Phase III Study of Osimertinib or Docetaxel-bevacizumab as Third-line Treatment in EGFR T790M Mutated Non-Small Cell Lung Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 147
- 试验地点
- 1
- 主要终点
- progression free survival
研究概览
简要总结
Acquired epidermal growth factor receptor (EGFR) T790M mutation is the most common genetic change after resistant to first generation EGFR tyrosine kinase inhibitor (EGFR TKI) in non-small cell lung cancer. After a 10 to 14 months median progression-free survival with the treatment of first generation EGFR TKI, half of patients will get disease progression.For patients progression after treated with first line EGFR TKI and second line double bullets chemotherapy or chemotherapy then EGFR TKI, optimal third line therapy is quite critical important for benefit patients' survival. We conducted this study was aimed to compare the efficacy and toxicity between osimertinib and docetaxel-bevacizumab as the third line therapy in patients with local advanced or metastatic non-squamous cell lung cancer.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •local advanced or metastatic non-small cell lung cancer
- •large cell lung carcinoma or adenocinoma
- •Previously treated by TKI-Chemotherapy or Chemotherapy-TKI
- •EGFR T790M positive
- •No uncontrolled hypertension
- •No active bleeding or thrombosis in recent 6 months
- •No previously treated with VEGF antibody
排除标准
- •newly diagnosed thrombosis
- •anti-coagulation therapy
- •uncontrolled hypertension
- •uncontrolled nephropathy
研究组 & 干预措施
Docetaxel, bevacizumab
docetaxel, 75mg/m2, intravenous infusion on day 1. VEGF monoclonal antibody bevacizumab, 7.5 mg/m2, intravenous infusion on day 1, every 21days a cycle，until disease progression, intolerable toxicities, or patient death.
干预措施: docetaxel, bevacizumab (Drug)
EGFR TKI
osimertinib 80mg oral once daily，until disease progression, intolerable toxicities, or patient death.
干预措施: Osimertinib (Drug)
结局指标
主要结局
progression free survival
时间窗: Average 10 months
次要结局
未报告次要终点
研究者
Youxin Ji
Director
Qingdao Central Hospital