Lung Cancer Clinical Trial

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

Summary

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).

View Eligibility Criteria

Eligibility Criteria

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 is for people with:

Lung Cancer

Phase:

Phase 2

Estimated Enrollment:

120

Study ID:

NCT04702880

Recruitment Status:

Recruiting

Sponsor:

Bristol-Myers Squibb

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There are 43 Locations for this study

See Locations Near You

Local Institution - 0075
Birmingham Alabama, 35233, United States
Local Institution
Lexington Kentucky, 40503, United States
Local Institution - 0022
Hackensack New Jersey, 07601, United States
Local Institution - 0002
Durham North Carolina, 27710, United States
Local Institution - 0060
Cincinnati Ohio, 45219, United States
Local Institution
Cincinnati Ohio, 45267, United States More Info
Site 0059
Contact
Local Institution - 0067
Cleveland Ohio, 44106, United States
Local Institution - 0081
Nashville Tennessee, 37203, United States
Local Institution
Dallas Texas, 75390, United States More Info
Site 0057
Contact
Local Institution - 0003
Westmead New South Wales, 2145, Australia
Local Institution - 0023
Greenslopes Queensland, 4120, Australia
Local Institution - 0078
Ballarat Central Victoria, 3350, Australia
Local Institution - 0001
Malvern Victoria, 3144, Australia
Local Institution - 0004
Murdoch Western Australia, 6150, Australia
Grand Hôpital de Charleroi-Oncology & Hematology
Charleroi , 6000, Belgium More Info
Benoit Colinet, Site 0051
Contact
+3271104701
Local Institution - 0034
Gent , 9000, Belgium More Info
Site 0034
Contact
CHU de Liège
Liège , 4000, Belgium More Info
Anne Sibille, Site 0050
Contact
003243237400
Local Institution - 0012
Edmonton Alberta, T6G 1, Canada
Local Institution - 0064
Brampton Ontario, L6R 3, Canada
Local Institution - 0045
Heraklion Irakleío, 715 0, Greece
Local Institution - 0036
Athens , 11527, Greece
Local Institution - 0038
Athens , 185 4, Greece
Local Institution - 0030
Peschiera del Garda , 37019, Italy
Local Institution - 0031
Pisa , 56124, Italy
Humanitas-U.O di Oncologia medica ed Ematologia
Rozzano , 20089, Italy
Local Institution - 0073
Sendai Miyagi, 980-0, Japan
Local Institution - 0070
Osaka-Sayama City Osaka, 589-8, Japan
Local Institution - 0069
Takatsuki Osaka, 56986, Japan
Local Institution - 0077
Ina-machi Saitama, 362-0, Japan
Vrije Universiteit University Medical Centre-Pulmonology
Amsterdam , 1081 , Netherlands More Info
I Bahce, Site 0039
Contact
31204444782
Rijnstate Ziekenhuis
Arnhem , 6815 , Netherlands More Info
Niels Claessens, Site 0066
Contact
31880056730
Local Institution - 0040
Groningen , 9700R, Netherlands More Info
Site 0040
Contact
Local Institution - 0079
Leiden , 2333 , Netherlands More Info
Site 0079
Contact
Local Institution
Nijmegen , 6500 , Netherlands More Info
Site 0052
Contact
Local Institution - 0049
Gdansk , 80-21, Poland
Local Institution - 0048
Łódź , 93-33, Poland
Local Institution - 0043
Bucharest , 02232, Romania
Local Institution - 0042
Cluj , 40001, Romania
Local Institution - 0041
Craiova , 20054, Romania
Local Institution - 0007
Barcelona Barcelona [Barcelona], 08035, Spain
Local Institution - 0021
Madrid , 28041, Spain
Local Institution - 0005
Majadahonda , 28222, Spain
Local Institution - 0006
Málaga , 29010, Spain

How clear is this clinincal trial information?

Study is for people with:

Lung Cancer

Phase:

Phase 2

Estimated Enrollment:

120

Study ID:

NCT04702880

Recruitment Status:

Recruiting

Sponsor:


Bristol-Myers Squibb

How clear is this clinincal trial information?

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