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

Gender: --
Maximum age: 99
Minimum age: 18
Inclusion criteria:
1)Subjects with SCLC documented by histology or cytology.
2)Initial diagnosis with extensive stage disease (Stage IV).
3) ECOG Performance Status 0 or 1.
4)Subjects must have received 4 cycles of platinum-based first line chemotherapy and must have an ongoing response of complete response (CR), partial response (PR), or stable disease (SD) after completion of chemotherapy.
5) Randomized ≤ 7 weeks from the last dose of platinum-based first line chemotherapy.
6) A formalin-fixed, paraffin-embedded (FFPE) tumor tissue block or 10 unstained slides of tumor sample (archival or recent) must be available for biomarker evaluation.

Exclusion criteria:
1.Subjects with untreated central nervous system metastases are excluded
2.Subjects with active, known, or suspected autoimmune disease are excluded
3.All side effects attributed to prior anti-cancer therapy must have resolved to Grade 1 or baseline