superficial lymph node lesion that is palpable.\n11. Measurable disease, as defined per RECIST version 1.1.\n12. Prior history of brain metastases are eligible, provided:\n\n    1. Brain metastases have been treated\n    2. Asymptomatic from the brain metastases\n    3. Corticosteroids prescribed for the management of brain metastases have been discontinued at least 7 days before registration to study\n    4. Brain metastases are stable on pre-registration imaging\n    5. No evidence of leptomeningeal disease\n13. Life expectancy > 3 months.\n14. Adequate organ and marrow function as defined below:\n\n    1. Absolute neutrophil count (ANC) ≥1.5 x 10^9/L\n    2. Hemoglobin ≥90 g/L (or ≥9 g/dL)\n    3. Platelets ≥100 x 10^9/L\n    4. Calculated creatinine clearance of >50 mL/min using Cockcroft Gault equation\n    5. Total bilirubin ≤ 1.5 x institutional upper limit of normal\n    6. AST (SGOT) and ALT (SGPT) ≤2.5 x institutional upper limit of normal\n    7. If Alkaline Phosphatase ≥ 2.5 x institutional upper limit of normal, then AST and ALT must be ≤ 1.5 x institutional upper limit of normal\n15. Patients of childbearing age must not be pregnant and must use established contraceptive strategies:\n\n    1. Female subjects of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.\n    2. Female subjects of childbearing potential should be willing to use 2 methods of birth control or be surgically sterile, or abstain from heterosexual activity for the course of the study through 120 days after the last dose of study medication. Subjects of childbearing potential are those who have not been surgically sterilized or have not been free from menses for > 1 year.\n    3. Male subjects should agree to use an adequate method of barrier contraception starting with the first dose of study therapy through 120 days after the last dose of study therapy.\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "1. Pregnant or breast feeding.\n2. Serious uncontrolled medical disorder, psychiatric condition or laboratory abnormalities that, in the opinion of the investigator, may increase the risk associated with study participation or may interfere with the interpretation of study results.\n3. Major surgery (e.g., intra-thoracic, intra-abdominal or intra-pelvic), or significant traumatic injury, within 4 weeks prior to starting study treatment or has not recovered from side effects of such procedure. Video-assisted thoracic surgery (VATS) and mediastinoscopy are exceptions and patients can receive study treatment ≥1 week after these procedures.\n4. History of clinically significant noninfectious interstitial pneumonitis (i.e., limiting activities of daily living or requiring therapeutic intervention), including clinically significant radiation pneumonitis.\n5. Residual toxicity from prior anticancer therapy of grade 3 or greater (CTCAE v5.0), with the exception of alopecia.\n6. Concurrent use of other anticancer approved or investigational agents.\n7. Clinically significant, uncontrolled heart disease and/or recent cardiac event (within 6 months), such as:\n\n   1. unstable angina within 6 months prior to screening\n   2. myocardial infarction within 6 months prior to screening\n   3. history of documented congestive heart failure (New York Heart Association functional classification III-IV)\n   4. cardiac arrhythmias not controlled with medication\n8. Active autoimmune disease requiring disease modifying therapy (except vitiligo, Grave's, or psoriasis not requiring systemic treatment).\n9. Any form of active primary or secondary immunodeficiency.\n10. Receiving ≥10 mg daily prednisone (or equivalent).\n11. Prior malignancy (except non-melanoma skin cancers, and the following in situ cancers: bladder, gastric, colon, cervical/dysplasia endometrial, melanoma, or breast) are excluded unless a complete remission was achieved at least 2 years prior to study entry AND no additional therapy is required or anticipated to be required during the study period.\n12. Active systemic infections requiring intravenous antibiotics.\n13. Prior therapy with anti-tumor vaccines or other immune-stimulatory antitumor agents (other than FDA approved and National Comprehensive Cancer Network [NCCN] recommended systemic therapies).\n14. Prisoners or subjects who are involuntarily incarcerated, or who are compulsorily detained for treatment of either a psychiatric or physical illness.\n15. Any unresolved grade 2 irAE (except adequately treated endocrine irAE).\n16. Any toxicity that led to permanent discontinuation of prior anti-PD-1/PD-L1 immunotherapy.",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "identified_line": {
                "line": "1. Ability to understand and provide informed consent.",
                "criterions": [
                    {
                        "exact_snippets": "Ability to understand and provide informed consent",
                        "criterion": "informed consent",
                        "requirement": {
                            "requirement_type": "ability to understand",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Ability to understand and provide informed consent",
                        "criterion": "informed consent",
                        "requirement": {
                            "requirement_type": "ability to provide",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Ability to understand and provide informed consent",
                        "criterion": "informed consent",
                        "requirement": {
                            "requirement_type": "ability to understand",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Ability to understand and provide informed consent",
                        "criterion": "informed consent",
                        "requirement": {
                            "requirement_type": "ability to provide",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "2. Willingness and ability to comply with scheduled study visits and procedures.",
                "criterions": [
                    {
                        "exact_snippets": "Willingness ... to comply with scheduled study visits and procedures.",
                        "criterion": "willingness to comply",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "ability to comply with scheduled study visits and procedures.",
                        "criterion": "ability to comply",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Willingness ... to comply with scheduled study visits and procedures.",
                        "criterion": "willingness to comply",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "ability to comply with scheduled study visits and procedures.",
                        "criterion": "ability to comply",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "3. Adult men or women age ≥ 18 years.",
                "criterions": [
                    {
                        "exact_snippets": "Adult men or women",
                        "criterion": "gender",
                        "requirement": {
                            "requirement_type": "N/A",
                            "expected_value": [
                                "male",
                                "female"
                            ]
                        }
                    },
                    {
                        "exact_snippets": "age ≥ 18 years",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "N/A",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Adult men or women",
                        "criterion": "gender",
                        "requirement": {
                            "requirement_type": "N/A",
                            "expected_value": [
                                "male",
                                "female"
                            ]
                        }
                    },
                    {
                        "exact_snippets": "age ≥ 18 years",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "N/A",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "5. Part 1 monotherapy: Advanced/metastatic NSCLC, cSCC, Merkel cell, melanoma, TNBC, pancreatic cancer, or head and neck cancer.",
                "criterions": [
                    {
                        "exact_snippets": "Advanced/metastatic NSCLC",
                        "criterion": "NSCLC",
                        "requirement": {
                            "requirement_type": "stage",
                            "expected_value": [
                                "advanced",
                                "metastatic"
                            ]
                        }
                    },
                    {
                        "exact_snippets": "cSCC",
                        "criterion": "cSCC",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Merkel cell",
                        "criterion": "Merkel cell carcinoma",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "melanoma",
                        "criterion": "melanoma",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "TNBC",
                        "criterion": "TNBC",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "pancreatic cancer",
                        "criterion": "pancreatic cancer",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "head and neck cancer",
                        "criterion": "head and neck cancer",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Advanced/metastatic NSCLC",
                                "criterion": "NSCLC",
                                "requirement": {
                                    "requirement_type": "stage",
                                    "expected_value": [
                                        "advanced",
                                        "metastatic"
                                    ]
                                }
                            }
                        ]
                    },
                    {
                        "exact_snippets": "cSCC",
                        "criterion": "cSCC",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Merkel cell",
                        "criterion": "Merkel cell carcinoma",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "melanoma",
                        "criterion": "melanoma",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "TNBC",
                        "criterion": "TNBC",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "pancreatic cancer",
                        "criterion": "pancreatic cancer",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "head and neck cancer",
                        "criterion": "head and neck cancer",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "6. Part 2 MEM-288 plus nivolumab combination: Advanced/metastatic NSCLC which has progressed following front-line anti-PD-1/PD-L1 with or without concurrent chemotherapy. No more than one prior line of therapy for advanced/metastatic disease.",
                "criterions": [
                    {
                        "exact_snippets": "Advanced/metastatic NSCLC",
                        "criterion": "NSCLC stage",
                        "requirement": {
                            "requirement_type": "stage",
                            "expected_value": "advanced/metastatic"
                        }
                    },
                    {
                        "exact_snippets": "progressed following front-line anti-PD-1/PD-L1",
                        "criterion": "response to front-line anti-PD-1/PD-L1",
                        "requirement": {
                            "requirement_type": "progression",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "with or without concurrent chemotherapy",
                        "criterion": "concurrent chemotherapy",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": "optional"
                        }
                    },
                    {
                        "exact_snippets": "No more than one prior line of therapy for advanced/metastatic disease",
                        "criterion": "prior lines of therapy",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1,
                                "unit": "lines"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Advanced/metastatic NSCLC",
                                "criterion": "NSCLC stage",
                                "requirement": {
                                    "requirement_type": "stage",
                                    "expected_value": "advanced/metastatic"
                                }
                            },
                            {
                                "exact_snippets": "progressed following front-line anti-PD-1/PD-L1",
                                "criterion": "response to front-line anti-PD-1/PD-L1",
                                "requirement": {
                                    "requirement_type": "progression",
                                    "expected_value": true
                                }
                            }
                        ]
                    },
                    {
                        "exact_snippets": "with or without concurrent chemotherapy",
                        "criterion": "concurrent chemotherapy",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": "optional"
                        }
                    },
                    {
                        "exact_snippets": "No more than one prior line of therapy for advanced/metastatic disease",
                        "criterion": "prior lines of therapy",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1,
                                "unit": "lines"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "7. Per each tumor type shown below, the specific initial standard of care therapies after which the subjects with specific histologies must have progressed have been included. Subjects will have been treated with at least one or more than one line of therapy prior to enrollment in the study.",
                "criterions": [
                    {
                        "exact_snippets": "subjects with specific histologies must have progressed",
                        "criterion": "tumor histology progression",
                        "requirement": {
                            "requirement_type": "progression",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Subjects will have been treated with at least one or more than one line of therapy",
                        "criterion": "prior lines of therapy",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1,
                                "unit": "lines of therapy"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "subjects with specific histologies must have progressed",
                        "criterion": "tumor histology progression",
                        "requirement": {
                            "requirement_type": "progression",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Subjects will have been treated with at least one or more than one line of therapy",
                        "criterion": "prior lines of therapy",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1,
                                "unit": "lines of therapy"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "1. Non-small cell lung cancer (NSCLC)",
                "criterions": [
                    {
                        "exact_snippets": "Non-small cell lung cancer (NSCLC)",
                        "criterion": "Non-small cell lung cancer",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Non-small cell lung cancer (NSCLC)",
                        "criterion": "Non-small cell lung cancer",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "Part 1 monotherapy",
                "criterions": [
                    {
                        "exact_snippets": "Part 1 monotherapy",
                        "criterion": "treatment type",
                        "requirement": {
                            "requirement_type": "type",
                            "expected_value": "monotherapy"
                        }
                    },
                    {
                        "exact_snippets": "Part 1 monotherapy",
                        "criterion": "treatment type",
                        "requirement": {
                            "requirement_type": "phase",
                            "expected_value": "Part 1"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Part 1 monotherapy",
                        "criterion": "treatment type",
                        "requirement": {
