A Randomized, Open Label Phase II Clinical Trial of BMS-986012 in Combination with Carboplatin, Etoposide and Nivolumab as First-line Therapy in Extensive-Stage Small Cell Lung Cancer

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-510700-36-00

Acronym

CA001-050

Enrollment

135

Registered

2024-06-06

Start date

2021-06-01

Completion date

2025-09-30

Last updated

2025-11-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Extensive-stage Small Cell Lung Cancer

Brief summary

Incidence of adverse events (AEs), Incidence of serious adverse events (SAEs), Incidence of AEs leading to discontinuation, Incidence of deaths, Progression-free survival (PFS) by blinded independent central review (BICR) based on Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria

Detailed description

1. Progression-free survival rate (PFSR) [PFS by BICR based on RECIST v1.1 criteria], PFS by investigator based on RECIST v1.1 criteria, PFSR at 6 and 12 months. PFS by investigator based on RECIST v1.1 criteria., Objective response rate (ORR) based on RECIST v1.1 criteria, Time to response (TTR) based on RECIST v1.1 criteria, Duration of response (DOR) based on RECIST v1.1 criteria, Overall survival (OS), Overall survival rate (OSR), Immunogenicity of BMS-986012 measured by assessment of the presence of specific anti-drug antibodies (ADAs) to BMS-986012 (i.e. incidence of positive ADAs)

Interventions

DRUGOPDIVO 10 mg/mL concentrate for solution for infusion.

DRUGAnti-Fucosyl GM1 PET Tracer

DRUGETOPOSIDE

DRUGCARBOPLATIN

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Incidence of adverse events (AEs), Incidence of serious adverse events (SAEs), Incidence of AEs leading to discontinuation, Incidence of deaths, Progression-free survival (PFS) by blinded independent central review (BICR) based on Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria	—

Secondary

Measure	Time frame
1. Progression-free survival rate (PFSR) [PFS by BICR based on RECIST v1.1 criteria], PFS by investigator based on RECIST v1.1 criteria, PFSR at 6 and 12 months. PFS by investigator based on RECIST v1.1 criteria., Objective response rate (ORR) based on RECIST v1.1 criteria, Time to response (TTR) based on RECIST v1.1 criteria, Duration of response (DOR) based on RECIST v1.1 criteria, Overall survival (OS), Overall survival rate (OSR), Immunogenicity of BMS-986012 measured by assessment of the presence of specific anti-drug antibodies (ADAs) to BMS-986012 (i.e. incidence of positive ADAs)	—

Measure

Time frame

—

Countries

Belgium, Greece, Italy, Netherlands, Poland, Romania, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026