A Study of BMS-986012 in Combination With Carboplatin, Etoposide, and Nivolumab as First-line Therapy in Extensive-stage Small Cell Lung Cancer
NCT ID: NCT04702880
Last Updated: 2025-10-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE2
120 participants
INTERVENTIONAL
2021-03-17
2025-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Arm A: Carboplatin + Etoposide + Nivolumab + BMS-986012
BMS-986012
Specified dose on specified days
Carboplatin
Specified dose on specified days
Etoposide
Specified dose on specified days
Nivolumab
Specified dose on specified days
Arm B: Carboplatin + Etoposide + Nivolumab
Carboplatin
Specified dose on specified days
Etoposide
Specified dose on specified days
Nivolumab
Specified dose on specified days
Interventions
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BMS-986012
Specified dose on specified days
Carboplatin
Specified dose on specified days
Etoposide
Specified dose on specified days
Nivolumab
Specified dose on specified days
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Bristol-Myers Squibb
INDUSTRY
Responsible Party
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Principal Investigators
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Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
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Local Institution - 0075
Birmingham, Alabama, United States
Local Institution - 0022
Hackensack, New Jersey, United States
Local Institution - 0002
Durham, North Carolina, United States
Local Institution - 0060
Cincinnati, Ohio, United States
Local Institution
Cincinnati, Ohio, United States
Local Institution - 0067
Cleveland, Ohio, United States
Local Institution - 0081
Nashville, Tennessee, United States
Local Institution
Dallas, Texas, United States
Local Institution - 0003
Westmead, New South Wales, Australia
Local Institution - 0023
Greenslopes, Queensland, Australia
Local Institution - 0001
Malvern, Victoria, Australia
Local Institution - 0004
Murdoch, Western Australia, Australia
Local Institution - 0051
Charleroi, Hainaut, Belgium
Local Institution - 0034
Ghent, , Belgium
Local Institution - 0050
Liège, , Belgium
Local Institution - 0012
Edmonton, Alberta, Canada
Local Institution - 0064
Brampton, Ontario, Canada
Local Institution - 0045
Heraklion, Irakleío, Greece
Local Institution - 0036
Athens, , Greece
Local Institution - 0038
Athens, , Greece
Local Institution - 0030
Peschiera del Garda, , Italy
Local Institution - 0031
Pisa, , Italy
Local Institution - 0029
Rozzano, , Italy
Local Institution - 0073
Sendai, Miyagi, Japan
Local Institution - 0070
Ōsaka-sayama, Osaka, Japan
Local Institution - 0069
Takatsuki, Osaka, Japan
Local Institution - 0077
Ina-machi, Saitama, Japan
Local Institution - 0039
Amsterdam, North Holland, Netherlands
Local Institution - 0066
Arnhem, , Netherlands
Local Institution - 0040
Groningen, , Netherlands
Local Institution - 0049
Gdansk, , Poland
Local Institution - 0048
Lodz, , Poland
Local Institution - 0043
Bucharest, , Romania
Local Institution - 0042
Cluj-Napoca, , Romania
Local Institution - 0041
Craiova, , Romania
Local Institution - 0007
Barcelona, Barcelona [Barcelona], Spain
Local Institution - 0021
Madrid, , Spain
Local Institution - 0005
Majadahonda, , Spain
Local Institution - 0006
Málaga, , Spain
Countries
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References
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Chu Q, Leighl NB, Surmont V, van Herpen C, Sibille A, Markman B, Clarke S, Juergens RA, Rivera MA, Andelkovic V, Rudin CM, Snow S, Kim DW, Sanatani M, Lin H, Sanghavi K, Tannenbaum-Dvir S, Basciano P, Lathers D, Urbanska K, Kollia G, He C, DiPiero A, Liu Y, Ready N. BMS-986012, an Anti-Fucosyl-GM1 Monoclonal Antibody as Monotherapy or in Combination With Nivolumab in Relapsed/Refractory SCLC: Results From a First-in-Human Phase 1/2 Study. JTO Clin Res Rep. 2022 Aug 27;3(11):100400. doi: 10.1016/j.jtocrr.2022.100400. eCollection 2022 Nov.
Related Links
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BMS Clinical Trial Information
BMS Clinical Trial Patient Recruiting
Other Identifiers
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2020-001863-10
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
U1111-1250-4427
Identifier Type: REGISTRY
Identifier Source: secondary_id
CA001-050
Identifier Type: -
Identifier Source: org_study_id
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