                            "requirement_type": "type",
                            "expected_value": "monotherapy"
                        }
                    },
                    {
                        "exact_snippets": "Part 1 monotherapy",
                        "criterion": "treatment type",
                        "requirement": {
                            "requirement_type": "phase",
                            "expected_value": "Part 1"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Must have progressed on standard therapy, including platinum-based chemotherapy and checkpoint inhibitor therapy (combined or sequential).",
                "criterions": [
                    {
                        "exact_snippets": "Must have progressed on standard therapy, including platinum-based chemotherapy",
                        "criterion": "progression on platinum-based chemotherapy",
                        "requirement": {
                            "requirement_type": "progression",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Must have progressed on standard therapy, including ... checkpoint inhibitor therapy",
                        "criterion": "progression on checkpoint inhibitor therapy",
                        "requirement": {
                            "requirement_type": "progression",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Must have progressed on standard therapy, including platinum-based chemotherapy",
                                "criterion": "progression on platinum-based chemotherapy",
                                "requirement": {
                                    "requirement_type": "progression",
                                    "expected_value": true
                                }
                            },
                            {
                                "exact_snippets": "Must have progressed on standard therapy, including ... checkpoint inhibitor therapy",
                                "criterion": "progression on checkpoint inhibitor therapy",
                                "requirement": {
                                    "requirement_type": "progression",
                                    "expected_value": true
                                }
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Patients with tumors that have known actionable molecular alteration such in EGFR, ALK, ROS-1, BRAF, RET, MET, and KRAS must have progressed on standard directed molecular therapy, and platinum-based chemotherapy.",
                "criterions": [
                    {
                        "exact_snippets": "tumors that have known actionable molecular alteration such in EGFR, ALK, ROS-1, BRAF, RET, MET, and KRAS",
                        "criterion": "tumor molecular alteration",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": [
                                "EGFR",
                                "ALK",
                                "ROS-1",
                                "BRAF",
                                "RET",
                                "MET",
                                "KRAS"
                            ]
                        }
                    },
                    {
                        "exact_snippets": "must have progressed on standard directed molecular therapy",
                        "criterion": "progression on molecular therapy",
                        "requirement": {
                            "requirement_type": "progression",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "must have progressed on ... platinum-based chemotherapy",
                        "criterion": "progression on platinum-based chemotherapy",
                        "requirement": {
                            "requirement_type": "progression",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "tumors that have known actionable molecular alteration such in EGFR, ALK, ROS-1, BRAF, RET, MET, and KRAS",
                                "criterion": "tumor molecular alteration",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": [
                                        "EGFR",
                                        "ALK",
                                        "ROS-1",
                                        "BRAF",
                                        "RET",
                                        "MET",
                                        "KRAS"
                                    ]
                                }
                            },
                            {
                                "exact_snippets": "must have progressed on standard directed molecular therapy",
                                "criterion": "progression on molecular therapy",
                                "requirement": {
                                    "requirement_type": "progression",
                                    "expected_value": true
                                }
                            }
                        ]
                    },
                    {
                        "exact_snippets": "must have progressed on ... platinum-based chemotherapy",
                        "criterion": "progression on platinum-based chemotherapy",
                        "requirement": {
                            "requirement_type": "progression",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "Part 2 MEM-288 plus nivolumab combination",
                "criterions": [
                    {
                        "exact_snippets": "MEM-288",
                        "criterion": "MEM-288",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "nivolumab",
                        "criterion": "nivolumab",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "MEM-288",
                        "criterion": "MEM-288",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "nivolumab",
                        "criterion": "nivolumab",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Must have first progression more than (>) 84 days following initiation (cycle 1 day 1) of their most recent anti-PD-1 or PD-L1 checkpoint inhibitor therapy with or without concurrent chemotherapy",
                "criterions": [
                    {
                        "exact_snippets": "first progression more than (>) 84 days following initiation (cycle 1 day 1) of their most recent anti-PD-1 or PD-L1 checkpoint inhibitor therapy",
                        "criterion": "time since first progression after anti-PD-1 or PD-L1 therapy",
                        "requirement": {
                            "requirement_type": "time since first progression",
                            "expected_value": {
                                "operator": ">",
                                "value": 84,
                                "unit": "days"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "first progression more than (>) 84 days following initiation (cycle 1 day 1) of their most recent anti-PD-1 or PD-L1 checkpoint inhibitor therapy",
                                "criterion": "time since first progression after anti-PD-1 or PD-L1 therapy",
                                "requirement": {
                                    "requirement_type": "time since first progression",
                                    "expected_value": {
                                        "operator": ">",
                                        "value": 84,
                                        "unit": "days"
                                    }
                                }
                            },
                            {
                                "or_criteria": [
                                    {
                                        "exact_snippets": "...anti-PD-1...",
                                        "criterion": "anti-PD-1 therapy",
                                        "requirement": {
                                            "requirement_type": "presence",
                                            "expected_value": true
                                        }
                                    },
                                    {
                                        "exact_snippets": "...PD-L1...",
                                        "criterion": "PD-L1 therapy",
                                        "requirement": {
                                            "requirement_type": "presence",
                                            "expected_value": true
                                        }
                                    }
                                ]
                            }
                        ]
                    },
                    {
                        "or_criteria": [
                            {
                                "exact_snippets": "...with concurrent chemotherapy",
                                "criterion": "concurrent chemotherapy",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": true
                                }
                            },
                            {
                                "exact_snippets": "...without concurrent chemotherapy",
                                "criterion": "concurrent chemotherapy",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": false
                                }
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "2. Cutaneous squamous-cell carcinoma (cSCC)",
                "criterions": [
                    {
                        "exact_snippets": "Cutaneous squamous-cell carcinoma (cSCC)",
                        "criterion": "cutaneous squamous-cell carcinoma",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Cutaneous squamous-cell carcinoma (cSCC)",
                        "criterion": "cutaneous squamous-cell carcinoma",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Must have progressed on standard therapy, including platinum-based chemotherapy and/or checkpoint inhibitor therapy.",
                "criterions": [
                    {
                        "exact_snippets": "progressed on standard therapy, including platinum-based chemotherapy",
                        "criterion": "progression on platinum-based chemotherapy",
                        "requirement": {
                            "requirement_type": "progression",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "progressed on standard therapy, including ... checkpoint inhibitor therapy",
                        "criterion": "progression on checkpoint inhibitor therapy",
                        "requirement": {
                            "requirement_type": "progression",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "progressed on standard therapy, including platinum-based chemotherapy",
                                "criterion": "progression on platinum-based chemotherapy",
                                "requirement": {
                                    "requirement_type": "progression",
                                    "expected_value": true
                                }
                            }
                        ]
                    },
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "progressed on standard therapy, including ... checkpoint inhibitor therapy",
                                "criterion": "progression on checkpoint inhibitor therapy",
                                "requirement": {
                                    "requirement_type": "progression",
                                    "expected_value": true
                                }
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "3. Merkel cell Carcinoma",
                "criterions": [
                    {
                        "exact_snippets": "Merkel cell Carcinoma",
                        "criterion": "Merkel cell carcinoma",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Merkel cell Carcinoma",
                        "criterion": "Merkel cell carcinoma",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Must have progressed on standard checkpoint inhibitor therapy.",
                "criterions": [
                    {
                        "exact_snippets": "Must have progressed on standard checkpoint inhibitor therapy.",
                        "criterion": "progression on checkpoint inhibitor therapy",
                        "requirement": {
                            "requirement_type": "progression",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Must have progressed on standard checkpoint inhibitor therapy.",
                        "criterion": "progression on checkpoint inhibitor therapy",
                        "requirement": {
                            "requirement_type": "therapy type",
                            "expected_value": "standard checkpoint inhibitor"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Must have progressed on standard checkpoint inhibitor therapy.",
                        "criterion": "progression on checkpoint inhibitor therapy",
                        "requirement": {
                            "requirement_type": "progression",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Must have progressed on standard checkpoint inhibitor therapy.",
                        "criterion": "progression on checkpoint inhibitor therapy",
                        "requirement": {
                            "requirement_type": "therapy type",
                            "expected_value": "standard checkpoint inhibitor"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "4. Melanoma",
                "criterions": [
                    {
                        "exact_snippets": "Melanoma",
                        "criterion": "melanoma",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Melanoma",
                        "criterion": "melanoma",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Subjects must have received a BRAF inhibitor as monotherapy or in combination with other targeted agents for BRAF V600E mutant melanoma.",
                "criterions": [
                    {
                        "exact_snippets": "Subjects must have received a BRAF inhibitor",
                        "criterion": "BRAF inhibitor treatment",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "BRAF V600E mutant melanoma",
                        "criterion": "BRAF V600E mutation",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "or_criteria": [
                            {
                                "and_criteria": [
                                    {
                                        "exact_snippets": "Subjects must have received a BRAF inhibitor",
                                        "criterion": "BRAF inhibitor treatment",
                                        "requirement": {
                                            "requirement_type": "presence",
                                            "expected_value": true
                                        }
                                    },
                                    {
                                        "exact_snippets": "BRAF V600E mutant melanoma",
                                        "criterion": "BRAF V600E mutation",
                                        "requirement": {
                                            "requirement_type": "presence",
                                            "expected_value": true
                                        }
                                    }
                                ]
                            },
                            {
                                "and_criteria": [
                                    {
                                        "exact_snippets": "Subjects must have received a BRAF inhibitor",
                                        "criterion": "BRAF inhibitor treatment",
                                        "requirement": {
                                            "requirement_type": "presence",
                                            "expected_value": true
                                        }
                                    },
                                    {
                                        "exact_snippets": "BRAF V600E mutant melanoma",
                                        "criterion": "BRAF V600E mutation",
                                        "requirement": {
                                            "requirement_type": "presence",
                                            "expected_value": true
                                        }
