Icotinib as Adjuvant Therapy Compared With Standard Chemotherapy in Stage II-IIIA Non-small Cell Lung Cancer With EGFR-mutation: a Randomized, Positive-controlled, Phase 3 Study (EVIDENCE, CCTC-1501)
试验速览
- 阶段
- 3 期
- 入组人数
- 320
- 试验地点
- 8
- 主要终点
- disease free survival
研究概览
简要总结
Adjuvant therapy has been proved effective in treating earlier stage or less advanced non-small-cell lung cancer. This study is designed to evaluate the efficacy of icotinib as adjuvant therapy in treating stage II-IIIA non-small cell lung cancer patients with EGFR mutation. The primary endpoint is disease-free survival.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pathologically confirmed non-small cell lung cancer after surgical resection
- •Stage II-IIIA disease according to 7th edition of TNM staging
- •Positive EGFR gene mutation (19/21)
- •At least 1-year life expectancy
- •Adequate organ function
排除标准
- •Previous systemic anti-tumor therapy, including chemotherapy or targeted therapy(Including but not limited to monoclonal antibodies, small molecule tyrosine kinase inhibitor, etc
- •Other co-existing malignancies or malignancies diagnosed within the last 5 years with the exception of basal cell carcinoma or cervical cancer in situ
- •Pneumonectomy of right lung
- •Any unresolved chronic toxicity from previous anticancer therapy
- •Allergic to study drug
研究组 & 干预措施
icotinib
125 mg three times daily (375 mg per day) orally for two years.
干预措施: Icotinib (Drug)
standard chemotherapy
Vinorelbine 25 mg/m^2, intravenously guttae, day 1 and day 8, 21 days/cycle, 4 cycles.
cisplatin 75 mg/m^2, intravenously guttae, day 1, 21 days/cycle, 4 cycles.
For adenocarcinoma: pemetrexed (500 mg/m^2, day 1)/cisplatin (75 mg/m^2, day 1) for 4 cycles.
干预措施: Chemotherapy (Drug)
结局指标
主要结局
disease free survival
时间窗: 48 months
the time from the date of randomization to the first observation of tumor recurrence, metastasis (based on imaging ) or death
次要结局
- overall survival(60 months)