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A Randomized, Open-label Phase 2 Clinical Trial of BMS-986012 in Combination with Carboplatin, Etoposide, and Nivolumab as First-line Therapy in Extensive-stage Small Cell Lung Cancer

A Randomized Study of BMS-986012 in Combination with Carboplatin, Etoposide, and Nivolumab in Participants with Extensive-stage Small Cell Lung Cancer (CA001050)

Tannenbaum-Dvir Sarah

Bristol-Myers Squibb

1-2-1 Otemachi, Chiyoda-ku, Tokyo

mg-jp-clinical_trial@bms.com

Tannenbaum-Dvir Sarah

Bristol-Myers Squibb

1-2-1 Otemachi, Chiyoda-ku, Tokyo

+81-120-093-507

MG-JP-RCO-JRCT@bms.com

Not Recruiting

Oct. 29, 2021

Interventional

randomized controlled trial

open(masking not used)

active control

parallel assignment

treatment purpose

- 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

Both

Extensive-stage Small Cell Lung Cancer

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 days
4. Biological: Nivolumab. Specified dose on specified days. Other Name: BMS-936558

- 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 ]

- 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 ]

+81-72-683-1221

Oct. 04, 2021

No

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