                                    }
                                ]
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "5. Pancreatic cancer",
                "criterions": [
                    {
                        "exact_snippets": "Pancreatic cancer",
                        "criterion": "pancreatic cancer",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Pancreatic cancer",
                        "criterion": "pancreatic cancer",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Progression after systemic chemotherapy which included either gemcitabine or Fluorouracil (5-FU)-based regimen (including capecitabine).",
                "criterions": [
                    {
                        "exact_snippets": "Progression after systemic chemotherapy",
                        "criterion": "progression after chemotherapy",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "systemic chemotherapy which included either gemcitabine or Fluorouracil (5-FU)-based regimen (including capecitabine)",
                        "criterion": "chemotherapy regimen",
                        "requirement": {
                            "requirement_type": "inclusion",
                            "expected_value": [
                                "gemcitabine",
                                "Fluorouracil (5-FU)",
                                "capecitabine"
                            ]
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Progression after systemic chemotherapy",
                        "criterion": "progression after chemotherapy",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "systemic chemotherapy which included either gemcitabine or Fluorouracil (5-FU)-based regimen (including capecitabine)",
                        "criterion": "chemotherapy regimen",
                        "requirement": {
                            "requirement_type": "inclusion",
                            "expected_value": [
                                "gemcitabine",
                                "Fluorouracil (5-FU)",
                                "capecitabine"
                            ]
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "6. Triple negative breast cancer (TNBC)",
                "criterions": [
                    {
                        "exact_snippets": "Triple negative breast cancer (TNBC)",
                        "criterion": "breast cancer",
                        "requirement": {
                            "requirement_type": "subtype",
                            "expected_value": "triple negative"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Triple negative breast cancer (TNBC)",
                        "criterion": "breast cancer",
                        "requirement": {
                            "requirement_type": "subtype",
                            "expected_value": "triple negative"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "7. Head and Neck Cancer",
                "criterions": [
                    {
                        "exact_snippets": "Head and Neck Cancer",
                        "criterion": "head and neck cancer",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Head and Neck Cancer",
                        "criterion": "head and neck cancer",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Prior treatment requirement in the metastatic or unresectable locally advanced setting include:",
                "criterions": [
                    {
                        "exact_snippets": "Prior treatment requirement in the metastatic or unresectable locally advanced setting",
                        "criterion": "prior treatment",
                        "requirement": {
                            "requirement_type": "setting",
                            "expected_value": [
                                "metastatic",
                                "unresectable locally advanced"
                            ]
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Prior treatment requirement in the metastatic or unresectable locally advanced setting",
                        "criterion": "prior treatment",
                        "requirement": {
                            "requirement_type": "setting",
                            "expected_value": [
                                "metastatic",
                                "unresectable locally advanced"
                            ]
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Subjects must have received a platinum containing chemotherapy regimen for treatment of primary tumor in locally advanced, or metastatic settings",
                "criterions": [
                    {
                        "exact_snippets": "Subjects must have received a platinum containing chemotherapy regimen",
                        "criterion": "platinum containing chemotherapy regimen",
                        "requirement": {
                            "requirement_type": "receipt",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "treatment of primary tumor in locally advanced, or metastatic settings",
                        "criterion": "primary tumor",
                        "requirement": {
                            "requirement_type": "treatment setting",
                            "expected_value": [
                                "locally advanced",
                                "metastatic"
                            ]
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Subjects must have received a platinum containing chemotherapy regimen",
                        "criterion": "platinum containing chemotherapy regimen",
                        "requirement": {
                            "requirement_type": "receipt",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "treatment of primary tumor in locally advanced, or metastatic settings",
                        "criterion": "primary tumor",
                        "requirement": {
                            "requirement_type": "treatment setting",
                            "expected_value": [
                                "locally advanced",
                                "metastatic"
                            ]
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "a) Prior progression on a PD-1 or PD-L1 checkpoint inhibitor should be unequivocal; progression that occurs within the first 8 weeks of treatment on these agents should be confirmed with a second CT at least 4 weeks apart (to exclude pseudo-progression).",
                "criterions": [
                    {
                        "exact_snippets": "Prior progression on a PD-1 or PD-L1 checkpoint inhibitor",
                        "criterion": "progression on PD-1 or PD-L1 checkpoint inhibitor",
                        "requirement": {
                            "requirement_type": "prior occurrence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "progression that occurs within the first 8 weeks of treatment on these agents",
                        "criterion": "progression timing on PD-1 or PD-L1 checkpoint inhibitor",
                        "requirement": {
                            "requirement_type": "timing",
                            "expected_value": {
                                "operator": "<=",
                                "value": 8,
                                "unit": "weeks"
                            }
                        }
                    },
                    {
                        "exact_snippets": "should be confirmed with a second CT at least 4 weeks apart",
                        "criterion": "confirmation of progression",
                        "requirement": {
                            "requirement_type": "confirmation method",
                            "expected_value": "second CT"
                        }
                    },
                    {
                        "exact_snippets": "should be confirmed with a second CT at least 4 weeks apart",
                        "criterion": "confirmation of progression",
                        "requirement": {
                            "requirement_type": "timing",
                            "expected_value": {
                                "operator": ">=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Prior progression on a PD-1 or PD-L1 checkpoint inhibitor",
                                "criterion": "progression on PD-1 or PD-L1 checkpoint inhibitor",
                                "requirement": {
                                    "requirement_type": "prior occurrence",
                                    "expected_value": true
                                }
                            },
                            {
                                "exact_snippets": "progression that occurs within the first 8 weeks of treatment on these agents",
                                "criterion": "progression timing on PD-1 or PD-L1 checkpoint inhibitor",
                                "requirement": {
                                    "requirement_type": "timing",
                                    "expected_value": {
                                        "operator": "<=",
                                        "value": 8,
                                        "unit": "weeks"
                                    }
                                }
                            }
                        ]
                    },
                    {
                        "condition": {
                            "exact_snippets": "progression that occurs within the first 8 weeks of treatment on these agents",
                            "criterion": "progression timing on PD-1 or PD-L1 checkpoint inhibitor",
                            "requirement": {
                                "requirement_type": "timing",
                                "expected_value": {
                                    "operator": "<=",
                                    "value": 8,
                                    "unit": "weeks"
                                }
                            }
                        },
                        "then_criteria": {
                            "and_criteria": [
                                {
                                    "exact_snippets": "should be confirmed with a second CT at least 4 weeks apart",
                                    "criterion": "confirmation of progression",
                                    "requirement": {
                                        "requirement_type": "confirmation method",
                                        "expected_value": "second CT"
                                    }
                                },
                                {
                                    "exact_snippets": "should be confirmed with a second CT at least 4 weeks apart",
                                    "criterion": "confirmation of progression",
                                    "requirement": {
                                        "requirement_type": "timing",
                                        "expected_value": {
                                            "operator": ">=",
                                            "value": 4,
                                            "unit": "weeks"
                                        }
                                    }
                                }
                            ]
                        },
                        "else_criteria": null
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "9. Patients with activating EGFR mutation or ALK rearrangement which is expected to be responsive to available tyrosine kinase inhibitor therapy, must have been previously treated with an applicable tyrosine kinase inhibitor.",
                "criterions": [
                    {
                        "exact_snippets": "activating EGFR mutation",
                        "criterion": "EGFR mutation",
                        "requirement": {
                            "requirement_type": "activation",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "ALK rearrangement",
                        "criterion": "ALK rearrangement",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "responsive to available tyrosine kinase inhibitor therapy",
                        "criterion": "response to tyrosine kinase inhibitor therapy",
                        "requirement": {
                            "requirement_type": "expected response",
                            "expected_value": "responsive"
                        }
                    },
                    {
                        "exact_snippets": "must have been previously treated with an applicable tyrosine kinase inhibitor",
                        "criterion": "previous treatment with tyrosine kinase inhibitor",
                        "requirement": {
                            "requirement_type": "treatment history",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "and_criteria": [
                            {
                                "and_criteria": [
                                    {
                                        "exact_snippets": "activating EGFR mutation",
                                        "criterion": "EGFR mutation",
                                        "requirement": {
                                            "requirement_type": "activation",
                                            "expected_value": true
                                        }
                                    },
                                    {
                                        "exact_snippets": "responsive to available tyrosine kinase inhibitor therapy",
                                        "criterion": "response to tyrosine kinase inhibitor therapy",
                                        "requirement": {
                                            "requirement_type": "expected response",
                                            "expected_value": "responsive"
                                        }
                                    }
                                ]
                            },
                            {
                                "exact_snippets": "must have been previously treated with an applicable tyrosine kinase inhibitor",
                                "criterion": "previous treatment with tyrosine kinase inhibitor",
                                "requirement": {
                                    "requirement_type": "treatment history",
                                    "expected_value": true
                                }
                            }
                        ]
                    },
                    {
                        "and_criteria": [
                            {
                                "and_criteria": [
                                    {
                                        "exact_snippets": "ALK rearrangement",
                                        "criterion": "ALK rearrangement",
                                        "requirement": {
                                            "requirement_type": "presence",
                                            "expected_value": true
                                        }
                                    },
                                    {
                                        "exact_snippets": "responsive to available tyrosine kinase inhibitor therapy",
                                        "criterion": "response to tyrosine kinase inhibitor therapy",
                                        "requirement": {
                                            "requirement_type": "expected response",
                                            "expected_value": "responsive"
                                        }
                                    }
                                ]
                            },
                            {
                                "exact_snippets": "must have been previously treated with an applicable tyrosine kinase inhibitor",
                                "criterion": "previous treatment with tyrosine kinase inhibitor",
                                "requirement": {
                                    "requirement_type": "treatment history",
                                    "expected_value": true
                                }
