Extensive-stage Small Cell Lung Cancer
Conditions
Keywords
BMS-986012, Carboplatin, Etoposide, Extensive-stage small cell lung cancer, Fucosyl, Nivolumab, Targeted SCLC therapy
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).
Interventions
DRUGEtoposide
Specified dose on specified days
BIOLOGICALNivolumab
Specified dose on specified days
DRUGCarboplatin
Specified dose on specified days
BIOLOGICALBMS-986012
Specified dose on specified days
Sponsors
Bristol-Myers Squibb
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 |
| 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Duration of response (DOR) based on RECIST v1.1 criteria | Up to 2 years | — |
| Overall survival (OS) | Up to 3 years | By arm |
| Progression-free survival rate (PFSR) | 6 and 12 months | PFS by BICR based on RECIST v1.1 criteria |
| 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 rate (OSR) | Up to 3 years | By arm |
| 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 | — |
| Time to response (TTR) based on RECIST v1.1 criteria | Up to 2 years | — |
Countries
Australia, Belgium, Canada, Greece, Italy, Japan, Netherlands, Poland, Romania, Spain, United States
Outcome results
None listed