BMS-CA001-050

Key Outcome parameters

Assess the safety and tolerability and PFS

Intervention

Main study: Study treatment can consist of the following:

• BMS-986012 Concentrate for Solution for Infusion
• Nivolumab (BMS-936558) Solution for Injection
• Carboplatin
• Etoposide

PET study:

• BMS-986279 IV Injection followed by 4 PET scans

Key inclusion criteria

• Histologically or cytologically documented extensive-stage small cell lung cancer (ES-SCLC) and extensive-stage disease
• 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
• Performance status (ECOG PS) 0 or 1
• At least 1 measurable lesion by computed tomography (CT) or magnetic resonance imaging (MRI)
• Adequate hematologic and end organ function
• Must agree to follow specific methods of contraception, if applicable

Key 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