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

Sponsor: Bristol-Myers Squibb

Sponsor score: 60
Inactive

ClinicalTrials ID:NCT04702880

Patient View

This study evaluates the safety and efficacy of BMS-986012 with carboplatin, etoposide, and nivolumab in ES-SCLC. Eligible participants must have Stage IV ES-SCLC, ECOG PS 0-1, and measurable lesions. Interventions include specified doses of BMS-986012, carboplatin, etoposide, and nivolumab. Adequate organ function and adherence to contraception methods are required.

Patient Parameters

Program Overview

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).

Eligibility Criteria

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

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