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 45 Locations for this study

See Locations Near You

University of Alabama at Birmingham
Birmingham Alabama, 35233, United States More Info
Maya Khalil, Site 0075
Contact
205-975-2833
Moffitt Cancer Center
Tampa Florida, 33612, United States More Info
alberto chiappori, Site 0061
Contact
813-484-1138
Local Institution
Lexington Kentucky, 40503, United States
John Theurer Cancer Center
Hackensack New Jersey, 07601, United States More Info
Martin Gutierrez, Site 0022
Contact
551-996-5863
Duke Cancer Institute
Durham North Carolina, 27710, United States More Info
Neal Ready, Site 0002
Contact
919-684-8239
University of Cincinnati Medical Center
Cincinnati Ohio, 45219, United States More Info
Muhammad Riaz, Site 0060
Contact
513-558-2104
Local Institution
Cincinnati Ohio, 45267, United States More Info
Site 0059
Contact
University Hospitals Cleveland Medical Center
Cleveland Ohio, 44106, United States More Info
Afshin Dowlati, Site 0067
Contact
216-844-5181
Tennessee Oncology Nashville
Nashville Tennessee, 37203, United States More Info
Melissa Johnson, Site 0081
Contact
615-329-7274
Local Institution
Dallas Texas, 75390, United States More Info
Site 0057
Contact
MultiCare Health System
Tacoma Washington, 98402, United States More Info
Nehal Masood, Site 0080
Contact
253-403-2391
Local Institution - 0003
Westmead New South Wales, 2145, Australia More Info
Site 0003
Contact
Local Institution - 0023
Greenslopes Queensland, 4120, Australia More Info
Site 0023
Contact
Local Institution
Ballarat Victoria, 3350, Australia More Info
Site 0078
Contact
Local Institution - 0001
Malvern Victoria, 3144, Australia More Info
Site 0001
Contact
Local Institution - 0004
Murdoch Western Australia, 6150, Australia More Info
Site 0004
Contact
Local Institution - 0051
Charleroi , 6000, Belgium More Info
Site 0051
Contact
Local Institution - 0034
Gent , 9000, Belgium More Info
Site 0034
Contact
Local Institution - 0050
Liège , 4000, Belgium More Info
Site 0050
Contact
Local Institution - 0012
Edmonton Alberta, T6G 1, Canada More Info
Site 0012
Contact
Local Institution - 0064
Brampton Ontario, L6R 3, Canada More Info
Site 0064
Contact
Local Institution - 0045
Heraklion Irakleío, 715 0, Greece More Info
Site 0045
Contact
Local Institution - 0036
Athens , 11527, Greece More Info
Site 0036
Contact
Local Institution - 0038
Athens , 185 4, Greece More Info
Site 0038
Contact
Casa di Cura Dott. Pederzoli
Peschiera del Garda , 37019, Italy More Info
ANTONIO SANTO, Site 0030
Contact
0456444843
Local Institution - 0031
Pisa , 56124, Italy More Info
Site 0031
Contact
Humanitas-U.O di Oncologia medica ed Ematologia
Rozzano , 20089, Italy More Info
Armando Santoro, Site 0029
Contact
390282244080
Local Institution - 0073
Sendai Miyagi, 980-0, Japan More Info
Site 0073
Contact
Local Institution - 0070
Osaka-Sayama City Osaka, 589-8, Japan More Info
Site 0070
Contact
Local Institution - 0069
Takatsuki Osaka, 56986, Japan More Info
Site 0069
Contact
Local Institution - 0077
Ina-machi Saitama, 362-0, Japan More Info
Site 0077
Contact
Local Institution - 0039
Amsterdam , 1081 , Netherlands More Info
Site 0039
Contact
Local Institution - 0066
Arnhem , 6815 , Netherlands More Info
Site 0066
Contact
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 More Info
Site 0049
Contact
Local Institution - 0048
Łódź , 93-33, Poland More Info
Site 0048
Contact
Local Institution - 0043
Bucharest , 02232, Romania More Info
Site 0043
Contact
Local Institution - 0042
Cluj , 40001, Romania More Info
Site 0042
Contact
Local Institution - 0041
Craiova , 20054, Romania More Info
Site 0041
Contact
Local Institution - 0007
Barcelona , 08035, Spain More Info
Site 0007
Contact
Local Institution - 0021
Madrid , 28041, Spain More Info
Site 0021
Contact
Local Institution - 0005
Majadahonda , 28222, Spain More Info
Site 0005
Contact
Local Institution - 0006
Málaga , 29010, Spain More Info
Site 0006
Contact

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

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