A Study of BMS-986012 in Combination With Carboplatin, Etoposide, and Nivolumab as First-line Therapy in Extensive-stage Small Cell Lung Cancer
- Conditions
- Extensive-stage Small Cell Lung Cancer
- Interventions
- Registration Number
- NCT04702880
- Lead Sponsor
- Bristol-Myers Squibb
- Brief 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 120
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm A: Carboplatin + Etoposide + Nivolumab + BMS-986012 BMS-986012 - Arm A: Carboplatin + Etoposide + Nivolumab + BMS-986012 Etoposide - Arm A: Carboplatin + Etoposide + Nivolumab + BMS-986012 Nivolumab - Arm B: Carboplatin + Etoposide + Nivolumab Carboplatin - Arm B: Carboplatin + Etoposide + Nivolumab Etoposide - Arm B: Carboplatin + Etoposide + Nivolumab Nivolumab - Arm A: Carboplatin + Etoposide + Nivolumab + BMS-986012 Carboplatin -
- Primary Outcome Measures
Name Time Method Progression-free survival (PFS) by blinded independent central review (BICR) based on Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria Up to 2 years Incidence of adverse events (AEs) Up to 2 years and 100 days Incidence of serious adverse events (SAEs) Up to 2 years and 128 days Incidence of AEs leading to discontinuation Up to 2 years and 128 days Incidence of deaths Up to 2 years and 128 days
- Secondary Outcome Measures
Name Time Method Time to response (TTR) based on RECIST v1.1 criteria Up to 2 years Duration of response (DOR) based on RECIST v1.1 criteria Up to 2 years Progression-free survival rate (PFSR) 6 and 12 months PFS by BICR based on RECIST v1.1 criteria
PFS by investigator based on RECIST v1.1 criteria Up to 2 years PFSR 6 and 12 months PFS by investigator based on RECIST v1.1 criteria
Objective response rate (ORR) based on RECIST v1.1 criteria Up to 2 years Overall survival rate (OSR) Up to 3 years By arm
Immunogenicity of BMS-986012 measured by assessment of the presence of specific anti-drug antibodies (ADAs) to BMS-986012 (i.e. incidence of positive ADAs) Up to 2 years Overall survival (OS) Up to 3 years By arm
Trial Locations
- Locations (38)
Local Institution - 0075
🇺🇸Birmingham, Alabama, United States
Local Institution - 0022
🇺🇸Hackensack, New Jersey, United States
Local Institution - 0002
🇺🇸Durham, North Carolina, United States
Local Institution - 0060
🇺🇸Cincinnati, Ohio, United States
Local Institution
🇺🇸Dallas, Texas, United States
Local Institution - 0067
🇺🇸Cleveland, Ohio, United States
Local Institution - 0081
🇺🇸Nashville, Tennessee, United States
Local Institution - 0003
🇦🇺Westmead, New South Wales, Australia
Local Institution - 0023
🇦🇺Greenslopes, Queensland, Australia
Local Institution - 0001
🇦🇺Malvern, Victoria, Australia
Scroll for more (28 remaining)Local Institution - 0075🇺🇸Birmingham, Alabama, United States