{
    "info": {
        "nct_id": "NCT03663166",
        "official_title": "Radiation and Chemotherapy With Ipilimumab Followed by Nivolumab for Patients With Stage III Unresectable NSCLC",
        "inclusion_criteria": "* Over 18 years of age\n* Participants must have signed and dated a written informed consent form.\n* Participants must be willing and able to comply with proposed visit and treatment schedule.\n* Patients with NSCLC documented by histology or cytology from brushing, washing, or needle aspiration of a defined lesion, but not from sputum cytology alone.\n* Patients must have presented at initial diagnosis with Stage III disease according to American Joint Committee on Cancer (AJCC) Staging Manual, 8th Edition;\n* Patients must be deemed by the treating investigator to be surgically unresectable. I\n* Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0 or 1\n* Patients must initiate study treatment 60 days from the date of pathologic diagnosis.\n* Tumor biopsy specimen including at least formalin-fixed, paraffin-embedded (FFPE) tumor tissue block or 10 unstained slides of tumor sample (archival or recent) for biomarker evaluation must be available for submission to the central lab for correlative studies.\n* Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test within 14 days prior to the start of thoracic radiation therapy.\n* Male participants must be willing to refrain from sperm donation during the entire study and for 5 half-lives of study drug plus 90 days (duration of sperm turnover).\n* Investigators shall counsel WOCBP and male participants who are sexually active with WOCBP on the importance of pregnancy prevention and the implications of an unexpected pregnancy. Investigators shall advise on the use of highly effective methods of contraception which have a failure rate of </= 1% when used consistently and correctly. Azoospermic males are exempt from contraceptive requirements.\n* WOCBP must agree to follow instructions for method(s) of contraception for the duration of treatment with study drug(s) plus 5 half-lives of study drug (half-life up to 25 days) plus 30 days (duration of ovulatory cycle) for a total of 5 months post-treatment completion.\n* WOCBP who are continuously not heterosexually active are exempt from contraception requirements. However, they must still undergo pregnancy testing as described in this section.\n* Males who are sexually active with WOCBP must agree to follow instructions for method(s) of contraception for the duration of treatment with study drug (s) plus 5 half-lives of the study drug (half-life up to 25 days) plus 90 days (duration of sperm turnover) for a total of 7 months post-treatment completion\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "* All toxicities attributed to prior anti-cancer therapy must have been resolved to Grade 1 (NCI CTCAE Version 4) or baseline before administration of study drug(s). Exceptions may apply.\n* Women who are pregnant or breastfeeding\n* Active, known, or suspected autoimmune disease. Patients with an autoimmune paraneoplastic syndrome requiring concurrent immunosuppressive treatment are excluded. Patients with type I diabetes mellitus, hypothyroidism only requiring hormone replacement, skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll\n* A condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of study initiation. Corticosteroids with minimal systemic absorption (inhaled or topical steroids) and adrenal replacement steroid doses > 10 mg daily prednisone equivalent are permitted in the absence of active autoimmune disease\n* Prior therapy with anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-CTLA-4 antibody\n* Interstitial lung disease that is symptomatic or may interfere with the detection or management of suspected drug-related pulmonary toxicity.\n* Any patient requiring supplemental oxygen therapy.\n* Previous malignancies (except non-melanoma skin cancers, and some in situ cancers) unless a complete remission was achieved at least 2 years prior to study entry AND no additional therapy is required during the study period.\n* Known medical condition that, in the investigator's opinion, would increase the risk associated with study participation or study drug(s) administration or interfere with the interpretation of safety results\n* Major surgery or significant traumatic injury that is not recovered at least 14 days before the initiation of thoracic radiation therapy.\n* Positive test for hepatitis B virus (HBV) using HBV surface antigen (HBVsAg) test or positive test for hepatitis C virus (HCV) using HCV ribonucleic acid (RNA) or HCV antibody test indicating acute or chronic infection. Individuals with a positive test for HCV antibody but no detection of HCV RNA indicating no current infection are eligible.\n* Known medical history of testing positive for human immunodeficiency virus (HIV) or known medical history of acquired immunodeficiency syndrome (AIDS)\n* Inadequate hematologic function.\n* Inadequate hepatic function.\n* Inadequate pancreatic function.\n* History of allergy or hypersensitivity to any of the study drugs or study drug components",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Over 18 years of age",
            "criterions": [
                {
                    "exact_snippets": "Over 18 years of age",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Participants must have signed and dated a written informed consent form.",
            "criterions": [
                {
                    "exact_snippets": "signed and dated a written informed consent form",
                    "criterion": "informed consent",
                    "requirements": [
                        {
                            "requirement_type": "completion",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Participants must be willing and able to comply with proposed visit and treatment schedule.",
