This trial is active, not recruiting.

Condition lung cancer
Treatments nivolumab, topotecan, amrubicin
Phase phase 3
Target PD-1
Sponsor Bristol-Myers Squibb
Collaborator Ono Pharmaceutical Co. Ltd
Start date August 2015
End date March 2018
Trial size 558 participants
Trial identifier NCT02481830, 2015-001097-18, CA209-331


The purpose of this study is to compare the overall survival of nivolumab versus chemotherapy in subjects with relapsed SCLC.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Nivolumab intravenous infusion as specified
(Active Comparator)
Topotecan as specified
(Active Comparator)
Amrubicin intravenous infusion as specified (upon investigator's choice, where locally approved for 2nd line SCLC treatment)

Primary Outcomes

Overall survival (OS) in subjects with relapsed SCLC
time frame: approximately 12 months. Additional survival follow-up may continue for up to 5 years from the completion of the study

Secondary Outcomes

Progression free survival (PFS)
time frame: upto 12 months
Objective response rate (ORR)
time frame: upto 12 months

Eligibility Criteria

Male or female participants at least 18 years old.

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com 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

Additional Information

Official title 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)
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by Bristol-Myers Squibb.