Clinical Trials /

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

NCT02481830

Description:

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

Related Conditions:
  • Small Cell Lung Carcinoma
Recruiting Status:

Active, not recruiting

Phase:

Phase 3

Trial Eligibility

Document

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

Trial Conditions

  • Lung Cancer

Trial Interventions

DrugSynonymsArms
NivolumabArm A Nivolumab
TopotecanArm B Chemotherapy Topotecan
AmrubicinArm B Chemotherapy Amrubicin

Trial Purpose

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

Detailed Description

Trial Arms

NameTypeDescriptionInterventions
Arm A NivolumabExperimentalNivolumab intravenous infusion as specified
  • Nivolumab
    Arm B Chemotherapy TopotecanActive ComparatorTopotecan as specified
      • Topotecan
      Arm B Chemotherapy AmrubicinActive ComparatorAmrubicin intravenous infusion as specified (upon investigator's choice, where locally approved for 2nd line SCLC treatment)
          • Amrubicin

      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:Both
      Healthy Volunteers:No

      Primary Outcome Measures

      Measure: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
      Safety Issue:No
      Description:

      Secondary Outcome Measures

      Measure:Progression free survival (PFS)
      Time Frame:upto 12 months
      Safety Issue:No
      Description:
      Measure:Objective response rate (ORR)
      Time Frame:upto 12 months
      Safety Issue:No
      Description:

      Trial Keywords