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

• Status: Active, not recruiting
• Trial end date: 2022-01-28
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bristol-Myers Squibb
• Collaborator: Ono Pharmaceutical Co. Ltd
• Treatments: Amrubicin; Antibodies, Monoclonal; Nivolumab; Topotecan

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