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

Not Applicable

• Conditions: -C349 Bronchus or lung, unspecified; Bronchus or lung, unspecified; C349

• Registration Number: PER-060-15
• Lead Sponsor: BRISTOL MYERS SQUIBB COMPANY,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-04-05
• Study Completion: 2020-12-09
• Last Update Posted: 4 September 2023

Recruitment & Eligibility

• Status: Complete
• Sex: Not specified
• Target Recruitment: 2

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified