Tarceva With or Without Apatinib in the First-line Therapy of Advanced Lung Adenocarcinoma With Mutant EGFR:a Phase II Study.
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 60
- 主要终点
- Progression free survival
研究概览
简要总结
Tarceva now was established first-line therapy for advanced lung adenocarcinoma with mutant EGFR patients.However,the benefit lasted for about 6-8 months.So we consider to add apatinib,a tyrosine kinase inhibitor of VEGF,to the therapy of these patients.
详细描述
Lung adenocarcinoma is the most common NSCLC,most patient were diagnosed to advanced stage.The first-line therapy include chemotherapy of targeted therapy .Tarceva now was established first-line therapy for advanced lung adenocarcinoma with mutant EGFR patients.However,the benefit lasted for about 6-8 months.So we consider to add apatinib,a tyrosine kinase inhibitor of VEGF,to the therapy of these patients.We designed the study to find out whether the addition of apatinib to the Tarceva would enhance the efficacy of Tarceva.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •lung adenocarcinoma proved by histology;with mutant EGFR;ECOG PS 0-2;Clinical stage IIIb or IV;without other fatal disease;without hemorrhagic disease;normal liver,renal and bone marrow function,not pregnant.
排除标准
- •ECOG PS 3-5;abnormal liver,renal and bone marrow function,pregnant;with severe diseases;wild type EGFR
研究组 & 干预措施
TarceP
Tarceva with Placebo
干预措施: Tarceva (Drug)
TarceP
Tarceva with Placebo
干预措施: Placebo (Drug)
TarceA
Tarceva with Apatinib
干预措施: Apatinib (Drug)
TarceA
Tarceva with Apatinib
干预措施: Tarceva (Drug)
结局指标
主要结局
Progression free survival
时间窗: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months
From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months
次要结局
- Overall survival(From date of randomization until the date of death from any cause, assessed up to 36 months)
- Response rate(through study completion, an average of 1 year)
研究者
Li Rong-qing
Professor
First Affiliated Hospital of Kunming Medical University