A Randomized Study of BMS-986012 in Combination with Carboplatin, Etoposide, and Nivolumab in Participants with Extensive-stage Small Cell Lung Cancer
- Conditions
- Extensive-stage Small Cell Lung Cancer
- Registration Number
- JPRN-jRCT2051210111
- Lead Sponsor
- Tannenbaum-Dvir Sarah
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 10
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
- 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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method - Incidence of adverse events (AEs) [ Time Frame: Up to 2 years and 100 days ]<br>- Incidence of serious adverse events (SAEs) [ Time Frame: Up to 2 years and 128 days ]<br>- Incidence of AEs leading to discontinuation [ Time Frame: Up to 2 years and 128 days ]<br>- Incidence of deaths [ Time Frame: Up to 2 years and 128 days ]<br>- 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 Outcome Measures
Name Time Method - Progression-free survival rate (PFSR) [ Time Frame: 6 and 12 months ]. PFS by BICR based on RECIST v1.1 criteria<br>- PFS by investigator based on RECIST v1.1 criteria [ Time Frame: Up to 2 years ]<br>- PFSR [ Time Frame: 6 and 12 months ]. PFS by investigator based on RECIST v1.1 criteria<br>- Objective response rate (ORR) based on RECIST v1.1 criteria [ Time Frame: Up to 2 years ]<br>- Time to response (TTR) based on RECIST v1.1 criteria [ Time Frame: Up to 2 years ]<br>- Duration of response (DOR) based on RECIST v1.1 criteria [ Time Frame: Up to 2 years ]<br>- Overall survival (OS) [ Time Frame: Up to 3 years ]. By arm<br>- Overall survival rate (OSR) [ Time Frame: Up to 3 years ]. By arm<br>- 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 ]