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

Bristol-Myers Squibb (BMS)

Status and phase: Active, not recruiting; Phase 2

Conditions: Extensive-stage Small Cell Lung Cancer

Treatments: Drug: Etoposide; Drug: Carboplatin; Biological: BMS-986012; Biological: Nivolumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT04702880

U1111-1250-4427 (Registry Identifier)

CA001-050

2020-001863-10 (EudraCT Number)

Details and patient eligibility

About

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).

Enrollment: 120 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 2 patient groups

Arm A: Carboplatin + Etoposide + Nivolumab + BMS-986012

Experimental group

Treatment:

Biological: Nivolumab

Drug: Carboplatin

Biological: BMS-986012

Drug: Etoposide

Arm B: Carboplatin + Etoposide + Nivolumab

Experimental group

Treatment:

Biological: Nivolumab

Drug: Carboplatin

Drug: Etoposide