Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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
Sponsor:
Collaborator:
Ono Pharmaceutical Co. Ltd
Information provided by (Responsible Party):
Bristol-Myers Squibb

Tracking Information
First Submitted Date  ICMJE June 23, 2015
First Posted Date  ICMJE June 25, 2015
Results First Submitted Date  ICMJE August 13, 2019
Results First Posted Date  ICMJE January 9, 2020
Last Update Posted Date August 6, 2020
Actual Study Start Date  ICMJE August 28, 2015
Actual Primary Completion Date August 17, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 6, 2020)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: June 23, 2015)
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 ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 6, 2020)
  • 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
Original Secondary Outcome Measures  ICMJE
 (submitted: June 23, 2015)
  • Progression Free Survival (PFS ) [ Time Frame: upto 12 months ]
  • Objective Response Rate (ORR) [ Time Frame: upto 12 months ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effectiveness Study of Nivolumab Compared to Chemotherapy in Patients With Relapsed Small-cell Lung Cancer
Official Title  ICMJE 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)
Brief Summary The purpose of this study is to compare the overall survival of nivolumab versus chemotherapy in subjects with relapsed SCLC.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Lung Cancer
Intervention  ICMJE
  • Drug: Nivolumab
  • Drug: Topotecan
  • Drug: Amrubicin
Study Arms  ICMJE
  • Experimental: Arm A Nivolumab
    Nivolumab intravenous infusion as specified
    Intervention: Drug: Nivolumab
  • Active Comparator: Arm B Chemotherapy Topotecan
    Topotecan as specified
    Intervention: 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)
    Intervention: Drug: Amrubicin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: September 25, 2018)
803
Original Estimated Enrollment  ICMJE
 (submitted: June 23, 2015)
480
Estimated Study Completion Date  ICMJE April 3, 2021
Actual Primary Completion Date August 17, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   Austria,   Belgium,   Brazil,   Chile,   China,   Czechia,   Denmark,   France,   Germany,   Greece,   Hungary,   Israel,   Italy,   Japan,   Korea, Republic of,   Norway,   Poland,   Romania,   Russian Federation,   Spain,   Switzerland,   Taiwan,   United Kingdom,   United States
Removed Location Countries Czech Republic,   Netherlands
 
Administrative Information
NCT Number  ICMJE NCT02481830
Other Study ID Numbers  ICMJE CA209-331
2015-001097-18 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Bristol-Myers Squibb
Study Sponsor  ICMJE Bristol-Myers Squibb
Collaborators  ICMJE Ono Pharmaceutical Co. Ltd
Investigators  ICMJE
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
PRS Account Bristol-Myers Squibb
Verification Date August 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP