For more information regarding Bristol-Myers Squibb Clinical Trial participation, please
visit www.BMSStudyConnect.com
Inclusion Criteria:
- Histologically or cytologically documented extensive-stage small cell lung cancer
(ES-SCLC) and extensive-stage disease (American Joint Committee on Cancer, 7th
edition, Stage IV [T any, N any, M1a, or M1b], 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)
- Must provide a fresh tumor biopsy from the primary disease site (when possible) or
from any metastatic site when the primary site is not available
- 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 (Response
Evaluation Criteria in Solid Tumors (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
- 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
Active, Not Recruiting
