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Effectiveness Study of Nivolumab Compared to Chemotherapy in Patients With Relapsed Small-cell Lung Cancer (CheckMate331)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02481830
Recruitment Status : Active, not recruiting
First Posted : June 25, 2015
Results First Posted : January 9, 2020
Last Update Posted : April 11, 2022
Ono Pharmaceutical Co. Ltd
Information provided by (Responsible Party):
Bristol-Myers Squibb

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

Condition or disease Intervention/treatment Phase
Lung Cancer Drug: Nivolumab Drug: Topotecan Drug: Amrubicin Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 803 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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)
Actual Study Start Date : September 14, 2015
Actual Primary Completion Date : August 17, 2018
Estimated Study Completion Date : May 30, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Arm Intervention/treatment
Experimental: Arm A Nivolumab
Nivolumab intravenous infusion as specified
Drug: Nivolumab
Active Comparator: Arm B Chemotherapy Topotecan
Topotecan as specified
Drug: Topotecan
Active Comparator: Arm B Chemotherapy Amrubicin
Amrubicin intravenous infusion as specified (upon investigator's choice, where locally approved for 2nd line SCLC treatment)
Drug: Amrubicin

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. Progression Free Survival (PFS ) [ Time Frame: assessed every 6 weeks from the first dose to week 30, and every 12 weeks up to 34 months. ]

    the time from randomization to the date of the first documented tumor progression (based on investigator assesment,using Response Evaluation Criteria in Solid Tumors (RECIST)1.1 criteria) or death the data was based on Kaplan-Meier Estimates.

    PFS was censored when subsequent anti cancer therapy was started before progression.

  2. Objective Response Rate (ORR) [ Time Frame: Between the date of randomization and the date of progression or the date of subsequent anti-cancer therapy,whichever occurs first up to 34 months ]
    The proportion of all randomized Participants who achieved BOR(Best Overall response) from baseline is either a CR(complete response) or PR(Partial response),using the RECIST v1.1 criteria based on investigator assessment,CR+PR, confidence interval based on the Clopper and Pearson method

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02481830

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Sponsors and Collaborators
Bristol-Myers Squibb
Ono Pharmaceutical Co. Ltd
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Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  Study Documents (Full-Text)

Documents provided by Bristol-Myers Squibb:
Study Protocol  [PDF] April 22, 2015
Statistical Analysis Plan  [PDF] August 14, 2018

Additional Information:
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Responsible Party: Bristol-Myers Squibb Identifier: NCT02481830    
Other Study ID Numbers: CA209-331
2015-001097-18 ( EudraCT Number )
First Posted: June 25, 2015    Key Record Dates
Results First Posted: January 9, 2020
Last Update Posted: April 11, 2022
Last Verified: April 2022

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Lung Neoplasms
Small Cell Lung Carcinoma
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Antineoplastic Agents, Immunological
Antineoplastic Agents
Immune Checkpoint Inhibitors
Molecular Mechanisms of Pharmacological Action
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors