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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) logo

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)

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

Trial contacts and locations

39

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Central trial contact

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com; First line of the email MUST contain NCT # and Site #.

Data sourced from clinicaltrials.gov

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