{
    "info": {
        "nct_id": "NCT02475382",
        "official_title": "Expanded Access Program With Nivolumab Monotherapy in Subjects With Advanced or Metastatic Squamous (Sq) or Non-Squamous (Non-Sq) Non-Small Cell Lung Cancer (NSCLC) Who Have Received at Least One Prior Systemic Regimens for the Treatment of Stage IIIb/IV SqNSCLC",
        "inclusion_criteria": "* Sq or Non-Sq NSCLC, Stage IIIb/IV (histologically or cytologically confirmed)\n* Relapsed after 1 prior platinum-based systemic treatment\n* Eastern Cooperative Oncology Group (ECOG) Performance Status < 2\n* CNS metastasis must be treated and returned to baseline at least 2 weeks before first dose of nivolumab and off steroids or using stable or decreasing dose of < 10 mg prednisone or equivalent\n* Prior chemotherapy, Tyrosine Kinase Inhibitor (TKI) therapy or Immunotherapy (tumor vaccine, cytokine or growth factor to control cancer) must be completed at least 2 weeks before first nivolumab dose\nMust have minimum age of 18 Years",
        "exclusion_criteria": "* CNS metastases (untreated and/or symptomatic)\n* Carcinomatous meningitis\n* ECOG Performance status > 3\n* Corticosteroids > 10 mg prednisolone/day (or equivalent)\n* Prior treatment with anti-PD-1, anti-PD-L-1, anti-PDL2, anti-CT137 or anti-CTLA antibody, including ipilimumab or any other drugs specifically targeting T cell costimulation or checkpoint pathways",
        "miscellaneous_criteria": "For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com"
    },
    "inclusion_lines": [
        {
            "identified_line": {
                "line": "* Relapsed after 1 prior platinum-based systemic treatment",
                "criterions": [
                    {
                        "exact_snippets": "Relapsed after 1 prior platinum-based systemic treatment",
                        "criterion": "relapse",
                        "requirement": {
                            "requirement_type": "treatment history",
                            "expected_value": "1 prior platinum-based systemic treatment"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Relapsed after 1 prior platinum-based systemic treatment",
                        "criterion": "relapse",
                        "requirement": {
                            "requirement_type": "treatment history",
                            "expected_value": "1 prior platinum-based systemic treatment"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Eastern Cooperative Oncology Group (ECOG) Performance Status < 2",
                "criterions": [
                    {
                        "exact_snippets": "Eastern Cooperative Oncology Group (ECOG) Performance Status < 2",
                        "criterion": "ECOG Performance Status",
                        "requirement": {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": "<",
                                "value": 2,
                                "unit": "N/A"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Eastern Cooperative Oncology Group (ECOG) Performance Status < 2",
                        "criterion": "ECOG Performance Status",
                        "requirement": {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": "<",
                                "value": 2,
                                "unit": "N/A"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* CNS metastasis must be treated and returned to baseline at least 2 weeks before first dose of nivolumab and off steroids or using stable or decreasing dose of < 10 mg prednisone or equivalent",
                "criterions": [
                    {
                        "exact_snippets": "CNS metastasis must be treated",
                        "criterion": "CNS metastasis",
                        "requirement": {
                            "requirement_type": "treatment",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "CNS metastasis ... returned to baseline at least 2 weeks before first dose of nivolumab",
                        "criterion": "CNS metastasis",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": "returned to baseline"
                        }
                    },
                    {
                        "exact_snippets": "CNS metastasis ... returned to baseline at least 2 weeks before first dose of nivolumab",
                        "criterion": "CNS metastasis",
                        "requirement": {
                            "requirement_type": "time since baseline",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2,
                                "unit": "weeks"
                            }
                        }
                    },
                    {
                        "exact_snippets": "off steroids or using stable or decreasing dose of < 10 mg prednisone or equivalent",
                        "criterion": "steroid use",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": "off steroids"
                        }
                    },
                    {
                        "exact_snippets": "off steroids or using stable or decreasing dose of < 10 mg prednisone or equivalent",
                        "criterion": "steroid use",
                        "requirement": {
                            "requirement_type": "dose",
                            "expected_value": {
                                "operator": "<",
                                "value": 10,
                                "unit": "mg prednisone or equivalent"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "CNS metastasis must be treated",
                                "criterion": "CNS metastasis",
                                "requirement": {
                                    "requirement_type": "treatment",
                                    "expected_value": true
                                }
                            },
                            {
                                "exact_snippets": "CNS metastasis ... returned to baseline at least 2 weeks before first dose of nivolumab",
                                "criterion": "CNS metastasis",
                                "requirement": {
                                    "requirement_type": "status",
                                    "expected_value": "returned to baseline"
                                }