            "criterions": [
                {
                    "exact_snippets": "Participants must be willing and able to comply with proposed visit and treatment schedule.",
                    "criterion": "compliance with visit and treatment schedule",
                    "requirements": [
                        {
                            "requirement_type": "willingness",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients with NSCLC documented by histology or cytology from brushing, washing, or needle aspiration of a defined lesion, but not from sputum cytology alone.",
            "criterions": [
                {
                    "exact_snippets": "Patients with NSCLC documented by histology or cytology",
                    "criterion": "NSCLC documentation",
                    "requirements": [
                        {
                            "requirement_type": "method",
                            "expected_value": [
                                "histology",
                                "cytology"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "from brushing, washing, or needle aspiration of a defined lesion",
                    "criterion": "method of obtaining sample",
                    "requirements": [
                        {
                            "requirement_type": "method",
                            "expected_value": [
                                "brushing",
                                "washing",
                                "needle aspiration"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "not from sputum cytology alone",
                    "criterion": "sputum cytology",
                    "requirements": [
                        {
                            "requirement_type": "exclusion",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients must have presented at initial diagnosis with Stage III disease according to American Joint Committee on Cancer (AJCC) Staging Manual, 8th Edition;",
            "criterions": [
                {
                    "exact_snippets": "Stage III disease according to American Joint Committee on Cancer (AJCC) Staging Manual, 8th Edition",
                    "criterion": "cancer stage",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": "Stage III"
                        },
                        {
                            "requirement_type": "staging system",
                            "expected_value": "American Joint Committee on Cancer (AJCC) Staging Manual, 8th Edition"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients must be deemed by the treating investigator to be surgically unresectable. I",
            "criterions": [
                {
                    "exact_snippets": "Patients must be deemed by the treating investigator to be surgically unresectable.",
                    "criterion": "surgical resectability",
                    "requirements": [
                        {
                            "requirement_type": "assessment",
                            "expected_value": "unresectable"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0 or 1",
            "criterions": [
                {
                    "exact_snippets": "Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0 or 1",
                    "criterion": "ECOG Performance Status",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": [
                                "0",
                                "1"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients must initiate study treatment 60 days from the date of pathologic diagnosis.",
            "criterions": [
                {
                    "exact_snippets": "initiate study treatment 60 days from the date of pathologic diagnosis",
                    "criterion": "study treatment initiation",
                    "requirements": [
                        {
                            "requirement_type": "timing",
                            "expected_value": {
                                "operator": "<=",
                                "value": 60,
                                "unit": "days"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Tumor biopsy specimen including at least formalin-fixed, paraffin-embedded (FFPE) tumor tissue block or 10 unstained slides of tumor sample (archival or recent) for biomarker evaluation must be available for submission to the central lab for correlative studies.",
            "criterions": [
                {
                    "exact_snippets": "Tumor biopsy specimen including at least formalin-fixed, paraffin-embedded (FFPE) tumor tissue block or 10 unstained slides of tumor sample (archival or recent) for biomarker evaluation must be available",
                    "criterion": "tumor biopsy specimen",
                    "requirements": [
                        {
                            "requirement_type": "availability",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "formalin-fixed, paraffin-embedded (FFPE) tumor tissue block or 10 unstained slides of tumor sample",
                    "criterion": "tumor tissue format",
                    "requirements": [
                        {
                            "requirement_type": "format",
                            "expected_value": [
                                "formalin-fixed, paraffin-embedded (FFPE) tumor tissue block",
                                "10 unstained slides"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "archival or recent",
                    "criterion": "tumor sample recency",
                    "requirements": [
                        {
                            "requirement_type": "recency",
                            "expected_value": [
                                "archival",