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "10. Tumor lesion which is deemed feasible for biopsy and injection under CT or ultrasound guidance (based on size, location, and visibility) by an interventional radiologist, and patient willing and able to provide tissue from biopsy of this lesion. Injected tumor should be > 1 cm3 in volume and should not encase or be inseparable from vital structures such as major nerves or blood vessels.",
                "criterions": [
                    {
                        "exact_snippets": "Tumor lesion which is deemed feasible for biopsy and injection under CT or ultrasound guidance (based on size, location, and visibility) by an interventional radiologist",
                        "criterion": "tumor lesion",
                        "requirement": {
                            "requirement_type": "feasibility for biopsy and injection",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "patient willing and able to provide tissue from biopsy of this lesion",
                        "criterion": "patient willingness and ability",
                        "requirement": {
                            "requirement_type": "willingness and ability to provide tissue",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Injected tumor should be > 1 cm3 in volume",
                        "criterion": "injected tumor volume",
                        "requirement": {
                            "requirement_type": "volume",
                            "expected_value": {
                                "operator": ">",
                                "value": 1,
                                "unit": "cm3"
                            }
                        }
                    },
                    {
                        "exact_snippets": "should not encase or be inseparable from vital structures such as major nerves or blood vessels",
                        "criterion": "tumor encasement",
                        "requirement": {
                            "requirement_type": "encasement of vital structures",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Tumor lesion which is deemed feasible for biopsy and injection under CT or ultrasound guidance (based on size, location, and visibility) by an interventional radiologist",
                                "criterion": "tumor lesion",
                                "requirement": {
                                    "requirement_type": "feasibility for biopsy and injection",
                                    "expected_value": true
                                }
                            },
                            {
                                "exact_snippets": "patient willing and able to provide tissue from biopsy of this lesion",
                                "criterion": "patient willingness and ability",
                                "requirement": {
                                    "requirement_type": "willingness and ability to provide tissue",
                                    "expected_value": true
                                }
                            }
                        ]
                    },
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Injected tumor should be > 1 cm3 in volume",
                                "criterion": "injected tumor volume",
                                "requirement": {
                                    "requirement_type": "volume",
                                    "expected_value": {
                                        "operator": ">",
                                        "value": 1,
                                        "unit": "cm3"
                                    }
                                }
                            },
                            {
                                "exact_snippets": "should not encase or be inseparable from vital structures such as major nerves or blood vessels",
                                "criterion": "tumor encasement",
                                "requirement": {
                                    "requirement_type": "encasement of vital structures",
                                    "expected_value": false
                                }
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "a) For Part 1 monotherapy patients treated at the first dose level, the tumor for injection must be an accessible cutaneous, subcutaneous, or superficial lymph node lesion that is palpable.",
                "criterions": [
                    {
                        "exact_snippets": "tumor for injection must be an accessible cutaneous, subcutaneous, or superficial lymph node lesion",
                        "criterion": "tumor for injection",
                        "requirement": {
                            "requirement_type": "location",
                            "expected_value": [
                                "cutaneous",
                                "subcutaneous",
                                "superficial lymph node"
                            ]
                        }
                    },
                    {
                        "exact_snippets": "tumor for injection must be ... palpable",
                        "criterion": "tumor for injection",
                        "requirement": {
                            "requirement_type": "palpability",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "tumor for injection must be an accessible cutaneous, subcutaneous, or superficial lymph node lesion",
                                "criterion": "tumor for injection",
                                "requirement": {
                                    "requirement_type": "location",
                                    "expected_value": [
                                        "cutaneous",
                                        "subcutaneous",
                                        "superficial lymph node"
                                    ]
                                }
                            },
                            {
                                "exact_snippets": "tumor for injection must be ... palpable",
                                "criterion": "tumor for injection",
                                "requirement": {
                                    "requirement_type": "palpability",
                                    "expected_value": true
                                }
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "11. Measurable disease, as defined per RECIST version 1.1.",
                "criterions": [
                    {
                        "exact_snippets": "Measurable disease, as defined per RECIST version 1.1.",
                        "criterion": "measurable disease",
                        "requirement": {
                            "requirement_type": "definition",
                            "expected_value": "RECIST version 1.1"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Measurable disease, as defined per RECIST version 1.1.",
                        "criterion": "measurable disease",
                        "requirement": {
                            "requirement_type": "definition",
                            "expected_value": "RECIST version 1.1"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "12. Prior history of brain metastases are eligible, provided:",
                "criterions": [
                    {
                        "exact_snippets": "Prior history of brain metastases",
                        "criterion": "brain metastases",
                        "requirement": {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "condition": {
                    "exact_snippets": "Prior history of brain metastases",
                    "criterion": "brain metastases",
                    "requirement": {
                        "requirement_type": "history",
                        "expected_value": true
                    }
                },
                "then_criteria": null,
                "else_criteria": null
            }
        },
        {
            "identified_line": {
                "line": "1. Brain metastases have been treated",
                "criterions": [
                    {
                        "exact_snippets": "Brain metastases have been treated",
                        "criterion": "brain metastases",
                        "requirement": {
                            "requirement_type": "treatment status",
                            "expected_value": "treated"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Brain metastases have been treated",
                        "criterion": "brain metastases",
                        "requirement": {
                            "requirement_type": "treatment status",
                            "expected_value": "treated"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "2. Asymptomatic from the brain metastases",
                "criterions": [
                    {
                        "exact_snippets": "Asymptomatic from the brain metastases",
                        "criterion": "brain metastases",
                        "requirement": {
                            "requirement_type": "symptoms",
                            "expected_value": "asymptomatic"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Asymptomatic from the brain metastases",
                        "criterion": "brain metastases",
                        "requirement": {
                            "requirement_type": "symptoms",
                            "expected_value": "asymptomatic"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "3. Corticosteroids prescribed for the management of brain metastases have been discontinued at least 7 days before registration to study",
                "criterions": [
                    {
                        "exact_snippets": "Corticosteroids prescribed for the management of brain metastases have been discontinued at least 7 days before registration to study",
                        "criterion": "corticosteroids for brain metastases",
                        "requirement": {
                            "requirement_type": "discontinuation period",
                            "expected_value": {
                                "operator": ">=",
                                "value": 7,
                                "unit": "days"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Corticosteroids prescribed for the management of brain metastases have been discontinued at least 7 days before registration to study",
                        "criterion": "corticosteroids for brain metastases",
                        "requirement": {
                            "requirement_type": "discontinuation period",
                            "expected_value": {
                                "operator": ">=",
                                "value": 7,
                                "unit": "days"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "4. Brain metastases are stable on pre-registration imaging",
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                    {
                        "exact_snippets": "Brain metastases are stable",
                        "criterion": "brain metastases",
                        "requirement": {
                            "requirement_type": "stability",
                            "expected_value": "stable"
                        }
                    },
                    {
                        "exact_snippets": "pre-registration imaging",
                        "criterion": "pre-registration imaging",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Brain metastases are stable",
                        "criterion": "brain metastases",
                        "requirement": {
                            "requirement_type": "stability",
                            "expected_value": "stable"
                        }
                    },
                    {
                        "exact_snippets": "pre-registration imaging",
                        "criterion": "pre-registration imaging",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "5. No evidence of leptomeningeal disease",
                "criterions": [
                    {
                        "exact_snippets": "No evidence of leptomeningeal disease",
                        "criterion": "leptomeningeal disease",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "No evidence of leptomeningeal disease",
                        "criterion": "leptomeningeal disease",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "13. Life expectancy > 3 months.",
                "criterions": [
                    {
                        "exact_snippets": "Life expectancy > 3 months.",
                        "criterion": "life expectancy",
                        "requirement": {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">",
                                "value": 3,
                                "unit": "months"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Life expectancy > 3 months.",
                        "criterion": "life expectancy",
                        "requirement": {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">",
                                "value": 3,
                                "unit": "months"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "14. Adequate organ and marrow function as defined below:",
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                    {
                        "exact_snippets": "Adequate organ and marrow function",
                        "criterion": "organ and marrow function",
                        "requirement": {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Adequate organ and marrow function",
                        "criterion": "organ and marrow function",
                        "requirement": {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "1. Absolute neutrophil count (ANC) ≥1.5 x 10^9/L",
                "criterions": [
                    {
                        "exact_snippets": "Absolute neutrophil count (ANC) ≥1.5 x 10^9/L",
                        "criterion": "absolute neutrophil count (ANC)",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1.5,
                                "unit": "x 10^9/L"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Absolute neutrophil count (ANC) ≥1.5 x 10^9/L",
                        "criterion": "absolute neutrophil count (ANC)",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1.5,
                                "unit": "x 10^9/L"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "2. Hemoglobin ≥90 g/L (or ≥9 g/dL)",
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                    {
                        "exact_snippets": "Hemoglobin ≥90 g/L (or ≥9 g/dL)",
                        "criterion": "hemoglobin",
                        "requirement": {
                            "requirement_type": "level",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 90,
                                        "unit": "g/L"
                                    },
                                    {
                                        "operator": ">=",
                                        "value": 9,
                                        "unit": "g/dL"
                                    }
                                ]
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Hemoglobin ≥90 g/L (or ≥9 g/dL)",
                        "criterion": "hemoglobin",
                        "requirement": {
                            "requirement_type": "level",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 90,
                                        "unit": "g/L"
                                    },
                                    {
                                        "operator": ">=",
                                        "value": 9,
                                        "unit": "g/dL"
                                    }
                                ]
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "3. Platelets ≥100 x 10^9/L",
                "criterions": [
                    {
                        "exact_snippets": "Platelets ≥100 x 10^9/L",
                        "criterion": "platelet count",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 100,
                                "unit": "x 10^9/L"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Platelets ≥100 x 10^9/L",
                        "criterion": "platelet count",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 100,
                                "unit": "x 10^9/L"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "4. Calculated creatinine clearance of >50 mL/min using Cockcroft Gault equation",