                            },
                            {
                                "exact_snippets": "CNS metastasis ... returned to baseline at least 2 weeks before first dose of nivolumab",
                                "criterion": "CNS metastasis",
                                "requirement": {
                                    "requirement_type": "time since baseline",
                                    "expected_value": {
                                        "operator": ">=",
                                        "value": 2,
                                        "unit": "weeks"
                                    }
                                }
                            }
                        ]
                    },
                    {
                        "or_criteria": [
                            {
                                "exact_snippets": "off steroids or using stable or decreasing dose of < 10 mg prednisone or equivalent",
                                "criterion": "steroid use",
                                "requirement": {
                                    "requirement_type": "status",
                                    "expected_value": "off steroids"
                                }
                            },
                            {
                                "exact_snippets": "off steroids or using stable or decreasing dose of < 10 mg prednisone or equivalent",
                                "criterion": "steroid use",
                                "requirement": {
                                    "requirement_type": "dose",
                                    "expected_value": {
                                        "operator": "<",
                                        "value": 10,
                                        "unit": "mg prednisone or equivalent"
                                    }
                                }
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Prior chemotherapy, Tyrosine Kinase Inhibitor (TKI) therapy or Immunotherapy (tumor vaccine, cytokine or growth factor to control cancer) must be completed at least 2 weeks before first nivolumab dose",
                "criterions": [
                    {
                        "exact_snippets": "Prior chemotherapy ... must be completed at least 2 weeks before first nivolumab dose",
                        "criterion": "prior chemotherapy",
                        "requirement": {
                            "requirement_type": "completion time",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2,
                                "unit": "weeks"
                            }
                        }
                    },
                    {
                        "exact_snippets": "Tyrosine Kinase Inhibitor (TKI) therapy ... must be completed at least 2 weeks before first nivolumab dose",
                        "criterion": "Tyrosine Kinase Inhibitor (TKI) therapy",
                        "requirement": {
                            "requirement_type": "completion time",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2,
                                "unit": "weeks"
                            }
                        }
                    },
                    {
                        "exact_snippets": "Immunotherapy (tumor vaccine, cytokine or growth factor to control cancer) must be completed at least 2 weeks before first nivolumab dose",
                        "criterion": "immunotherapy",
                        "requirement": {
                            "requirement_type": "completion time",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2,
                                "unit": "weeks"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Prior chemotherapy ... must be completed at least 2 weeks before first nivolumab dose",
                                "criterion": "prior chemotherapy",
                                "requirement": {
                                    "requirement_type": "completion time",
                                    "expected_value": {
                                        "operator": ">=",
                                        "value": 2,
                                        "unit": "weeks"
                                    }
                                }
                            }
                        ]
                    },
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Tyrosine Kinase Inhibitor (TKI) therapy ... must be completed at least 2 weeks before first nivolumab dose",
                                "criterion": "Tyrosine Kinase Inhibitor (TKI) therapy",
                                "requirement": {
                                    "requirement_type": "completion time",
                                    "expected_value": {
                                        "operator": ">=",
                                        "value": 2,
                                        "unit": "weeks"
                                    }
                                }
                            }
                        ]
                    },
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Immunotherapy (tumor vaccine, cytokine or growth factor to control cancer) must be completed at least 2 weeks before first nivolumab dose",
                                "criterion": "immunotherapy",
                                "requirement": {
                                    "requirement_type": "completion time",
                                    "expected_value": {
                                        "operator": ">=",
                                        "value": 2,
                                        "unit": "weeks"
                                    }
                                }
                            }
                        ]
                    }
                ]
            }
        },
        {
            "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": "* CNS metastases (untreated and/or symptomatic)",
                "criterions": [
                    {
                        "exact_snippets": "CNS metastases",
                        "criterion": "CNS metastases",
                        "requirement": {
                            "requirement_type": "treatment status",
