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

Purpose

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

Condition

  • Lung Cancer

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
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

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Arm A Nivolumab 		Nivolumab intravenous infusion as specified
  • Drug: Nivolumab
Active Comparator
Arm B Chemotherapy Topotecan 		Topotecan as specified
  • 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)
  • Drug: Amrubicin

Recruiting Locations

More Details

NCT ID
NCT02481830
Status
Completed
Sponsor
Bristol-Myers Squibb