                "criterions": [
                    {
                        "exact_snippets": "Calculated creatinine clearance of >50 mL/min",
                        "criterion": "creatinine clearance",
                        "requirement": {
                            "requirement_type": "calculation method",
                            "expected_value": "Cockcroft Gault equation"
                        }
                    },
                    {
                        "exact_snippets": "Calculated creatinine clearance of >50 mL/min",
                        "criterion": "creatinine clearance",
                        "requirement": {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">",
                                "value": 50,
                                "unit": "mL/min"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Calculated creatinine clearance of >50 mL/min",
                        "criterion": "creatinine clearance",
                        "requirement": {
                            "requirement_type": "calculation method",
                            "expected_value": "Cockcroft Gault equation"
                        }
                    },
                    {
                        "exact_snippets": "Calculated creatinine clearance of >50 mL/min",
                        "criterion": "creatinine clearance",
                        "requirement": {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">",
                                "value": 50,
                                "unit": "mL/min"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "5. Total bilirubin ≤ 1.5 x institutional upper limit of normal",
                "criterions": [
                    {
                        "exact_snippets": "Total bilirubin ≤ 1.5 x institutional upper limit of normal",
                        "criterion": "total bilirubin",
                        "requirement": {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "x institutional upper limit of normal"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Total bilirubin ≤ 1.5 x institutional upper limit of normal",
                        "criterion": "total bilirubin",
                        "requirement": {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "x institutional upper limit of normal"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "6. AST (SGOT) and ALT (SGPT) ≤2.5 x institutional upper limit of normal",
                "criterions": [
                    {
                        "exact_snippets": "AST (SGOT) ... ≤2.5 x institutional upper limit of normal",
                        "criterion": "AST (SGOT)",
                        "requirement": {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2.5,
                                "unit": "x institutional upper limit of normal"
                            }
                        }
                    },
                    {
                        "exact_snippets": "ALT (SGPT) ... ≤2.5 x institutional upper limit of normal",
                        "criterion": "ALT (SGPT)",
                        "requirement": {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2.5,
                                "unit": "x institutional upper limit of normal"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "AST (SGOT) ... ≤2.5 x institutional upper limit of normal",
                        "criterion": "AST (SGOT)",
                        "requirement": {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2.5,
                                "unit": "x institutional upper limit of normal"
                            }
                        }
                    },
                    {
                        "exact_snippets": "ALT (SGPT) ... ≤2.5 x institutional upper limit of normal",
                        "criterion": "ALT (SGPT)",
                        "requirement": {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2.5,
                                "unit": "x institutional upper limit of normal"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "7. If Alkaline Phosphatase ≥ 2.5 x institutional upper limit of normal, then AST and ALT must be ≤ 1.5 x institutional upper limit of normal",
                "criterions": [
                    {
                        "exact_snippets": "Alkaline Phosphatase ≥ 2.5 x institutional upper limit of normal",
                        "criterion": "Alkaline Phosphatase",
                        "requirement": {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2.5,
                                "unit": "x institutional upper limit of normal"
                            }
                        }
                    },
                    {
                        "exact_snippets": "AST and ALT must be ≤ 1.5 x institutional upper limit of normal",
                        "criterion": "AST and ALT",
                        "requirement": {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "x institutional upper limit of normal"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "condition": {
                    "exact_snippets": "Alkaline Phosphatase ≥ 2.5 x institutional upper limit of normal",
                    "criterion": "Alkaline Phosphatase",
                    "requirement": {
                        "requirement_type": "level",
                        "expected_value": {
                            "operator": ">=",
                            "value": 2.5,
                            "unit": "x institutional upper limit of normal"
                        }
                    }
                },
                "then_criteria": {
                    "exact_snippets": "AST and ALT must be ≤ 1.5 x institutional upper limit of normal",
                    "criterion": "AST and ALT",
                    "requirement": {
                        "requirement_type": "level",
                        "expected_value": {
                            "operator": "<=",
                            "value": 1.5,
                            "unit": "x institutional upper limit of normal"
                        }
                    }
                },
                "else_criteria": null
            }
        },
        {
            "identified_line": {
                "line": "15. Patients of childbearing age must not be pregnant and must use established contraceptive strategies:",
                "criterions": [
                    {
                        "exact_snippets": "Patients of childbearing age must not be pregnant",
                        "criterion": "pregnancy",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "Patients of childbearing age ... must use established contraceptive strategies",
                        "criterion": "contraceptive use",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Patients of childbearing age must not be pregnant",
                        "criterion": "pregnancy",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "Patients of childbearing age ... must use established contraceptive strategies",
                        "criterion": "contraceptive use",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "1. Female subjects of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.",
                "criterions": [
                    {
                        "exact_snippets": "Female subjects of childbearing potential",
                        "criterion": "gender and reproductive status",
                        "requirement": {
                            "requirement_type": "expected_value",
                            "expected_value": "female of childbearing potential"
                        }
                    },
                    {
                        "exact_snippets": "negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication",
                        "criterion": "pregnancy test result",
                        "requirement": {
                            "requirement_type": "result",
                            "expected_value": "negative"
                        }
                    },
                    {
                        "exact_snippets": "negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication",
                        "criterion": "pregnancy test result",
                        "requirement": {
                            "requirement_type": "timing",
                            "expected_value": "within 72 hours prior to receiving the first dose of study medication"
                        }
                    }
                ]
            },
            "logical_structure": {
                "condition": {
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                        {
                            "exact_snippets": "Female subjects of childbearing potential",
                            "criterion": "gender and reproductive status",
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                                "requirement_type": "expected_value",
                                "expected_value": "female of childbearing potential"
                            }
                        },
                        {
                            "and_criteria": [
                                {
                                    "exact_snippets": "negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication",
                                    "criterion": "pregnancy test result",
                                    "requirement": {
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                                        "expected_value": "negative"
                                    }
                                },
                                {
                                    "exact_snippets": "negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication",
                                    "criterion": "pregnancy test result",
                                    "requirement": {
                                        "requirement_type": "timing",
                                        "expected_value": "within 72 hours prior to receiving the first dose of study medication"
                                    }
                                }
                            ]
                        }
                    ]
                },
                "then_criteria": null,
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                    "exact_snippets": "negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication",
                    "criterion": "pregnancy test result",
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                        "requirement_type": "result",
                        "expected_value": "negative (serum)"
                    }
                }
            }
        },
        {
            "identified_line": {
                "line": "3. Male subjects should agree to use an adequate method of barrier contraception starting with the first dose of study therapy through 120 days after the last dose of study therapy.",
                "criterions": [
                    {
                        "exact_snippets": "Male subjects",
                        "criterion": "gender",
                        "requirement": {
                            "requirement_type": "expected value",
                            "expected_value": "male"
                        }
                    },
                    {
                        "exact_snippets": "agree to use an adequate method of barrier contraception",
                        "criterion": "contraception method",
                        "requirement": {
                            "requirement_type": "type",
                            "expected_value": "barrier"
                        }
                    },
                    {
                        "exact_snippets": "starting with the first dose of study therapy through 120 days after the last dose of study therapy",
                        "criterion": "contraception duration",
                        "requirement": {
                            "requirement_type": "duration",
                            "expected_value": "from first dose through 120 days after last dose"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Male subjects",
                                "criterion": "gender",
                                "requirement": {
                                    "requirement_type": "expected value",
                                    "expected_value": "male"
                                }
                            },
                            {
                                "exact_snippets": "agree to use an adequate method of barrier contraception",
                                "criterion": "contraception method",
                                "requirement": {
                                    "requirement_type": "type",
                                    "expected_value": "barrier"
                                }
                            }
                        ]
                    },
                    {
                        "exact_snippets": "starting with the first dose of study therapy through 120 days after the last dose of study therapy",
                        "criterion": "contraception duration",
                        "requirement": {
                            "requirement_type": "duration",
                            "expected_value": "from first dose through 120 days after last dose"
                        }
                    }
                ]
            }
        },
        {
            "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": "1. Pregnant or breast feeding.",
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                    {
                        "exact_snippets": "Pregnant",
                        "criterion": "pregnancy",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "breast feeding",
                        "criterion": "breastfeeding",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "exact_snippets": "Pregnant",
                        "criterion": "pregnancy",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "breast feeding",
                        "criterion": "breastfeeding",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "2. Serious uncontrolled medical disorder, psychiatric condition or laboratory abnormalities that, in the opinion of the investigator, may increase the risk associated with study participation or may interfere with the interpretation of study results.",
                "criterions": [
                    {
                        "exact_snippets": "Serious uncontrolled medical disorder",
                        "criterion": "medical disorder",
                        "requirement": {
                            "requirement_type": "control",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "Serious uncontrolled medical disorder",
                        "criterion": "medical disorder",
                        "requirement": {
                            "requirement_type": "severity",
                            "expected_value": "serious"
                        }
                    },
                    {
                        "exact_snippets": "psychiatric condition",
                        "criterion": "psychiatric condition",
                        "requirement": {
                            "requirement_type": "control",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "laboratory abnormalities",
                        "criterion": "laboratory abnormalities",
                        "requirement": {
                            "requirement_type": "control",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "or_criteria": [
                            {
                                "and_criteria": [
                                    {
                                        "and_criteria": [
                                            {
                                                "exact_snippets": "Serious uncontrolled medical disorder",
                                                "criterion": "medical disorder",
                                                "requirement": {
                                                    "requirement_type": "control",
                                                    "expected_value": false
                                                }
                                            },
                                            {
