Description:
The purpose of this study is to compare the overall survival of nivolumab versus chemotherapy
in subjects with relapsed SCLC.
Title
- Brief Title: Effectiveness Study of Nivolumab Compared to Chemotherapy in Patients With Relapsed Small-cell Lung Cancer
- 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)
Clinical Trial IDs
- ORG STUDY ID:
CA209-331
- SECONDARY ID:
2015-001097-18
- NCT ID:
NCT02481830
Conditions
Interventions
| Drug | Synonyms | Arms |
|---|
| Nivolumab | | Arm A Nivolumab |
| Topotecan | | Arm B Chemotherapy Topotecan |
| Amrubicin | | Arm B Chemotherapy Amrubicin |
Purpose
The purpose of this study is to compare the overall survival of nivolumab versus chemotherapy
in subjects with relapsed SCLC.
Trial Arms
| Name | Type | Description | Interventions |
|---|
| Arm A Nivolumab | Experimental | Nivolumab intravenous infusion as specified | |
| Arm B Chemotherapy Topotecan | Active Comparator | Topotecan as specified | |
| Arm B Chemotherapy Amrubicin | Active Comparator | Amrubicin intravenous infusion as specified (upon investigator's choice, where locally approved for 2nd line SCLC treatment) | |
Eligibility Criteria
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
| Maximum Eligible Age: | N/A |
| Minimum Eligible Age: | 18 Years |
| Eligible Gender: | All |
| Healthy Volunteers: | No |
Primary Outcome Measures
| Measure: | 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 |
| Safety Issue: | |
| Description: | The time from randomization to the date of death, data was based on Kaplan-Meier Estimates. |
Secondary Outcome Measures
| Measure: | 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. |
| Safety Issue: | |
| Description: | 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. |
| Measure: | 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 |
| Safety Issue: | |
| Description: | 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 |
Details
| Phase: | Phase 3 |
| Primary Purpose: | Interventional |
| Overall Status: | Active, not recruiting |
| Lead Sponsor: | Bristol-Myers Squibb |
Last Updated
August 6, 2020
