Status:
ACTIVE_NOT_RECRUITING
A Study of BMS-986012 in Combination With Carboplatin, Etoposide, and Nivolumab as First-line Therapy in Extensive-stage Small Cell Lung Cancer
Lead Sponsor:
Bristol-Myers Squibb
Conditions:
Extensive-stage Small Cell Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 progr...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 17 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2025
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT04702880
Start Date
March 17 2021
End Date
December 31 2025
Last Update
October 8 2025
Active Locations (39)
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1
Local Institution - 0075
Birmingham, Alabama, United States, 35249
2
Local Institution - 0022
Hackensack, New Jersey, United States, 07601
3
Local Institution - 0002
Durham, North Carolina, United States, 27710
4
Local Institution - 0060
Cincinnati, Ohio, United States, 45267