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
Recruiting
