the Effectiveness and Safety Study on Apatinib Combined With Vinorelbine Used for Driver Gene Mutation Negative Third-line and Third-line Post Progression Advanced Non-small Cell Lung Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 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 assess the safety and effectiveness of Apatinib Combined With Vinorelbine Used for Driver Gene Mutation Negative Third-line and Third-line Posterior Advanced Non-small Cell Lung Cancer
详细描述
This efficacy and safety research plan to explore the use of Apatinib combined with Vinorelbine to driven gene mutation negative three line and three line later non-small cell lung cancer.According to the result of TAX317,the investigators expect the effective rate is 20% and 80% of degree of assurance.Single arm bilateral experiment's sample size is calculated 27, according to 10% censoring,the expected sample size is 30.
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 small cell lung cancer
- •Adenocarcinoma，No-drive gene mutaion (EGFR、ALK、ROS1） by NGS
- •Squamous cell carcinoma，no gene detection
- •Progress after second line
- •PS score >2
排除标准
- •Patients received apatinib or Vinorelbine treatment before
- •EGFR, ALK or ROS1 mutation
- •Patients with contraindication of chemotherapy
- •Pregnant or breast feeding women
研究组 & 干预措施
Apatinib Combined With Vinorelbine
Apatinib Combined With Vinorelbine Used for Driver Gene Mutation Negative Third-line and Third-line Post Progression Advanced Non-small Cell Lung Cancer
干预措施: Apatinib Combined With Vinorelbine (Drug)
结局指标
主要结局
ORR
时间窗: Approximately 1 years
To measure the patients's overall response rate
次要结局
- PFS(Approximately 1 years)
- OS(Approximately 1 years)
研究者
Yongchang Zhang
Professor
Hunan Province Tumor Hospital