                            "expected_value": "untreated"
                        }
                    },
                    {
                        "exact_snippets": "CNS metastases",
                        "criterion": "CNS metastases",
                        "requirement": {
                            "requirement_type": "symptom status",
                            "expected_value": "symptomatic"
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "CNS metastases",
                                "criterion": "CNS metastases",
                                "requirement": {
                                    "requirement_type": "treatment status",
                                    "expected_value": "untreated"
                                }
                            }
                        ]
                    },
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "CNS metastases",
                                "criterion": "CNS metastases",
                                "requirement": {
                                    "requirement_type": "symptom status",
                                    "expected_value": "symptomatic"
                                }
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Carcinomatous meningitis",
                "criterions": [
                    {
                        "exact_snippets": "Carcinomatous meningitis",
                        "criterion": "carcinomatous meningitis",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "not_criteria": {
                    "exact_snippets": "Carcinomatous meningitis",
                    "criterion": "carcinomatous meningitis",
                    "requirement": {
                        "requirement_type": "presence",
                        "expected_value": true
                    }
                }
            }
        },
        {
            "identified_line": {
                "line": "* ECOG Performance status > 3",
                "criterions": [
                    {
                        "exact_snippets": "ECOG Performance status > 3",
                        "criterion": "ECOG Performance status",
                        "requirement": {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": ">",
                                "value": 3,
                                "unit": "N/A"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "not_criteria": {
                    "exact_snippets": "ECOG Performance status > 3",
                    "criterion": "ECOG Performance status",
                    "requirement": {
                        "requirement_type": "severity",
                        "expected_value": {
                            "operator": ">",
                            "value": 3,
                            "unit": "N/A"
                        }
                    }
                }
            }
        },
        {
            "identified_line": {
                "line": "* Corticosteroids > 10 mg prednisolone/day (or equivalent)",
                "criterions": [
                    {
                        "exact_snippets": "Corticosteroids > 10 mg prednisolone/day (or equivalent)",
                        "criterion": "corticosteroids",
                        "requirement": {
                            "requirement_type": "dosage",
                            "expected_value": {
                                "operator": ">",
                                "value": 10,
                                "unit": "mg prednisolone/day (or equivalent)"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Corticosteroids > 10 mg prednisolone/day (or equivalent)",
                        "criterion": "corticosteroids",
                        "requirement": {
                            "requirement_type": "dosage",
                            "expected_value": {
                                "operator": ">",
                                "value": 10,
                                "unit": "mg prednisolone/day (or equivalent)"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Prior treatment with anti-PD-1, anti-PD-L-1, anti-PDL2, anti-CT137 or anti-CTLA antibody, including ipilimumab or any other drugs specifically targeting T cell costimulation or checkpoint pathways",
                "criterions": [
                    {
                        "exact_snippets": "Prior treatment with anti-PD-1",
                        "criterion": "prior treatment with anti-PD-1",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Prior treatment with ... anti-PD-L-1",
                        "criterion": "prior treatment with anti-PD-L-1",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Prior treatment with ... anti-PDL2",
                        "criterion": "prior treatment with anti-PDL2",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Prior treatment with ... anti-CT137",
                        "criterion": "prior treatment with anti-CT137",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Prior treatment with ... anti-CTLA antibody",
                        "criterion": "prior treatment with anti-CTLA antibody",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Prior treatment with ... ipilimumab",
                        "criterion": "prior treatment with ipilimumab",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Prior treatment with ... any other drugs specifically targeting T cell costimulation or checkpoint pathways",
                        "criterion": "prior treatment with drugs targeting T cell costimulation or checkpoint pathways",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Prior treatment with anti-PD-1",
                                "criterion": "prior treatment with anti-PD-1",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": true
                                }
                            },
                            {
                                "exact_snippets": "Prior treatment with ... anti-PD-L-1",
                                "criterion": "prior treatment with anti-PD-L-1",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": true
                                }
                            },
                            {
                                "exact_snippets": "Prior treatment with ... anti-PDL2",
