Study of Atezolizumab in Combination With Carboplatin + Paclitaxel +Bevacizumab vs With Pemetrexed + Cisplatin or Carboplatin With Stage IV NON-SQUAMOUS NON-SMALL CELL LUNG CANCER With EGFR(+) or ALK(+)
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 228
- 试验地点
- 1
- 主要终点
- progression-free survival, PFS
研究概览
简要总结
This randomized, Phase III, multicenter, open-label study designed to evaluate the efficacy of Atezolizumab in combination with carboplatin, paclitaxel, bevacizumab compared with treatment with pemetrexed, cisplatin in approximately 228 TKI(tyrosine kinase inhibitor) pre treated patients with Stage IV non squamous non small cell lung cancer with activating EGFR mutation or ALK translocation.
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 —（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
Atezolizumab group
干预措施: Atezolizumab(Tecentriq) (Drug)
Atezolizumab group
干预措施: Bevacizumab (Drug)
Atezolizumab group
干预措施: Carboplatin (Drug)
Atezolizumab group
干预措施: Paclitaxel (Drug)
Control group
干预措施: Pemetrexed (Drug)
Control group
干预措施: Carboplatin or cisplatin (Drug)
结局指标
主要结局
progression-free survival, PFS
时间窗: 34month after the first patient is randomized
To evaluate the efficacy of atezolizumab + carboplatin + paclitaxel + bevacizumab as progression-free survival (PFS) according to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 (RECIST v1.1) in the following treatment:Atezolizumab + carboplatin + paclitaxel + bevacizumab versus Pemetrexed + carboplatin or cisplatin
次要结局
- overall survival(OS)(24month after the last patient is randomized)
- objective response rate(ORR)(24month after the last patient is randomized)
- duration of response(DOR)(24month after the last patient is randomized)
研究者
Myung-Ju Ahn
M.D. Professor Division of Hematology-Oncology Department of Medicine
Samsung Medical Center