A Randomized, Double-Blind, Multicenter Phase 3 Trial of BMS-986489 (BMS-986012 + Nivolumab Fixed Dose Combination) in Combination with Carboplatin plus Etoposide vs Atezolizumab in Combination with Carboplatin plus Etoposide as First-line Therapy in Participants with Extensive-Stage Small Cell Lung Cancer.
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 530
- 试验地点
- 5
- 主要终点
- To compare the Overall Survival of participants with ES-SCLC randomized to Arm A and Arm B.
研究概览
简要总结
The purpose of this study is to measure the overall survival benefit of BMS 986489 with 4 cycles of chemotherapy followed by BMS 986489 maintenance compared with atezolizumab with 4 cycles of chemotherapy followed by atezolizumab maintenance as first line therapy in participants with ES-SCLC Study details include the following
1 Study Duration Up to 5 years from randomization of the last participant or until the final date on which the data for primary endpoint OS are collected whichever occurs later
2 Study Intervention Duration Participants will be treated until investigator assessed radiographic disease progression by RECIST v1.1 unacceptable toxicity death or withdrawal of consent whichever comes first
3 Study Visit Frequency Every 3 weeks for 4 cycles during induction followed by every 4weeks during maintenance
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
To compare the Overall Survival of participants with ES-SCLC randomized to Arm A and Arm B.
时间窗: From randomization until death from any cause.
次要结局
- 1 To compare time to disease-related symptom deterioration(2 To assess safety)
研究者
Shilpi Sinha
Bristol Myers Squibb India Pvt Ltd