                                "recent"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test within 14 days prior to the start of thoracic radiation therapy.",
            "criterions": [
                {
                    "exact_snippets": "Women of childbearing potential (WOCBP)",
                    "criterion": "gender and reproductive status",
                    "requirements": [
                        {
                            "requirement_type": "expected gender",
                            "expected_value": "female"
                        },
                        {
                            "requirement_type": "reproductive status",
                            "expected_value": "childbearing potential"
                        }
                    ]
                },
                {
                    "exact_snippets": "must have a negative serum or urine pregnancy test",
                    "criterion": "pregnancy test result",
                    "requirements": [
                        {
                            "requirement_type": "result",
                            "expected_value": "negative"
                        }
                    ]
                },
                {
                    "exact_snippets": "within 14 days prior to the start of thoracic radiation therapy",
                    "criterion": "timing of pregnancy test",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "operator": "<=",
                                "value": 14,
                                "unit": "days"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Male participants must be willing to refrain from sperm donation during the entire study and for 5 half-lives of study drug plus 90 days (duration of sperm turnover).",
            "criterions": [
                {
                    "exact_snippets": "Male participants",
                    "criterion": "gender",
                    "requirements": [
                        {
                            "requirement_type": "expected gender",
                            "expected_value": "male"
                        }
                    ]
                },
                {
                    "exact_snippets": "willing to refrain from sperm donation",
                    "criterion": "sperm donation",
                    "requirements": [
                        {
                            "requirement_type": "willingness to refrain",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "during the entire study and for 5 half-lives of study drug plus 90 days",
                    "criterion": "duration of sperm donation restriction",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": "entire study and for 5 half-lives of study drug plus 90 days"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Investigators shall counsel WOCBP and male participants who are sexually active with WOCBP on the importance of pregnancy prevention and the implications of an unexpected pregnancy. Investigators shall advise on the use of highly effective methods of contraception which have a failure rate of </= 1% when used consistently and correctly. Azoospermic males are exempt from contraceptive requirements.",
            "criterions": [
                {
                    "exact_snippets": "WOCBP",
                    "criterion": "women of childbearing potential (WOCBP)",
                    "requirements": [
                        {
                            "requirement_type": "counseling",
                            "expected_value": "importance of pregnancy prevention and implications of an unexpected pregnancy"
                        }
                    ]
                },
                {
                    "exact_snippets": "male participants who are sexually active with WOCBP",
                    "criterion": "male participants sexually active with WOCBP",
                    "requirements": [
                        {
                            "requirement_type": "counseling",
                            "expected_value": "importance of pregnancy prevention and implications of an unexpected pregnancy"
                        }
                    ]
                },
                {
                    "exact_snippets": "use of highly effective methods of contraception which have a failure rate of </= 1%",
                    "criterion": "contraception methods",
                    "requirements": [
                        {
                            "requirement_type": "failure rate",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1,
                                "unit": "%"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Azoospermic males are exempt from contraceptive requirements",
                    "criterion": "azoospermic males",
                    "requirements": [
                        {
                            "requirement_type": "contraceptive requirements",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* WOCBP must agree to follow instructions for method(s) of contraception for the duration of treatment with study drug(s) plus 5 half-lives of study drug (half-life up to 25 days) plus 30 days (duration of ovulatory cycle) for a total of 5 months post-treatment completion.",
            "criterions": [
                {
                    "exact_snippets": "WOCBP must agree to follow instructions for method(s) of contraception",
                    "criterion": "contraception",
                    "requirements": [
                        {
                            "requirement_type": "agreement",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "duration of treatment with study drug(s) plus 5 half-lives of study drug (half-life up to 25 days) plus 30 days (duration of ovulatory cycle) for a total of 5 months post-treatment completion",