                                                "exact_snippets": "Serious uncontrolled medical disorder",
                                                "criterion": "medical disorder",
                                                "requirement": {
                                                    "requirement_type": "severity",
                                                    "expected_value": "serious"
                                                }
                                            }
                                        ]
                                    },
                                    {
                                        "exact_snippets": "psychiatric condition",
                                        "criterion": "psychiatric condition",
                                        "requirement": {
                                            "requirement_type": "control",
                                            "expected_value": false
                                        }
                                    }
                                ]
                            },
                            {
                                "exact_snippets": "laboratory abnormalities",
                                "criterion": "laboratory abnormalities",
                                "requirement": {
                                    "requirement_type": "control",
                                    "expected_value": false
                                }
                            }
                        ]
                    },
                    {
                        "exact_snippets": "in the opinion of the investigator, may increase the risk associated with study participation or may interfere with the interpretation of study results",
                        "criterion": "investigator opinion on risk or interference",
                        "requirement": {
                            "requirement_type": "N/A",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "3. Major surgery (e.g., intra-thoracic, intra-abdominal or intra-pelvic), or significant traumatic injury, within 4 weeks prior to starting study treatment or has not recovered from side effects of such procedure. Video-assisted thoracic surgery (VATS) and mediastinoscopy are exceptions and patients can receive study treatment ≥1 week after these procedures.",
                "criterions": [
                    {
                        "exact_snippets": "Major surgery (e.g., intra-thoracic, intra-abdominal or intra-pelvic) ... within 4 weeks prior to starting study treatment",
                        "criterion": "major surgery",
                        "requirement": {
                            "requirement_type": "time since procedure",
                            "expected_value": {
                                "operator": "<",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    },
                    {
                        "exact_snippets": "significant traumatic injury, within 4 weeks prior to starting study treatment",
                        "criterion": "significant traumatic injury",
                        "requirement": {
                            "requirement_type": "time since procedure",
                            "expected_value": {
                                "operator": "<",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    },
                    {
                        "exact_snippets": "has not recovered from side effects of such procedure",
                        "criterion": "recovery from side effects",
                        "requirement": {
                            "requirement_type": "recovery status",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "Video-assisted thoracic surgery (VATS) and mediastinoscopy are exceptions ... patients can receive study treatment ≥1 week after these procedures",
                        "criterion": "VATS or mediastinoscopy",
                        "requirement": {
                            "requirement_type": "time since procedure",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1,
                                "unit": "week"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "or_criteria": [
                            {
                                "and_criteria": [
                                    {
                                        "exact_snippets": "Major surgery (e.g., intra-thoracic, intra-abdominal or intra-pelvic) ... within 4 weeks prior to starting study treatment",
                                        "criterion": "major surgery",
                                        "requirement": {
                                            "requirement_type": "time since procedure",
                                            "expected_value": {
                                                "operator": "<",
                                                "value": 4,
                                                "unit": "weeks"
                                            }
                                        }
                                    },
                                    {
                                        "exact_snippets": "has not recovered from side effects of such procedure",
                                        "criterion": "recovery from side effects",
                                        "requirement": {
                                            "requirement_type": "recovery status",
                                            "expected_value": false
                                        }
                                    }
                                ]
                            },
                            {
                                "and_criteria": [
                                    {
                                        "exact_snippets": "significant traumatic injury, within 4 weeks prior to starting study treatment",
                                        "criterion": "significant traumatic injury",
                                        "requirement": {
                                            "requirement_type": "time since procedure",
                                            "expected_value": {
                                                "operator": "<",
                                                "value": 4,
                                                "unit": "weeks"
                                            }
                                        }
                                    },
                                    {
                                        "exact_snippets": "has not recovered from side effects of such procedure",
                                        "criterion": "recovery from side effects",
                                        "requirement": {
                                            "requirement_type": "recovery status",
                                            "expected_value": false
                                        }
                                    }
                                ]
                            }
                        ]
                    },
                    {
                        "not_criteria": {
                            "exact_snippets": "Video-assisted thoracic surgery (VATS) and mediastinoscopy are exceptions ... patients can receive study treatment ≥1 week after these procedures",
                            "criterion": "VATS or mediastinoscopy",
                            "requirement": {
                                "requirement_type": "time since procedure",
                                "expected_value": {
                                    "operator": ">=",
                                    "value": 1,
                                    "unit": "week"
                                }
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                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "4. History of clinically significant noninfectious interstitial pneumonitis (i.e., limiting activities of daily living or requiring therapeutic intervention), including clinically significant radiation pneumonitis.",
                "criterions": [
                    {
                        "exact_snippets": "History of clinically significant noninfectious interstitial pneumonitis",
                        "criterion": "noninfectious interstitial pneumonitis",
                        "requirement": {
                            "requirement_type": "history",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "History of clinically significant noninfectious interstitial pneumonitis",
                        "criterion": "noninfectious interstitial pneumonitis",
                        "requirement": {
                            "requirement_type": "clinical significance",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "clinically significant radiation pneumonitis",
                        "criterion": "radiation pneumonitis",
                        "requirement": {
                            "requirement_type": "clinical significance",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "History of clinically significant noninfectious interstitial pneumonitis",
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                                "requirement": {
                                    "requirement_type": "history",
                                    "expected_value": false
                                }
                            },
                            {
                                "exact_snippets": "History of clinically significant noninfectious interstitial pneumonitis",
                                "criterion": "noninfectious interstitial pneumonitis",
                                "requirement": {
                                    "requirement_type": "clinical significance",
                                    "expected_value": true
                                }
                            }
                        ]
                    },
                    {
                        "exact_snippets": "clinically significant radiation pneumonitis",
                        "criterion": "radiation pneumonitis",
                        "requirement": {
                            "requirement_type": "clinical significance",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "5. Residual toxicity from prior anticancer therapy of grade 3 or greater (CTCAE v5.0), with the exception of alopecia.",
                "criterions": [
                    {
                        "exact_snippets": "Residual toxicity from prior anticancer therapy of grade 3 or greater (CTCAE v5.0)",
                        "criterion": "residual toxicity from prior anticancer therapy",
                        "requirement": {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 3,
                                "unit": "CTCAE v5.0"
                            }
                        }
                    },
                    {
                        "exact_snippets": "with the exception of alopecia",
                        "criterion": "alopecia",
                        "requirement": {
                            "requirement_type": "exception",
                            "expected_value": true
                        }
                    }
                ]
            },
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                    {
                        "not_criteria": {
                            "and_criteria": [
                                {
                                    "exact_snippets": "Residual toxicity from prior anticancer therapy of grade 3 or greater (CTCAE v5.0)",
                                    "criterion": "residual toxicity from prior anticancer therapy",
                                    "requirement": {
                                        "requirement_type": "severity",
                                        "expected_value": {
                                            "operator": ">=",
                                            "value": 3,
                                            "unit": "CTCAE v5.0"
                                        }
                                    }
                                },
                                {
                                    "not_criteria": {
                                        "exact_snippets": "with the exception of alopecia",
                                        "criterion": "alopecia",
                                        "requirement": {
                                            "requirement_type": "exception",
                                            "expected_value": true
                                        }
                                    }
                                }
                            ]
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "6. Concurrent use of other anticancer approved or investigational agents.",
                "criterions": [
                    {
                        "exact_snippets": "Concurrent use of other anticancer approved or investigational agents.",
                        "criterion": "use of anticancer agents",
                        "requirement": {
                            "requirement_type": "concurrency",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Concurrent use of other anticancer approved or investigational agents.",
                        "criterion": "use of anticancer agents",
                        "requirement": {
                            "requirement_type": "concurrency",
                            "expected_value": false
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "7. Clinically significant, uncontrolled heart disease and/or recent cardiac event (within 6 months), such as:",
                "criterions": [
                    {
                        "exact_snippets": "Clinically significant, uncontrolled heart disease",
                        "criterion": "heart disease",
                        "requirement": {
                            "requirement_type": "control",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "Clinically significant, uncontrolled heart disease",
                        "criterion": "heart disease",
                        "requirement": {
                            "requirement_type": "significance",
                            "expected_value": "clinically significant"
                        }
                    },
                    {
                        "exact_snippets": "recent cardiac event (within 6 months)",
                        "criterion": "cardiac event",
                        "requirement": {
                            "requirement_type": "recency",
                            "expected_value": {
                                "operator": "<=",
                                "value": 6,
                                "unit": "months"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Clinically significant, uncontrolled heart disease",
                                "criterion": "heart disease",
                                "requirement": {
                                    "requirement_type": "control",
                                    "expected_value": false
                                }
                            },
                            {
                                "exact_snippets": "Clinically significant, uncontrolled heart disease",
                                "criterion": "heart disease",
                                "requirement": {
                                    "requirement_type": "significance",
                                    "expected_value": "clinically significant"
                                }
                            }
                        ]
                    },
                    {
                        "exact_snippets": "recent cardiac event (within 6 months)",
                        "criterion": "cardiac event",
                        "requirement": {
                            "requirement_type": "recency",
                            "expected_value": {
                                "operator": "<=",
                                "value": 6,
                                "unit": "months"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "1. unstable angina within 6 months prior to screening",
                "criterions": [
                    {
