An Open Label, Multicenter Study of First-Line Durvalumab Plus Platinum-Based Chemotherapy in Chinese Patients With Extensive Stage Small-Cell Lung Cancer (Oriental)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 166
- 试验地点
- 1
- 主要终点
- Percentage of Participants With Grade ≥3 AEs
研究概览
简要总结
This will be an open-label, single-arm, multicenter, Phase IIIb study to determine the safety of durvalumab + etoposide and cisplatin or carboplatin as first-line treatment in patients with extensive stage small-cell lung cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 130 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
Durvalumab plus 4-6 cycles chemotherapy
Participants will receive treatment with durvalumab + etoposide and either cisplatin or carboplatin (EP) for 4 to 6 cycles. Durvalumab will be administered at a dose of 1500 mg every 3 weeks (Q3W) with first-line chemotherapy (EP) and will continue to be administered as monotherapy every 4 weeks (Q4W) post-chemotherapy until progressive disease (PD). Prophylactic cranial irradiation (PCI) is allowed at the investigators' discretion as per SoC guidance for ES-SCLC. Patients will attend a safety follow up visit 90 days after last dose of durvalumab.
干预措施: Durvalumab plus chemotherapy (Drug)
结局指标
主要结局
Percentage of Participants With Grade ≥3 AEs
时间窗: 19 months
Percentage of Participants With Immune-mediated Adverse Events (imAEs)
时间窗: 19 months
An immune-mediated adverse event (imAE) is defined as an AESI that is associated with drug exposure and is consistent with an immune-mediated mechanism of action and where there is no clear alternate aetiology.
次要结局
- Median Progression Free Survival (PFS)(19 months)
- Proportion of Patients Alive and Progression Free at 12 Months (APF12)(12 months)
- Objective Response Rate (ORR)(19 months)
- Median Overall Survival (OS)(19 months)
- Proportion of Patients Alive at 12 Months (OS12)(12 months)
- Duration of Response (DOR)(19 months)
- Percentage of Participants With AEs(19 months)
- Percentage of Participants With SAEs(19 months)
- Percentage of Participants With Adverse Events of Special Interest (AESI)(19 months)
- Percentage of Participants With AEs Resulting in Treatment Discontinuation(19 months)