                    "criterion": "contraception duration",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": "duration of treatment with study drug(s) plus 5 half-lives of study drug (half-life up to 25 days) plus 30 days (duration of ovulatory cycle) for a total of 5 months post-treatment completion"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* WOCBP who are continuously not heterosexually active are exempt from contraception requirements. However, they must still undergo pregnancy testing as described in this section.",
            "criterions": [
                {
                    "exact_snippets": "WOCBP who are continuously not heterosexually active",
                    "criterion": "WOCBP heterosexual activity",
                    "requirements": [
                        {
                            "requirement_type": "activity status",
                            "expected_value": "not heterosexually active"
                        }
                    ]
                },
                {
                    "exact_snippets": "they must still undergo pregnancy testing",
                    "criterion": "pregnancy testing",
                    "requirements": [
                        {
                            "requirement_type": "requirement",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Males who are sexually active with WOCBP must agree to follow instructions for method(s) of contraception for the duration of treatment with study drug (s) plus 5 half-lives of the study drug (half-life up to 25 days) plus 90 days (duration of sperm turnover) for a total of 7 months post-treatment completion",
            "criterions": [
                {
                    "exact_snippets": "Males who are sexually active with WOCBP",
                    "criterion": "gender and sexual activity",
                    "requirements": [
                        {
                            "requirement_type": "gender",
                            "expected_value": "male"
                        },
                        {
                            "requirement_type": "sexual activity",
                            "expected_value": "active with WOCBP"
                        }
                    ]
                },
                {
                    "exact_snippets": "must agree to follow instructions for method(s) of contraception",
                    "criterion": "contraception agreement",
                    "requirements": [
                        {
                            "requirement_type": "agreement",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "for the duration of treatment with study drug (s) plus 5 half-lives of the study drug (half-life up to 25 days) plus 90 days (duration of sperm turnover) for a total of 7 months post-treatment completion",
                    "criterion": "contraception duration",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": "7 months post-treatment completion"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Healthy volunteers allowed",
            "criterions": [
                {
                    "exact_snippets": "Healthy volunteers allowed",
                    "criterion": "volunteer health status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "healthy"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must have minimum age of 18 Years",
            "criterions": [
                {
                    "exact_snippets": "minimum age of 18 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "* All toxicities attributed to prior anti-cancer therapy must have been resolved to Grade 1 (NCI CTCAE Version 4) or baseline before administration of study drug(s). Exceptions may apply.",
            "criterions": [
                {
                    "exact_snippets": "All toxicities attributed to prior anti-cancer therapy must have been resolved to Grade 1 (NCI CTCAE Version 4) or baseline",
                    "criterion": "toxicities from prior anti-cancer therapy",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "Grade 1 or baseline"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Women who are pregnant or breastfeeding",
            "criterions": [
                {
                    "exact_snippets": "Women who are pregnant",
                    "criterion": "pregnancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "breastfeeding",
                    "criterion": "breastfeeding",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Active, known, or suspected autoimmune disease. Patients with an autoimmune paraneoplastic syndrome requiring concurrent immunosuppressive treatment are excluded. Patients with type I diabetes mellitus, hypothyroidism only requiring hormone replacement, skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll",
            "criterions": [
                {
                    "exact_snippets": "Active, known, or suspected autoimmune disease.",
                    "criterion": "autoimmune disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "autoimmune paraneoplastic syndrome requiring concurrent immunosuppressive treatment are excluded.",
                    "criterion": "autoimmune paraneoplastic syndrome",
                    "requirements": [
                        {
                            "requirement_type": "treatment",
                            "expected_value": "concurrent immunosuppressive treatment"
                        }
                    ]
                },
                {
                    "exact_snippets": "type I diabetes mellitus",
                    "criterion": "type I diabetes mellitus",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "hypothyroidism only requiring hormone replacement",
                    "criterion": "hypothyroidism",
                    "requirements": [