                        "exact_snippets": "unstable angina within 6 months prior to screening",
                        "criterion": "unstable angina",
                        "requirement": {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "operator": "<=",
                                "value": 6,
                                "unit": "months"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "not_criteria": {
                    "exact_snippets": "unstable angina within 6 months prior to screening",
                    "criterion": "unstable angina",
                    "requirement": {
                        "requirement_type": "time frame",
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                            "operator": "<=",
                            "value": 6,
                            "unit": "months"
                        }
                    }
                }
            }
        },
        {
            "identified_line": {
                "line": "2. myocardial infarction within 6 months prior to screening",
                "criterions": [
                    {
                        "exact_snippets": "myocardial infarction within 6 months prior to screening",
                        "criterion": "myocardial infarction",
                        "requirement": {
                            "requirement_type": "time since event",
                            "expected_value": {
                                "operator": "<=",
                                "value": 6,
                                "unit": "months"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "myocardial infarction within 6 months prior to screening",
                        "criterion": "myocardial infarction",
                        "requirement": {
                            "requirement_type": "time since event",
                            "expected_value": {
                                "operator": "<=",
                                "value": 6,
                                "unit": "months"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "3. history of documented congestive heart failure (New York Heart Association functional classification III-IV)",
                "criterions": [
                    {
                        "exact_snippets": "history of documented congestive heart failure",
                        "criterion": "congestive heart failure",
                        "requirement": {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "New York Heart Association functional classification III-IV",
                        "criterion": "New York Heart Association functional classification",
                        "requirement": {
                            "requirement_type": "classification",
                            "expected_value": [
                                "III",
                                "IV"
                            ]
                        }
                    }
                ]
            },
            "logical_structure": {
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                    {
                        "exact_snippets": "history of documented congestive heart failure",
                        "criterion": "congestive heart failure",
                        "requirement": {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "New York Heart Association functional classification III-IV",
                        "criterion": "New York Heart Association functional classification",
                        "requirement": {
                            "requirement_type": "classification",
                            "expected_value": [
                                "III",
                                "IV"
                            ]
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "4. cardiac arrhythmias not controlled with medication",
                "criterions": [
                    {
                        "exact_snippets": "cardiac arrhythmias not controlled with medication",
                        "criterion": "cardiac arrhythmias",
                        "requirement": {
                            "requirement_type": "control with medication",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
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                    {
                        "exact_snippets": "cardiac arrhythmias not controlled with medication",
                        "criterion": "cardiac arrhythmias",
                        "requirement": {
                            "requirement_type": "control with medication",
                            "expected_value": false
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "8. Active autoimmune disease requiring disease modifying therapy (except vitiligo, Grave's, or psoriasis not requiring systemic treatment).",
                "criterions": [
                    {
                        "exact_snippets": "Active autoimmune disease requiring disease modifying therapy",
                        "criterion": "active autoimmune disease",
                        "requirement": {
                            "requirement_type": "treatment requirement",
                            "expected_value": "disease modifying therapy"
                        }
                    },
                    {
                        "exact_snippets": "except vitiligo, Grave's, or psoriasis not requiring systemic treatment",
                        "criterion": "autoimmune disease exceptions",
                        "requirement": {
                            "requirement_type": "exceptions",
                            "expected_value": [
                                "vitiligo",
                                "Grave's",
                                "psoriasis not requiring systemic treatment"
                            ]
                        }
                    }
                ]
            },
            "logical_structure": {
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                    {
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                            "and_criteria": [
                                {
                                    "exact_snippets": "Active autoimmune disease requiring disease modifying therapy",
                                    "criterion": "active autoimmune disease",
                                    "requirement": {
                                        "requirement_type": "treatment requirement",
                                        "expected_value": "disease modifying therapy"
                                    }
                                },
                                {
                                    "not_criteria": {
                                        "exact_snippets": "except vitiligo, Grave's, or psoriasis not requiring systemic treatment",
                                        "criterion": "autoimmune disease exceptions",
                                        "requirement": {
                                            "requirement_type": "exceptions",
                                            "expected_value": [
                                                "vitiligo",
                                                "Grave's",
                                                "psoriasis not requiring systemic treatment"
                                            ]
                                        }
                                    }
                                }
                            ]
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "9. Any form of active primary or secondary immunodeficiency.",
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                    {
                        "exact_snippets": "Any form of active primary or secondary immunodeficiency.",
                        "criterion": "immunodeficiency",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "not_criteria": {
                    "exact_snippets": "Any form of active primary or secondary immunodeficiency.",
                    "criterion": "immunodeficiency",
                    "requirement": {
                        "requirement_type": "presence",
                        "expected_value": false
                    }
                }
            }
        },
        {
            "identified_line": {
                "line": "10. Receiving ≥10 mg daily prednisone (or equivalent).",
                "criterions": [
                    {
                        "exact_snippets": "Receiving ≥10 mg daily prednisone (or equivalent)",
                        "criterion": "prednisone (or equivalent) dosage",
                        "requirement": {
                            "requirement_type": "dosage",
                            "expected_value": {
                                "operator": ">=",
                                "value": 10,
                                "unit": "mg"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "not_criteria": {
                    "exact_snippets": "Receiving ≥10 mg daily prednisone (or equivalent)",
                    "criterion": "prednisone (or equivalent) dosage",
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                        "requirement_type": "dosage",
                        "expected_value": {
                            "operator": ">=",
                            "value": 10,
                            "unit": "mg"
                        }
                    }
                }
            }
        },
        {
            "identified_line": {
                "line": "11. Prior malignancy (except non-melanoma skin cancers, and the following in situ cancers: bladder, gastric, colon, cervical/dysplasia endometrial, melanoma, or breast) are excluded unless a complete remission was achieved at least 2 years prior to study entry AND no additional therapy is required or anticipated to be required during the study period.",
                "criterions": [
                    {
                        "exact_snippets": "Prior malignancy (except non-melanoma skin cancers, and the following in situ cancers: bladder, gastric, colon, cervical/dysplasia endometrial, melanoma, or breast)",
                        "criterion": "prior malignancy",
                        "requirement": {
                            "requirement_type": "exclusion",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "a complete remission was achieved at least 2 years prior to study entry",
                        "criterion": "complete remission",
                        "requirement": {
                            "requirement_type": "time since remission",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2,
                                "unit": "years"
                            }
                        }
                    },
                    {
                        "exact_snippets": "no additional therapy is required or anticipated to be required during the study period",
                        "criterion": "additional therapy",
                        "requirement": {
                            "requirement_type": "requirement",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "condition": {
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                        {
                            "exact_snippets": "Prior malignancy (except non-melanoma skin cancers, and the following in situ cancers: bladder, gastric, colon, cervical/dysplasia endometrial, melanoma, or breast)",
                            "criterion": "prior malignancy",
                            "requirement": {
                                "requirement_type": "exclusion",
                                "expected_value": true
                            }
                        },
                        {
                            "exact_snippets": "a complete remission was achieved at least 2 years prior to study entry",
                            "criterion": "complete remission",
                            "requirement": {
                                "requirement_type": "time since remission",
                                "expected_value": {
                                    "operator": ">=",
                                    "value": 2,
                                    "unit": "years"
                                }
                            }
                        }
                    ]
                },
                "then_criteria": {
                    "exact_snippets": "no additional therapy is required or anticipated to be required during the study period",
                    "criterion": "additional therapy",
                    "requirement": {
                        "requirement_type": "requirement",
                        "expected_value": false
                    }
                },
                "else_criteria": null
            }
        },
        {
            "identified_line": {
                "line": "12. Active systemic infections requiring intravenous antibiotics.",
                "criterions": [
                    {
                        "exact_snippets": "Active systemic infections",
                        "criterion": "systemic infections",
                        "requirement": {
                            "requirement_type": "activity",
                            "expected_value": "active"
                        }
                    },
                    {
                        "exact_snippets": "requiring intravenous antibiotics",
                        "criterion": "intravenous antibiotics",
                        "requirement": {
                            "requirement_type": "necessity",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Active systemic infections",
                        "criterion": "systemic infections",
                        "requirement": {
                            "requirement_type": "activity",
                            "expected_value": "active"
                        }
                    },
                    {
                        "exact_snippets": "requiring intravenous antibiotics",
                        "criterion": "intravenous antibiotics",
                        "requirement": {
                            "requirement_type": "necessity",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "14. Prisoners or subjects who are involuntarily incarcerated, or who are compulsorily detained for treatment of either a psychiatric or physical illness.",
                "criterions": [
                    {
                        "exact_snippets": "Prisoners",
                        "criterion": "prisoner status",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "subjects who are involuntarily incarcerated",
                        "criterion": "involuntary incarceration",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "subjects who are ... compulsorily detained for treatment of either a psychiatric or physical illness",
                        "criterion": "compulsory detention for treatment",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "exact_snippets": "Prisoners",
                        "criterion": "prisoner status",
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                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "subjects who are involuntarily incarcerated",
                        "criterion": "involuntary incarceration",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "subjects who are ... compulsorily detained for treatment of either a psychiatric or physical illness",
                        "criterion": "compulsory detention for treatment",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "15. Any unresolved grade 2 irAE (except adequately treated endocrine irAE).",
                "criterions": [
                    {
                        "exact_snippets": "unresolved grade 2 irAE",
                        "criterion": "irAE",
                        "requirement": {
                            "requirement_type": "resolution",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "unresolved grade 2 irAE",
                        "criterion": "irAE",
                        "requirement": {
                            "requirement_type": "grade",
                            "expected_value": {
                                "operator": "=",
                                "value": 2,
                                "unit": "grade"
                            }
                        }
                    },
                    {
                        "exact_snippets": "adequately treated endocrine irAE",
