NCT06211036进行中（未招募）3 期
A Phase 3, Open-label, Multicenter, Randomized Study of Tarlatamab in Combination With Durvalumab vs Durvalumab Alone in Subjects With Extensive-Stage Small-Cell Lung Cancer Following Platinum, Etoposide and Durvalumab (DeLLphi-305)
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 发起方
- Amgen
- 入组人数
- 563
- 试验地点
- 218
- 主要终点
- OS
研究概览
简要总结
The primary objective of this study is to compare the efficacy of tarlatamab plus durvalumab with durvalumab alone on prolonging overall survival (OS).
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
- None
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Tarlatamab in Combination With Durvalumab
Experimental
Participants will receive tarlatamab once every 2 weeks (Q2W) and durvalumab once every 4 weeks (Q4W).
干预措施: Tarlatamab (Drug)
Tarlatamab in Combination With Durvalumab
Experimental
Participants will receive tarlatamab once every 2 weeks (Q2W) and durvalumab once every 4 weeks (Q4W).
干预措施: Durvalumab (Drug)
Durvalumab Alone
Active Comparator
Participants will receive durvalumab Q4W alone.
干预措施: Durvalumab (Drug)
结局指标
主要结局
OS
时间窗: Up to approximately 3 years
次要结局
- PFS at 6 Months(6 months)
- PFS at 1 Year(1 year)
- PFS at 2 Years(2 years)
- OS at 6 Months(6 months)
- OS at 1 Year(1 year)
- OS at 2 Years(2 years)
- OS at 3 Years(3 years)
- Time to Progression (TTP)(Up to approximately 3 years)
- Duration of Response (DoR)(Up to approximately 3 years)
- Progression Free Survival (PFS)(Up to approximately 3 years)
- Overall Response (OR)(Up to approximately 3 years)
- Disease Control (DC) Rate(Up to approximately 3 years)
- Number of Participants with Treatment-emergent Adverse Events (TEAEs)(Up to approximately 9 months)
- Number of Participants with TEAEs Grade 3 or Above per Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0.(Up to approximately 3 years)
- Number of Participants with Serious TEAEs(Up to approximately 3 years)
- Number of Participants with TEAEs Leading to Discontinuation of Treatment(Up to approximately 3 years)
- Number of Participants with Fatal TEAEs(Up to approximately 3 years)
- Number of Participants with Treatment-related Adverse Events (AEs)(Up to approximately 9 months)
- Number of Participants with Adverse Events of Interest (EOI)(Up to approximately 9 months)
- Serum Concentrations of Tarlatamab(Day 1 up to approximately 6 months)
- Number of Participants with Antitarlatamab Antibody Formation(Up to approximately 9 months)
- Time to First Deterioration (TTD) for Physical Function as Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30 (EORTC-QLQ-C30)(Baseline to Week 13 and Week 25)
- Change in Disease Symptoms of Cough as Measured Using EORTC-QLQ LC13(Baseline to Week 13 and Week 25)
- Change in Disease Symptoms of Chest Pain as Measured Using EORTC-QLQ LC13(Baseline to Week 13 and Week 25)
- Change in Disease Symptoms of Dyspnea as Measured Using EORTC-QLQ LC13(Baseline to Week 13 and Week 25)
- TTD for Global Health Status as Measured by EORTC-QLQ-C30(Baseline to Week 13 and Week 25)
- TTD for Quality of Life as Measured by EORTC-QLQ-C30(Baseline to Week 13 and Week 25)
研究者
研究点 (218)
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相关资讯
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