                        {
                            "requirement_type": "treatment",
                            "expected_value": "hormone replacement"
                        }
                    ]
                },
                {
                    "exact_snippets": "skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment",
                    "criterion": "skin disorders",
                    "requirements": [
                        {
                            "requirement_type": "treatment",
                            "expected_value": "not requiring systemic treatment"
                        }
                    ]
                },
                {
                    "exact_snippets": "conditions not expected to recur in the absence of an external trigger",
                    "criterion": "conditions not expected to recur",
                    "requirements": [
                        {
                            "requirement_type": "recurrence",
                            "expected_value": "absence of an external trigger"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* A condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of study initiation. Corticosteroids with minimal systemic absorption (inhaled or topical steroids) and adrenal replacement steroid doses > 10 mg daily prednisone equivalent are permitted in the absence of active autoimmune disease",
            "criterions": [
                {
                    "exact_snippets": "systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of study initiation",
                    "criterion": "systemic treatment",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Corticosteroids with minimal systemic absorption (inhaled or topical steroids)",
                    "criterion": "corticosteroids with minimal systemic absorption",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "adrenal replacement steroid doses > 10 mg daily prednisone equivalent",
                    "criterion": "adrenal replacement steroid doses",
                    "requirements": [
                        {
                            "requirement_type": "dosage",
                            "expected_value": {
                                "operator": ">",
                                "value": 10,
                                "unit": "mg daily prednisone equivalent"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "active autoimmune disease",
                    "criterion": "active autoimmune disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Prior therapy with anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-CTLA-4 antibody",
            "criterions": [
                {
                    "exact_snippets": "Prior therapy with anti-PD-1",
                    "criterion": "prior therapy with anti-PD-1 antibody",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Prior therapy with ... anti-PD-L1",
                    "criterion": "prior therapy with anti-PD-L1 antibody",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Prior therapy with ... anti-PD-L2",
                    "criterion": "prior therapy with anti-PD-L2 antibody",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Prior therapy with ... anti-CD137",
                    "criterion": "prior therapy with anti-CD137 antibody",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Prior therapy with ... anti-CTLA-4 antibody",
                    "criterion": "prior therapy with anti-CTLA-4 antibody",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Interstitial lung disease that is symptomatic or may interfere with the detection or management of suspected drug-related pulmonary toxicity.",
            "criterions": [
                {
                    "exact_snippets": "Interstitial lung disease that is symptomatic",
                    "criterion": "interstitial lung disease",
                    "requirements": [
                        {
                            "requirement_type": "symptomatic",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Interstitial lung disease ... may interfere with the detection or management of suspected drug-related pulmonary toxicity",
                    "criterion": "interstitial lung disease",
                    "requirements": [
                        {
                            "requirement_type": "interference with detection or management of pulmonary toxicity",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Any patient requiring supplemental oxygen therapy.",
            "criterions": [
                {
                    "exact_snippets": "Any patient requiring supplemental oxygen therapy.",
                    "criterion": "supplemental oxygen therapy",
                    "requirements": [
                        {
                            "requirement_type": "requirement",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Previous malignancies (except non-melanoma skin cancers, and some in situ cancers) unless a complete remission was achieved at least 2 years prior to study entry AND no additional therapy is required during the study period.",
            "criterions": [
                {
                    "exact_snippets": "Previous malignancies (except non-melanoma skin cancers, and some in situ cancers)",
                    "criterion": "previous malignancies",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "unless a complete remission was achieved at least 2 years prior to study entry",
                    "criterion": "complete remission",
                    "requirements": [
                        {
                            "requirement_type": "time since remission",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2,
                                "unit": "years"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "no additional therapy is required during the study period",