                        "criterion": "endocrine irAE",
                        "requirement": {
                            "requirement_type": "treatment status",
                            "expected_value": "adequately treated"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "unresolved grade 2 irAE",
                                "criterion": "irAE",
                                "requirement": {
                                    "requirement_type": "resolution",
                                    "expected_value": false
                                }
                            },
                            {
                                "exact_snippets": "unresolved grade 2 irAE",
                                "criterion": "irAE",
                                "requirement": {
                                    "requirement_type": "grade",
                                    "expected_value": {
                                        "operator": "=",
                                        "value": 2,
                                        "unit": "grade"
                                    }
                                }
                            }
                        ]
                    },
                    {
                        "not_criteria": {
                            "exact_snippets": "adequately treated endocrine irAE",
                            "criterion": "endocrine irAE",
                            "requirement": {
                                "requirement_type": "treatment status",
                                "expected_value": "adequately treated"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "16. Any toxicity that led to permanent discontinuation of prior anti-PD-1/PD-L1 immunotherapy.",
                "criterions": [
                    {
                        "exact_snippets": "toxicity that led to permanent discontinuation of prior anti-PD-1/PD-L1 immunotherapy",
                        "criterion": "toxicity from prior anti-PD-1/PD-L1 immunotherapy",
                        "requirement": {
                            "requirement_type": "severity",
                            "expected_value": "led to permanent discontinuation"
                        }
                    }
                ]
            },
            "logical_structure": {
                "not_criteria": {
                    "exact_snippets": "toxicity that led to permanent discontinuation of prior anti-PD-1/PD-L1 immunotherapy",
                    "criterion": "toxicity from prior anti-PD-1/PD-L1 immunotherapy",
                    "requirement": {
                        "requirement_type": "severity",
                        "expected_value": "led to permanent discontinuation"
                    }
                }
            }
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [
        {
            "identified_line": {
                "line": "4. ECOG performance status of 0 or 1.",
                "criterions": [
                    {
                        "exact_snippets": "ECOG performance status of 0 or 1",
                        "criterion": "ECOG performance status",
                        "requirement": {
                            "requirement_type": "value",
                            "expected_value": [
                                "0",
                                "1"
                            ]
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "exact_snippets": "ECOG performance status of 0 or 1",
                        "criterion": "ECOG performance status",
                        "requirement": {
                            "requirement_type": "value",
                            "expected_value": "0"
                        }
                    },
                    {
                        "exact_snippets": "ECOG performance status of 0 or 1",
                        "criterion": "ECOG performance status",
                        "requirement": {
                            "requirement_type": "value",
                            "expected_value": "1"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Prior treatment (for advanced, metastatic or (neo)adjuvant) must have included a taxane and/or anthracycline-based therapy.",
                "criterions": [
                    {
                        "exact_snippets": "Prior treatment ... must have included a taxane and/or anthracycline-based therapy.",
                        "criterion": "prior treatment",
                        "requirement": {
                            "requirement_type": "inclusion",
                            "expected_value": [
                                "taxane-based therapy",
                                "anthracycline-based therapy"
                            ]
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Prior treatment ... must have included a taxane and/or anthracycline-based therapy.",
                                "criterion": "prior treatment",
                                "requirement": {
                                    "requirement_type": "inclusion",
                                    "expected_value": "taxane-based therapy"
                                }
                            }
                        ]
                    },
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Prior treatment ... must have included a taxane and/or anthracycline-based therapy.",
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                                    "requirement_type": "inclusion",
                                    "expected_value": "anthracycline-based therapy"
                                }
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Subjects must have received an anti-PD-1/ PD-L1 as monotherapy or in combination with chemotherapy.",
                "criterions": [
                    {
                        "exact_snippets": "Subjects must have received an anti-PD-1/ PD-L1",
                        "criterion": "anti-PD-1/PD-L1 therapy",
                        "requirement": {
                            "requirement_type": "treatment history",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "as monotherapy or in combination with chemotherapy",
                        "criterion": "therapy type",
                        "requirement": {
                            "requirement_type": "type",
                            "expected_value": [
                                "monotherapy",
                                "combination with chemotherapy"
                            ]
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Subjects must have received an anti-PD-1/ PD-L1",
                                "criterion": "anti-PD-1/PD-L1 therapy",
                                "requirement": {
                                    "requirement_type": "treatment history",
                                    "expected_value": true
                                }
                            },
                            {
                                "or_criteria": [
                                    {
                                        "exact_snippets": "as monotherapy or in combination with chemotherapy",
                                        "criterion": "therapy type",
                                        "requirement": {
                                            "requirement_type": "type",
                                            "expected_value": "monotherapy"
                                        }
                                    },
                                    {
                                        "exact_snippets": "as monotherapy or in combination with chemotherapy",
                                        "criterion": "therapy type",
                                        "requirement": {
                                            "requirement_type": "type",
                                            "expected_value": "combination with chemotherapy"
                                        }
                                    }
                                ]
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "8. Progressed following therapy with at least one PD-1 or PD-L1 checkpoint inhibitor (regardless of PD-L1 expression status), except for patients with pancreatic cancer.",
                "criterions": [
                    {
                        "exact_snippets": "Progressed following therapy with at least one PD-1 or PD-L1 checkpoint inhibitor",
                        "criterion": "progression after PD-1 or PD-L1 therapy",
                        "requirement": {
                            "requirement_type": "progression",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "except for patients with pancreatic cancer",
                        "criterion": "pancreatic cancer",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Progressed following therapy with at least one PD-1 or PD-L1 checkpoint inhibitor",
                                "criterion": "progression after PD-1 or PD-L1 therapy",
                                "requirement": {
                                    "requirement_type": "progression",
                                    "expected_value": true
                                }
                            },
                            {
                                "not_criteria": {
                                    "exact_snippets": "except for patients with pancreatic cancer",
                                    "criterion": "pancreatic cancer",
                                    "requirement": {
                                        "requirement_type": "presence",
                                        "expected_value": true
                                    }
                                }
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "2. Female subjects of childbearing potential should be willing to use 2 methods of birth control or be surgically sterile, or abstain from heterosexual activity for the course of the study through 120 days after the last dose of study medication. Subjects of childbearing potential are those who have not been surgically sterilized or have not been free from menses for > 1 year.",
                "criterions": [
                    {
                        "exact_snippets": "Female subjects of childbearing potential",
                        "criterion": "gender and reproductive status",
                        "requirement": {
                            "requirement_type": "gender",
                            "expected_value": "female"
                        }
                    },
                    {
                        "exact_snippets": "Female subjects of childbearing potential",
                        "criterion": "gender and reproductive status",
                        "requirement": {
                            "requirement_type": "reproductive status",
                            "expected_value": "childbearing potential"
                        }
                    },
                    {
                        "exact_snippets": "willing to use 2 methods of birth control",
                        "criterion": "birth control methods",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2,
                                "unit": "methods"
                            }
                        }
                    },
                    {
                        "exact_snippets": "be surgically sterile",
                        "criterion": "surgical sterility",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "abstain from heterosexual activity",
                        "criterion": "sexual activity",
                        "requirement": {
                            "requirement_type": "abstinence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "for the course of the study through 120 days after the last dose of study medication",
                        "criterion": "duration of birth control or abstinence",
                        "requirement": {
                            "requirement_type": "duration",
                            "expected_value": "course of the study through 120 days after the last dose of study medication"
                        }
                    },
                    {
                        "exact_snippets": "Subjects of childbearing potential are those who have not been surgically sterilized",
                        "criterion": "surgical sterilization",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "have not been free from menses for > 1 year",
                        "criterion": "menstrual status",
                        "requirement": {
                            "requirement_type": "duration without menses",
                            "expected_value": {
                                "operator": ">",
                                "value": 1,
                                "unit": "year"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "exact_snippets": "failed",
                "criterion": "failed",
                "requirement": {
                    "requirement_type": "failed",
                    "expected_value": "failed"
                }
            }
        },
        {
            "identified_line": {
                "line": "* Subjects must have received an anti-PD-1/ PD-L1inhibitor as monotherapy or combination with anti-CTLA-4 inhibitor or other therapies.",
                "criterions": [
                    {
                        "exact_snippets": "Subjects must have received an anti-PD-1/ PD-L1 inhibitor",
                        "criterion": "anti-PD-1/PD-L1 inhibitor treatment",
                        "requirement": {
                            "requirement_type": "treatment history",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "monotherapy or combination with anti-CTLA-4 inhibitor or other therapies",
                        "criterion": "treatment combination",
                        "requirement": {
                            "requirement_type": "treatment type",
                            "expected_value": [
                                "monotherapy",
                                "combination with anti-CTLA-4 inhibitor",
                                "combination with other therapies"
                            ]
                        }
                    }
                ]
            },
            "logical_structure": {
                "exact_snippets": "failed",
                "criterion": "failed",
                "requirement": {
                    "requirement_type": "failed",
                    "expected_value": "failed"
                }
            }
        }
    ],
    "failed_exclusion": [
        {
            "identified_line": {
                "line": "13. Prior therapy with anti-tumor vaccines or other immune-stimulatory antitumor agents (other than FDA approved and National Comprehensive Cancer Network [NCCN] recommended systemic therapies).",
                "criterions": [
                    {
                        "exact_snippets": "Prior therapy with anti-tumor vaccines or other immune-stimulatory antitumor agents",
                        "criterion": "prior therapy with anti-tumor vaccines or other immune-stimulatory antitumor agents",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "other than FDA approved and National Comprehensive Cancer Network [NCCN] recommended systemic therapies",
                        "criterion": "FDA approved and NCCN recommended systemic therapies",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "condition": {
                    "exact_snippets": "Prior therapy with anti-tumor vaccines or other immune-stimulatory antitumor agents",
                    "criterion": "prior therapy with anti-tumor vaccines or other immune-stimulatory antitumor agents",
                    "requirement": {
                        "requirement_type": "presence",
                        "expected_value": true
                    }
                },
                "then_criteria": {
                    "not_criteria": {
                        "exact_snippets": "other than FDA approved and National Comprehensive Cancer Network [NCCN] recommended systemic therapies",
                        "criterion": "FDA approved and NCCN recommended systemic therapies",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                },
                "else_criteria": null
            }
        }
    ],
    "failed_miscellaneous": []
}