{
    "info": {
        "nct_id": "NCT02538666",
        "official_title": "A Randomized, Multicenter, Double-Blind, Phase 3 Study of Nivolumab, Nivolumab in Combination With Ipilimumab, or Placebo as Maintenance Therapy in Subjects With Extensive-Stage Disease Small Cell Lung Cancer (ED-SCLC) After Completion of Platinum-based First Line Chemotherapy (CheckMate 451: CHECKpoint Pathway and nivoluMAb Clinical Trial Evaluation 451)",
        "inclusion_criteria": "* Subjects with histologically or cytologically confirmed extensive stage disease SCLC\n* Ongoing response of stable disease or better following 4 cycles of platinum-based first line chemotherapy\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "* Subjects with symptomatic Central Nervous System (CNS) metastases\n* Subjects receiving consolidative chest radiation\n* Subjects with active, known, or suspected autoimmune disease are excluded\n* All side effects attributed to prior anti-cancer therapy must have resolved to Grade 1 or baseline\n\nOther protocol-defined inclusion/exclusion criteria apply",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Subjects with histologically or cytologically confirmed extensive stage disease SCLC",
            "criterions": [
                {
                    "exact_snippets": "histologically or cytologically confirmed extensive stage disease SCLC",
                    "criterion": "extensive stage disease SCLC",
                    "requirements": [
                        {
                            "requirement_type": "confirmation method",
                            "expected_value": [
                                "histologically",
                                "cytologically"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Ongoing response of stable disease or better following 4 cycles of platinum-based first line chemotherapy",
            "criterions": [
                {
                    "exact_snippets": "Ongoing response of stable disease or better",
                    "criterion": "disease response",
                    "requirements": [
                        {
                            "requirement_type": "response level",
                            "expected_value": [
                                "stable disease",
                                "better"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "following 4 cycles of platinum-based first line chemotherapy",
                    "criterion": "platinum-based first line chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "completion",
                            "expected_value": "4 cycles"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1",
            "criterions": [
                {
                    "exact_snippets": "Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1",
                    "criterion": "ECOG performance status",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": [
                                "0",
                                "1"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "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": "* Subjects with symptomatic Central Nervous System (CNS) metastases",
            "criterions": [
                {
                    "exact_snippets": "symptomatic Central Nervous System (CNS) metastases",
                    "criterion": "Central Nervous System (CNS) metastases",
                    "requirements": [
                        {
                            "requirement_type": "symptomatic",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Subjects receiving consolidative chest radiation",
            "criterions": [
                {
                    "exact_snippets": "Subjects receiving consolidative chest radiation",
                    "criterion": "consolidative chest radiation",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Subjects with active, known, or suspected autoimmune disease are excluded",
            "criterions": [
                {
                    "exact_snippets": "active, known, or suspected autoimmune disease",
                    "criterion": "autoimmune disease",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": [
                                "active",
                                "known",
                                "suspected"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* All side effects attributed to prior anti-cancer therapy must have resolved to Grade 1 or baseline",
            "criterions": [
                {
                    "exact_snippets": "All side effects attributed to prior anti-cancer therapy must have resolved to Grade 1 or baseline",
                    "criterion": "side effects from prior anti-cancer therapy",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "Grade 1 or baseline"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Other protocol-defined inclusion/exclusion criteria apply",
            "criterions": [
                {
                    "exact_snippets": "Other protocol-defined inclusion/exclusion criteria apply",
                    "criterion": "protocol-defined inclusion/exclusion criteria",
                    "requirements": [
                        {
                            "requirement_type": "application",
                            "expected_value": true
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}