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.|
|ClinicalTrials.gov Identifier: NCT02481830|
Recruitment Status : Active, not recruiting
First Posted : June 25, 2015
Results First Posted : January 9, 2020
Last Update Posted : August 6, 2020
|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|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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 :||August 28, 2015|
|Actual Primary Completion Date :||August 17, 2018|
|Estimated Study Completion Date :||April 3, 2021|
Experimental: Arm A Nivolumab
Nivolumab intravenous infusion as specified
Active Comparator: Arm B Chemotherapy Topotecan
Topotecan as specified
Active Comparator: Arm B Chemotherapy Amrubicin
Amrubicin intravenous infusion as specified (upon investigator's choice, where locally approved for 2nd line SCLC treatment)
- 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
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|