Intercalated Combination of Chemotherapy Plus Icotinib for Patients Undergoing Resection of EGRF Mutation-positive Non-small-cell Lung Cancer
试验速览
- 阶段
- 2 期
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Disease free survival
研究概览
简要总结
Non-small-cell lung cancer (NSCLC) patients with activating epidermal growth factor receptor (EGFR) mutations are exquisitely sensitive to epidermal growth factor receptor tyrosine kinase inhibitors (EGFR-TKIs) which is widely used in advanced patients. Whether treatment with EGFR-TKIs improves outcomes in patients with resected NSCLC harboring EGFR mutations is still under investigated. This study aims to observe and compare the efficacy and safety of intercalated combination of chemotherapy plus icotinib in patients undergoing resection of EGRF mutation-positive non-small cell lung cancer stagingⅠB (with high risk factor) to ⅢA.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients undergoing completely resection of EGRF mutation-positive NSCLC
- •Staging ⅠB (with high risk factor) to ⅢA
- •Adequate hematological, biochemical and organ functions.
排除标准
- •Systemic anticancer therapy prior to surgery, other malignancies before or during the study, any unstable illness, women who were pregnant or lactating.
研究组 & 干预措施
intercalated treatment
Patients will receive 4 cycles treatment: chemotherapy(day 1) plus intercalated icotinib(day 8-21) every 3 weeks, and then oral icotinib continuously for 2 years or until disease progression or unacceptable toxic effects
干预措施: icotinib (Drug)
结局指标
主要结局
Disease free survival
时间窗: from the date of surgery until the date of first confirmed disease relapse or metastasis, assessed up to 5 years
次要结局
- Number of Participants with Adverse Effects(duration of receiving chemotherapy and oral icotinib, expected to be 2.5 years)
研究者
Kaican Cai
Chief Physician，Associate Professor
Nanfang Hospital, Southern Medical University