NCT06646276招募中3 期
A Randomized, Double Blind, Multicenter Phase 3 Trial of BMS-986489 (Atigotatug+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 (TIGOS).
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 530
- 试验地点
- 338
- 主要终点
- Overall Survival (OS)
研究概览
简要总结
The Purpose of the Study is to Compare the Efficacy and Safety of BMS-986489 (Anti-fucosyl-GM1+ Nivolumab Fixed Dose Combination) in Combination with Carboplatin plus Etoposide to that of Atezolizumab with Carboplatin plus Etoposide as First-Line Therapy in Participants with Extensive-Stage Small Cell Lung Cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants must have diagnosis of Extensive-Stage Small Cell Lung Cancer (ES-SCLC).
- •Participants must be Healthy enough to do their normal activities with little or no help based on the ECOG performance scale.
- •Participants must have at least one tumor that can be measured using special imaging techniques like a CT scan or MRI at a site other than the brain and nervous system
排除标准
- •Participants have already received certain types of treatment for extensive stage small cell lung cancer
- •Participants have certain health conditions, like spread of small cell lung cancer to the brain that are causing symptoms, certain lung diseases, heart diseases, infections, autoimmune diseases, other cancers, or a type of nerve damage called peripheral sensory neuropathy
- •Other protocol-defined Inclusion/Exclusion criteria apply.
研究组 & 干预措施
Arm A
Experimental
干预措施: BMS-986489 (Atigotatug+Nivolumab) (Biological)
Arm A
Experimental
干预措施: Carboplatin (Drug)
Arm B
Active Comparator
干预措施: Atezolizumab (Biological)
Arm A
Experimental
干预措施: Etoposide (Drug)
Arm B
Active Comparator
干预措施: Carboplatin (Drug)
Arm B
Active Comparator
干预措施: Etoposide (Drug)
结局指标
主要结局
Overall Survival (OS)
时间窗: Up to 5 years
次要结局
- Time to definitive deterioration (TTDD)based on the LCSS ASBI defined as the time from randomization until a definitive clinically meaningful decline (≥ 10 point increase from baseline in LCSS ASBI score).(Up to 5 years)
- Number of participants with Adverse Events (AEs)(Up to 135 days after last treatment)
- Number of Participants with Serious Adverse Events (SAEs)(Up to 135 days after last treatment)
- Number of Participants with Adverse Events (AEs) leading to discontinuation and death(Up to 135 days after last treatment)
- Objective Response (OR)(Up to 5 years)
- Duration of Response (DOR)(Up to 5 years)
- Progression Free Survival (PFS)(Up to 5 years)
研究者
研究点 (338)
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