Randomized, Open-label, Multicenter Study of Icotinib as Adjuvant Therapy in Treating Stage II-IIIA Non-small-cell Lung Cancer Patients With Positive EGFR Mutation
试验速览
- 阶段
- 2 期
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Recurrence-free Survival
研究概览
简要总结
This study is designed to evaluate the efficacy of icotinib as adjuvant therapy in treating such patients. The primary endpoint is to compare the recurrence-free survival after 1-year or 2-year treatment with icotinib.
详细描述
Adjuvant therapy has been proved effective in treating stage II-IIIA non-small-cell lung cancer. However, few data on the treating time of adjuvant therapy is available. Here we conduct a randomized, prospective study to compare the recurrence-free survival after 1-year or 2-year treatment with icotinib in EGFR-mutated non-small cell lung cancer patients.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The patients signed the written informed consent
- •The patients present with operable stage II-IIIA non-small-cell lung cancers with 19 or 21 exon mutation
- •The patients have no history of anti-cancer therapies including chemotherapy, radiation therapy
- •The patients' Eastern Cooperative Oncology Group scores are ≤ 0-2
排除标准
- •Patients with unresected tumor
- •Wild EGFR type
- •Allergic to the study drug
- •Patients have severe non-cancerous diseases
- •Patients are undergoing current administration of anti-cancer therapies, or are attending some other clinical trials
研究组 & 干预措施
1-year treatment with icotinib
Patients will receive 1-year treatment with icotinib after operation.
干预措施: 1-year treatment with icotinib (Drug)
2-year treatment with icotinib
Patients will receive 2-year treatment with icotinib after operation.
干预措施: 2-year treatment with icotinib (Drug)
结局指标
主要结局
Recurrence-free Survival
时间窗: 6 months
次要结局
- Overall survival(6 months)