NCT02481830
Completed
Phase 3
An Open-label, Randomized, Phase 3 Study of Nivolumab or Chemotherapy in Subjects With Relapsed Small-cell Lung Cancer After Platinum-based First Line Chemotherapy (CheckMate 331: CHECKpoint Pathway and nivoluMAb Clinical Trial Evaluation 331)
Overview
- Phase
- Phase 3
- Intervention
- Nivolumab
- Conditions
- Lung Cancer
- Sponsor
- Bristol-Myers Squibb
- Enrollment
- 569
- Locations
- 151
- Primary Endpoint
- Overall Survival (OS)
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
The purpose of this study is to compare the overall survival of nivolumab versus chemotherapy in subjects with relapsed SCLC.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Histologically or cytologically confirmed small cell lung cancer (SCLC)
- •Subjects with either limited or extensive disease stage at the initial diagnosis
- •Must have recurrence or progression after platinum-based first-line chemotherapy or chemoradiation therapy for the treatment of limited or extensive disease stage SCLC
- •Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
Exclusion Criteria
- •Untreated or symptomatic central nervous system (CNS) metastases
- •Prior therapy with anti-PD-1, anti-PDL1, anti-PD-L2, anti-CD137, or anti-CTLA-4 antibody
- •Inadequate hematologic or hepatic function
Arms & Interventions
Arm A Nivolumab
Nivolumab intravenous infusion as specified
Intervention: Nivolumab
Arm B Chemotherapy Topotecan
Topotecan as specified
Intervention: Topotecan
Arm B Chemotherapy Amrubicin
Amrubicin intravenous infusion as specified (upon investigator's choice, where locally approved for 2nd line SCLC treatment)
Intervention: Amrubicin
Outcomes
Primary Outcomes
Overall Survival (OS)
Time Frame: OS was followed continuously while participants were on the study drug and every 3 months, minimum follow up for overall survival was 15.8 months
The time from randomization to the date of death, data was based on Kaplan-Meier Estimates. A participant who has not died will be censored at last known date alive.
Secondary Outcomes
- Progression Free Survival (PFS)(From randomization to the date of first documented tumor progression, or death due to any cause. Tumor response assessed every 6 weeks from first dose until week 30, and every 12 weeks (Up to approximately 80 months))
- Objective Response Rate (ORR)(From randomization to the date of objectively documented progression or the date of subsequent anti-cancer therapy, whichever occurs first (Up to approximately 80 months))
Study Sites (151)
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