                    "criterion": "additional therapy",
                    "requirements": [
                        {
                            "requirement_type": "requirement",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Known medical condition that, in the investigator's opinion, would increase the risk associated with study participation or study drug(s) administration or interfere with the interpretation of safety results",
            "criterions": [
                {
                    "exact_snippets": "Known medical condition that, in the investigator's opinion, would increase the risk associated with study participation",
                    "criterion": "medical condition",
                    "requirements": [
                        {
                            "requirement_type": "risk",
                            "expected_value": "increase"
                        }
                    ]
                },
                {
                    "exact_snippets": "Known medical condition that, in the investigator's opinion, would ... interfere with the interpretation of safety results",
                    "criterion": "medical condition",
                    "requirements": [
                        {
                            "requirement_type": "interference",
                            "expected_value": "interpretation of safety results"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Major surgery or significant traumatic injury that is not recovered at least 14 days before the initiation of thoracic radiation therapy.",
            "criterions": [
                {
                    "exact_snippets": "Major surgery or significant traumatic injury that is not recovered at least 14 days before the initiation of thoracic radiation therapy.",
                    "criterion": "recovery from major surgery or significant traumatic injury",
                    "requirements": [
                        {
                            "requirement_type": "time since recovery",
                            "expected_value": {
                                "operator": ">=",
                                "value": 14,
                                "unit": "days"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Positive test for hepatitis B virus (HBV) using HBV surface antigen (HBVsAg) test or positive test for hepatitis C virus (HCV) using HCV ribonucleic acid (RNA) or HCV antibody test indicating acute or chronic infection. Individuals with a positive test for HCV antibody but no detection of HCV RNA indicating no current infection are eligible.",
            "criterions": [
                {
                    "exact_snippets": "Positive test for hepatitis B virus (HBV) using HBV surface antigen (HBVsAg) test",
                    "criterion": "hepatitis B virus (HBV) infection",
                    "requirements": [
                        {
                            "requirement_type": "test result",
                            "expected_value": "positive"
                        }
                    ]
                },
                {
                    "exact_snippets": "positive test for hepatitis C virus (HCV) using HCV ribonucleic acid (RNA) or HCV antibody test indicating acute or chronic infection",
                    "criterion": "hepatitis C virus (HCV) infection",
                    "requirements": [
                        {
                            "requirement_type": "test result",
                            "expected_value": "positive"
                        }
                    ]
                },
                {
                    "exact_snippets": "Individuals with a positive test for HCV antibody but no detection of HCV RNA indicating no current infection are eligible",
                    "criterion": "current hepatitis C virus (HCV) infection",
                    "requirements": [
                        {
                            "requirement_type": "test result",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Known medical history of testing positive for human immunodeficiency virus (HIV) or known medical history of acquired immunodeficiency syndrome (AIDS)",
            "criterions": [
                {
                    "exact_snippets": "Known medical history of testing positive for human immunodeficiency virus (HIV)",
                    "criterion": "HIV status",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "known medical history of acquired immunodeficiency syndrome (AIDS)",
                    "criterion": "AIDS status",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Inadequate hematologic function.",
            "criterions": [
                {
                    "exact_snippets": "Inadequate hematologic function.",
                    "criterion": "hematologic function",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Inadequate hepatic function.",
            "criterions": [
                {
                    "exact_snippets": "Inadequate hepatic function.",
                    "criterion": "hepatic function",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Inadequate pancreatic function.",
            "criterions": [
                {
                    "exact_snippets": "Inadequate pancreatic function",
                    "criterion": "pancreatic function",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* History of allergy or hypersensitivity to any of the study drugs or study drug components",
            "criterions": [
                {
                    "exact_snippets": "History of allergy or hypersensitivity to any of the study drugs or study drug components",
                    "criterion": "allergy or hypersensitivity",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}