                                "criterion": "prior treatment with anti-PDL2",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": true
                                }
                            },
                            {
                                "exact_snippets": "Prior treatment with ... anti-CT137",
                                "criterion": "prior treatment with anti-CT137",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": true
                                }
                            },
                            {
                                "exact_snippets": "Prior treatment with ... anti-CTLA antibody",
                                "criterion": "prior treatment with anti-CTLA antibody",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": true
                                }
                            },
                            {
                                "exact_snippets": "Prior treatment with ... ipilimumab",
                                "criterion": "prior treatment with ipilimumab",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": true
                                }
                            }
                        ]
                    },
                    {
                        "exact_snippets": "Prior treatment with ... any other drugs specifically targeting T cell costimulation or checkpoint pathways",
                        "criterion": "prior treatment with drugs targeting T cell costimulation or checkpoint pathways",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            }
        }
    ],
    "miscellaneous_lines": [
        {
            "identified_line": {
                "line": "For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com",
                "criterions": []
            },
            "logical_structure": {
                "and_criteria": []
            }
        }
    ],
    "failed_inclusion": [
        {
            "identified_line": {
                "line": "* Sq or Non-Sq NSCLC, Stage IIIb/IV (histologically or cytologically confirmed)",
                "criterions": [
                    {
                        "exact_snippets": "Sq or Non-Sq NSCLC",
                        "criterion": "NSCLC subtype",
                        "requirement": {
                            "requirement_type": "subtype",
                            "expected_value": [
                                "Sq",
                                "Non-Sq"
                            ]
                        }
                    },
                    {
                        "exact_snippets": "Stage IIIb/IV",
                        "criterion": "cancer stage",
                        "requirement": {
                            "requirement_type": "stage",
                            "expected_value": [
                                "IIIb",
                                "IV"
                            ]
                        }
                    },
                    {
                        "exact_snippets": "histologically or cytologically confirmed",
                        "criterion": "confirmation method",
                        "requirement": {
                            "requirement_type": "method",
                            "expected_value": [
                                "histologically",
                                "cytologically"
                            ]
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "or_criteria": [
                            {
                                "exact_snippets": "Sq or Non-Sq NSCLC",
                                "criterion": "NSCLC subtype",
                                "requirement": {
                                    "requirement_type": "subtype",
                                    "expected_value": "Sq"
                                }
                            },
                            {
                                "exact_snippets": "Sq or Non-Sq NSCLC",
                                "criterion": "NSCLC subtype",
                                "requirement": {
                                    "requirement_type": "subtype",
                                    "expected_value": "Non-Sq"
                                }
                            }
                        ]
                    },
                    {
                        "or_criteria": [
                            {
                                "exact_snippets": "Stage IIIb/IV",
                                "criterion": "cancer stage",
                                "requirement": {
                                    "requirement_type": "stage",
                                    "expected_value": "IIIb"
                                }
                            },
                            {
                                "exact_snippets": "Stage IIIb/IV",
                                "criterion": "cancer stage",
                                "requirement": {
                                    "requirement_type": "stage",
                                    "expected_value": "IV"
                                }
                            }
                        ]
                    },
                    {
                        "or_criteria": [
                            {
                                "exact_snippets": "histologically or cytologically confirmed",
                                "criterion": "confirmation method",
                                "requirement": {
                                    "requirement_type": "method",
                                    "expected_value": "histologically"
                                }
                            },
                            {
                                "exact_snippets": "histologically or cytologically confirmed",
                                "criterion": "confirmation method",
                                "requirement": {
                                    "requirement_type": "method",
                                    "expected_value": "cytologically"
                                }
                            }
                        ]
                    }
                ]
            }
        }
    ],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}