Health Condition 1: C348- Malignant neoplasm of overlappingsites of bronchus and lung
Conditions
Interventions
Intervention1: Drug/BMS-986489(BMS-986012 + nivolumab FDC)/Solution for Injection: 70mgof BMS-986012and 60 mg of Nivolumab per mL.
IMP Open Label
Provided centrally by the Sponsor
Each container will
Sponsors
Bristol Myers Squibb India Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: Participant must be at least 18 years of age or local age of majority at the time of signing the ICF Participants must have histologically or cytologically documented SCLC Participants must have extensive stage disease Stage IV 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 must have at least 1 measurable lesion outside the central nervous system by computed tomography or magnetic resonance imaging per RECIST v1.1 criteria Participants who have received prior chemotherapy/chemoradiotherapy for LS SCLC are eligible if treatment was completed at least 6 months prior to initiating study treatment Eastern Cooperative Oncology Group performance status of 0 or 1 Participants must be suitable to receive platinum-based chemotherapy regimen as well as anti PD L 1 based regimens as per locally approved drug labels and institutional guidelines
Exclusion criteria
Exclusion criteria: Prior treatment for ES-SCLC Note Treatment of CNS metastases with local treatment including radiation and or surgery is permitted Untreated symptomatic CNS metastases Leptomeningeal disease Malignancy related superior vena cava syndrome that requires urgent radiation or may require urgent radiation in the immediate future per the Investigator Pleural effusion that cannot be controlled with appropriate interventions Concurrent malignancy Grade less than or equal to 2 peripheral sensory neuropathy Participants with active, known or suspected autoimmune disease Prior treatment with an anti PD 1 anti PD L1 or anti CTLA 4 antibody or any other antibody or drug specifically targeting T cell co stimulation or checkpoint pathways Prior treatment with an anti fuc GM1 therapy or any other drug specifically targeting fucosyl GM1
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To compare the Overall Survival of participants with ES-SCLC randomized to Arm A and Arm B.Timepoint: From randomization until death from any cause. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1 To compare time to disease-related symptom deterioration 2 To assess safety 3 Objective response as assessed by the investigator 4 Estimate Duration of response as assessed by the investigator 5 Progression free survival as assessed by the investigatorTimepoint: 1)Time to definitive deterioration (LCSS ASBI)-Time from randomization to a clinically meaningful decline (more than or equal to 10-point increase from baseline). 2)Incidence of AEs-Includes AEs, SAEs, AEs leading to discontinuation, & death. 3)OR-Best overall response of CR or PR. 4)DOR-Time from first response to PFS event. 5)PFS-Time from randomization to first documented progression or death. | — |
Countries
Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Czech Republic, France, Germany, Greece, India, Italy, Japan, Malaysia, Mexico, Netherlands, Poland, Republic of Korea, Romania, Spain, Switzerland, Turkey, United Kingdom, United States of America
Contacts
Public ContactShilpi Sinha
Bristol Myers Squibb India Pvt Ltd
Outcome results
None listed