Phase II Study to Evaluate the Effectiveness and Safety of Anlotinib Combined With Docetaxel in Progress After First Line Standard Cheomotherapy in Advanced Non-driver Mutation Non- Squamous Non-small Cell Lung Cancer
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 43
- 试验地点
- 1
- 主要终点
- ORR
研究概览
简要总结
The purpose of this study is to evaluate the Effectiveness and Safety of Anlotinib combined with Docetaxel in Progress after First line Standard Cheomotherapy in advanced non-driver mutation non- squamous non-small cell lung cancer
详细描述
The purpose of this study is to evaluate the Effectiveness and Safety of Anlotinib combined with Docetaxel in Progress after First line Standard Cheomotherapy in advanced non-driver mutation non- squamous non-small cell lung cancer .According to the result of TAX317,the ORR of second line standard chemotherapy was 5- 8%. We expect the ORR was 20%. Using PASS11, we calculated the sample size of this study was 39 , according to 10% censoring,the expected sample size is 43.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18，Pathologically proven Non squamous non small cell lung cancer
- •No-drive gene mutaion (EGFR、ALK、ROS1） by NGS
- •Progress after second line
- •PS score 0-2
排除标准
- •Patients received second line treatment
- •Patients received treatment of Anlotinib or Docetaxel
- •Patients with contraindication of chemotherapy
- •Pregnant or breast feeding women
研究组 & 干预措施
Cohorts
Phase II Study to evaluate the Effectiveness and Safety of Anlotinib combined with Docetaxel in Progress after First line Standard Cheomotherapy in advanced non-driver mutation non- squamous non-small cell lung cancer
干预措施: Anlotinib and Docetaxel (Drug)
结局指标
主要结局
ORR
时间窗: may 2018- may 2019 (1 year)
overall response rate
次要结局
- PFS(may 2018- may 2019 (1 year))
- OS(may 2018- may 2019 (1 year))
研究者
Yongchang Zhang
Professor
Hunan Province Tumor Hospital