Effectiveness Study of Nivolumab Compared to Chemotherapy in Patients With Relapsed Small-cell Lung Cancer (CheckMate331)
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ClinicalTrials.gov Identifier: NCT02481830 |
Recruitment Status :
Active, not recruiting
First Posted : June 25, 2015
Results First Posted : January 9, 2020
Last Update Posted : April 11, 2022
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Lung Cancer | Drug: Nivolumab Drug: Topotecan Drug: Amrubicin | Phase 3 |
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 |

Arm | Intervention/treatment |
---|---|
Experimental: Arm A Nivolumab
Nivolumab intravenous infusion as specified
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Drug: Nivolumab |
Active Comparator: Arm B Chemotherapy Topotecan
Topotecan as specified
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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)
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Drug: Amrubicin |
- 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.
- 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.
- 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

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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

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 ClinicalTrials.gov identifier (NCT number): NCT02481830

Study Director: | Bristol-Myers Squibb | Bristol-Myers Squibb |
Documents provided by Bristol-Myers Squibb:
Responsible Party: | Bristol-Myers Squibb |
ClinicalTrials.gov 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 |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Lung Neoplasms Small Cell Lung Carcinoma Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Neoplasms Lung Diseases Respiratory Tract Diseases Carcinoma, Bronchogenic Bronchial Neoplasms |
Nivolumab Topotecan Amrubicin Antineoplastic Agents, Immunological Antineoplastic Agents Immune Checkpoint Inhibitors Molecular Mechanisms of Pharmacological Action Topoisomerase I Inhibitors Topoisomerase Inhibitors Enzyme Inhibitors |