A Study of BMS-986012 in Combination With Carboplatin, Etoposide, and Nivolumab as First-line Therapy in Extensive-stage Small Cell Lung Cancer

April 24, 2026 updated by: Bristol-Myers Squibb

A Randomized, Open-label Phase 2 Clinical Trial of BMS-986012 in Combination With Carboplatin, Etoposide, and Nivolumab as First-line Therapy in Extensive-stage Small Cell Lung Cancer

The purpose of this study is to demonstrate that treatment with BMS-986012 in combination with carboplatin, etoposide, and nivolumab will have acceptable safety and tolerability and will improve progression-free survival compared with carboplatin, etoposide, and nivolumab alone in newly diagnosed participants with extensive-stage small cell lung cancer (ES-SCLC).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

135

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • Westmead, New South Wales, Australia, 2145
        • Local Institution - 0003
    • Queensland
      • Greenslopes, Queensland, Australia, 4120
        • Local Institution - 0023
    • Victoria
      • Malvern, Victoria, Australia, 3144
        • Local Institution - 0001
    • Western Australia
      • Murdoch, Western Australia, Australia, 6150
        • Local Institution - 0004
  • Belgium
      • Ghent, Belgium, 9000
        • Local Institution - 0034
      • Liège, Belgium, 4000
        • Local Institution - 0050
    • Hainaut
      • Charleroi, Hainaut, Belgium, 6060
        • Local Institution - 0051
  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T6G 1Z2
        • Local Institution - 0012
    • Ontario
      • Brampton, Ontario, Canada, L6R 3J7
        • Local Institution - 0064
  • Greece
      • Athens, Greece, 11527
        • Local Institution - 0036
      • Athens, Greece, 185 47
        • Local Institution - 0038
    • Irakleío
      • Heraklion, Irakleío, Greece, 715 00
        • Local Institution - 0045
  • Italy
      • Peschiera del Garda, Italy, 37019
        • Local Institution - 0030
      • Pisa, Italy, 56124
        • Local Institution - 0031
      • Rozzano, Italy, 20089
        • Local Institution - 0029
  • Japan
    • Miyagi
      • Sendai, Miyagi, Japan, 980-0873
        • Local Institution - 0073
    • Osaka
      • Takatsuki, Osaka, Japan, 5698686
        • Local Institution - 0069
      • Ōsaka-sayama, Osaka, Japan, 589-8511
        • Local Institution - 0070
    • Saitama
      • Ina-machi, Saitama, Japan, 362-0806
        • Local Institution - 0077
  • Netherlands
      • Arnhem, Netherlands, 6815 AD
        • Local Institution - 0066
      • Groningen, Netherlands, 9700RB
        • Local Institution - 0040
    • North Holland
      • Amsterdam, North Holland, Netherlands, 1081 HV
        • Local Institution - 0039
  • Poland
      • Gdansk, Poland, 80-214
        • Local Institution - 0049
      • Lodz, Poland, 93-338
        • Local Institution - 0048
  • Romania
      • Bucharest, Romania, 022328
        • Local Institution - 0043
      • Cluj-Napoca, Romania, 400015
        • Local Institution - 0042
      • Craiova, Romania, 200542
        • Local Institution - 0041
  • Spain
      • Madrid, Spain, 28041
        • Local Institution - 0021
      • Majadahonda, Spain, 28222
        • Local Institution - 0005
      • Málaga, Spain, 29010
        • Local Institution - 0006
    • Barcelona [Barcelona]
      • Barcelona, Barcelona [Barcelona], Spain, 08035
        • Local Institution - 0007
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35249
        • Local Institution - 0075
    • New Jersey
      • Hackensack, New Jersey, United States, 07601
        • Local Institution - 0022
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Local Institution - 0002
    • Ohio
      • Cincinnati, Ohio, United States, 45267
        • Local Institution
      • Cincinnati, Ohio, United States, 45267
        • Local Institution - 0060
      • Cleveland, Ohio, United States, 44106-1716
        • Local Institution - 0067
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • Local Institution - 0081
    • Texas
      • Dallas, Texas, United States, 75390
        • Local Institution

