A Study of BMS-986012 in Combination With Carboplatin, Etoposide, and Nivolumab as First-line Therapy in Extensive-stage Small Cell Lung Cancer

• Status: Recruiting
• Trial end date: 2024-09-07
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bristol-Myers Squibb
• Treatments: Carboplatin; Etoposide; Nivolumab

Criteria

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