Effectiveness Study of Nivolumab Compared to Chemotherapy in Patients With Relapsed Small-cell Lung Cancer (CheckMate331)

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 3

Conditions: Lung Cancer

Treatments: Drug: Nivolumab; Drug: Topotecan; Drug: Amrubicin

Study type: Interventional

Funder types: Industry

Identifiers

NCT02481830

2015-001097-18 (EudraCT Number)

CA209-331

Details and patient eligibility

About

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

Enrollment: 569 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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569 participants in 3 patient groups

Arm A Nivolumab

Experimental group

Description:

Nivolumab intravenous infusion as specified

Treatment:

Drug: Nivolumab

Arm B Chemotherapy Topotecan

Active Comparator group

Description:

Topotecan as specified

Treatment:

Drug: Topotecan

Arm B Chemotherapy Amrubicin

Active Comparator group

Description:

Amrubicin intravenous infusion as specified (upon investigator's choice, where locally approved for 2nd line SCLC treatment)

Treatment:

Drug: Amrubicin