Extensive-stage Small Cell Lung Cancer
Conditions
Interventions
1. Biological: BMS-986012. Specified dose on specified days. Other Name: Fucosyl-GM1 Antibody
2. Drug: Carboplatin. Specified dose on specified days
3. Drug: Etoposide. Specified dose on specified day
Sponsors
Tannenbaum-Dvir Sarah
Eligibility
Sex/Gender
All
Inclusion 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) - 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
Exclusion criteria: - Women who are pregnant or breastfeeding - Prior chemotherapy, radiation therapy, or biologic therapy for small cell lung cancer (SCLC) for first-line treatment. 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| - Incidence of adverse events (AEs) [ Time Frame: Up to 2 years and 100 days ] - Incidence of serious adverse events (SAEs) [ Time Frame: Up to 2 years and 128 days ] - Incidence of AEs leading to discontinuation [ Time Frame: Up to 2 years and 128 days ] - Incidence of deaths [ Time Frame: 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 [ Time Frame: Up to 2 years ] | — |
Secondary
| Measure | Time frame |
|---|---|
| - Progression-free survival rate (PFSR) [ Time Frame: 6 and 12 months ]. PFS by BICR based on RECIST v1.1 criteria - PFS by investigator based on RECIST v1.1 criteria [ Time Frame: Up to 2 years ] - PFSR [ Time Frame: 6 and 12 months ]. PFS by investigator based on RECIST v1.1 criteria - Objective response rate (ORR) based on RECIST v1.1 criteria [ Time Frame: Up to 2 years ] - Time to response (TTR) based on RECIST v1.1 criteria [ Time Frame: Up to 2 years ] - Duration of response (DOR) based on RECIST v1.1 criteria [ Time Frame: Up to 2 years ] - Overall survival (OS) [ Time Frame: Up to 3 years ]. By arm - Overall survival rate (OSR) [ Time Frame: 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) [ Time Frame: Up to 2 years ] | — |
Countries
Australia, Belgium, Canada, Greece, Italy, Japan, Netherlands, Poland, Romania, Spain, United States
Contacts
Public ContactSarah Tannenbaum-Dvir
Bristol-Myers Squibb
Outcome results
None listed