A Randomized Study of BMS-986012 in Combination with Carboplatin, Etoposide, and Nivolumab in Participants with Extensive-stage Small Cell Lung Cancer (CA001050)

Active, not recruiting

Recruitment & Eligibility

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)
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
Prior chemotherapy, radiation therapy, or biologic therapy for small cell lung cancer (SCLC) for first-line treatment. 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

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method