2024-515740-23-00招募中3 期
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 Extensive-Stage Small Cell Lung Cancer
Bristol-Myers Squibb Services Unlimited Company68 个研究点 分布在 8 个国家目标入组 212 人开始时间: 2025年3月10日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 212
- 试验地点
- 68
- 主要终点
- Overall survival: how long participants live after entering the study (i.e. after randomization)
研究概览
简要总结
The main goal of this study is to compare whether BMS-986489 FDC, when used with chemotherapy medicines helps people live longer compared with people who take chemotherapy medicines and atezolizumab.
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of ES-SCLC
- •Healthy enough to do their normal activities with little or no help based on the ECOG performance scale.
- •At least one tumour 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
- •People have already received certain types of treatment for extensive stage small cell lung cancer.
- •People have certain health conditions, like spread of small cell lung cancer to the brain and meninges that are causing symptoms, certain lung diseases, heart diseases, infections, autoimmune diseases, other cancers, or a type of nerve damage called peripheral sensory neuropathy.
结局指标
主要结局
Overall survival: how long participants live after entering the study (i.e. after randomization)
Overall survival: how long participants live after entering the study (i.e. after randomization)
次要结局
- Time for disease related symptoms to get worse (TTDD).
- Safety: side effects, the number of side effects, type, severity, seriousness, and outcome.
- Response: measurements to indicate how many patients' tumors shrink or disappear after treatment (Overall Response).
- How long the tumors stay shrunk or disappear (Duration of Response)
- The time during and after treatment that a participant lives without their disease getting worse (Progression Free Survival).
研究者
GSM-CT
Scientific
Bristol-Myers Squibb Services Unlimited Company
研究点 (68)
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