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).
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
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There are 43 Locations for this study
Birmingham Alabama, 35233, United States
Lexington Kentucky, 40503, United States
Hackensack New Jersey, 07601, United States
Durham North Carolina, 27710, United States
Cincinnati Ohio, 45219, United States
Cleveland Ohio, 44106, United States
Nashville Tennessee, 37203, United States
Westmead New South Wales, 2145, Australia
Greenslopes Queensland, 4120, Australia
Ballarat Central Victoria, 3350, Australia
Malvern Victoria, 3144, Australia
Murdoch Western Australia, 6150, Australia
Edmonton Alberta, T6G 1, Canada
Brampton Ontario, L6R 3, Canada
Heraklion Irakleío, 715 0, Greece
Athens , 11527, Greece
Athens , 185 4, Greece
Peschiera del Garda , 37019, Italy
Pisa , 56124, Italy
Rozzano , 20089, Italy
Sendai Miyagi, 980-0, Japan
Osaka-Sayama City Osaka, 589-8, Japan
Takatsuki Osaka, 56986, Japan
Ina-machi Saitama, 362-0, Japan
Gdansk , 80-21, Poland
Łódź , 93-33, Poland
Bucharest , 02232, Romania
Cluj , 40001, Romania
Craiova , 20054, Romania
Barcelona , 08035, Spain
Madrid , 28041, Spain
Majadahonda , 28222, Spain
Málaga , 29010, Spain
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