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Histologically or cytologically documented extensive-stage small cell lung cancer (ES-SCLC) and extensive-stage disease (American Joint Committee on Cancer, 8th edition, Stage IV [T any, N any, M1a, M1b, or M1c], or T3-4 due to multiple lung nodules that are too extensive or tumor or nodal volume that is too large to be encompassed in a tolerable radiation plan)
  • Participants taking part in the separate PET tracer sub-study must provide a fresh tumor biopsy from any disease site (primary or metastatic)
  • Archived tumor specimens, in the form of blocks or sectioned slides, are mandatory for all participants except those participating in the separate PET tracer sub-study for whom the archived tumor specimen is optional
  • Eastern Cooperative Oncology Group performance status (ECOG PS) 0 or 1
  • At least 1 measurable lesion by computed tomography (CT) or magnetic resonance imaging (MRI) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) criteria
  • Adequate hematologic and end organ function
  • Must agree to follow specific methods of contraception, if applicable

Exclusion Criteria:

  • Women who are pregnant or breastfeeding. Japan only: participation in the study is not allowed even if breastfeeding is suspended
  • Prior chemotherapy, radiation therapy, or biologic therapy for SCLC. Previously treated limited stage SCLC (LS-SCLC) participants are also excluded
  • Symptomatic brain or other central nervous system (CNS) metastases
  • Paraneoplastic autoimmune syndrome requiring systemic treatment
  • History of idiopathic pulmonary fibrosis, drug-induced pneumonitis, idiopathic pneumonitis, organizing pneumonia, or evidence of active pneumonitis on screening chest CT scan
  • Grade ≥ 2 peripheral sensory neuropathy at study entry
  • Significant uncontrolled cardiovascular disease
  • Active, known or suspected autoimmune disease or inflammatory disorder

Other protocol-defined inclusion/exclusion criteria apply

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm A: Carboplatin + Etoposide + Nivolumab + BMS-986012
Biological: Nivolumab
Specified dose on specified days
Other Names:
  • BMS-936558
Drug: Carboplatin
Specified dose on specified days
Biological: BMS-986012
Specified dose on specified days
Other Names:
  • Fucosyl-GM1 Antibody
Drug: Etoposide
Specified dose on specified days
Experimental: Arm B: Carboplatin + Etoposide + Nivolumab
Biological: Nivolumab
Specified dose on specified days
Other Names:
  • BMS-936558
Drug: Carboplatin
Specified dose on specified days
Drug: Etoposide
Specified dose on specified days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence of adverse events (AEs)
Time Frame: Up to 2 years and 100 days
Up to 2 years and 100 days
Incidence of serious adverse events (SAEs)
Time Frame: Up to 2 years and 128 days
Up to 2 years and 128 days
Incidence of AEs leading to discontinuation
Time Frame: Up to 2 years and 128 days
Up to 2 years and 128 days
Incidence of deaths
Time Frame: Up to 2 years and 128 days
Up to 2 years and 128 days
Progression-free survival (PFS) by blinded independent central review (BICR) based on Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria
Time Frame: Up to 2 years
Up to 2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression-free survival rate (PFSR)
Time Frame: 6 and 12 months
PFS by BICR based on RECIST v1.1 criteria
6 and 12 months
PFS by investigator based on RECIST v1.1 criteria
Time Frame: Up to 2 years
Up to 2 years
PFSR
Time Frame: 6 and 12 months
PFS by investigator based on RECIST v1.1 criteria
6 and 12 months
Objective response rate (ORR) based on RECIST v1.1 criteria
Time Frame: Up to 2 years
Up to 2 years
Time to response (TTR) based on RECIST v1.1 criteria
Time Frame: Up to 2 years
Up to 2 years
Duration of response (DOR) based on RECIST v1.1 criteria
Time Frame: Up to 2 years
Up to 2 years
Overall survival (OS)
Time Frame: Up to 3 years
By arm
Up to 3 years
Overall survival rate (OSR)
Time Frame: Up to 3 years
By arm
Up to 3 years
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)
Time Frame: Up to 2 years
Up to 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bristol-Myers Squibb

Investigators

  • Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 17, 2021

Primary Completion (Actual)

May 22, 2025

Study Completion (Actual)

November 28, 2025

Study Registration Dates

First Submitted

January 7, 2021

First Submitted That Met QC Criteria

January 7, 2021

First Posted (Actual)

January 11, 2021

Study Record Updates

Last Update Posted (Actual)

April 29, 2026

Last Update Submitted That Met QC Criteria

April 24, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CA001-050
  • 2020-001863-10 (EudraCT Number)
  • U1111-1250-4427 (Registry Identifier: WHO)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myer Squibb's data sharing policy and process can be found at https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html

IPD Sharing Time Frame

See Plan Description

IPD Sharing Access Criteria

See Plan Description

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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