Phase II Study of Continuation of Tyrosine Kinase Inhibitor (TKI) With or Without Chemotherapy Beyond Gradual Progression in Advanced Non-small Cell Lung Cancer (NSCLC)
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Progression free survival
研究概览
简要总结
There have been reports suggesting that continuous administration of epidermal growth factor receptor-tyrosine kinase inhibitors (EGFR-TKIs) is advantageous for patients in which gradual disease progression was observed after the establishment of clinical benefit from EGFR-TKIs. However, whether EGFR TKI with or without chemotherapy provides more survival benefit has not been formally evaluated.
详细描述
We design this clinical trial to compare the efficacy of continuation of EGFR TKI with or without chemotherapy in patients beyond gradual progression.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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 75 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
Arm A
TKI alone until rapid progression
干预措施: EGFR tyrosine kinase inhibitor (Drug)
Arm B
TKI combined with investigator's choice of chemotherapy regimen and subsequent line of treatment until rapid progression.
干预措施: EGFR tyrosine kinase inhibitor with chemotherapy (Drug)
结局指标
主要结局
Progression free survival
时间窗: up to 18 months
次要结局
- Objective response rate cacy(up to 18 months)
研究者
Qiong Zhao
Chief of Department of Thoracic Oncology
Zhejiang University