Icotinib as Maintenance Treatment After Chemotherapy 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
- 50
- 主要终点
- Disease free survival
研究概览
简要总结
Epidermal growth factor receptor (EGFR) mutations occur in up to 50% of Asian patients with non-small cell lung cancer (NSCLC). Treatment of advanced NSCLC patients with EGFR-tyrosine kinase inhibitors (EGFR-TKI) confers a significant survival benefit. This study assessed the efficacy and safety of chemotherapy with or without icotinib in patients undergoing resection of stage IB to IIIA EGFR-mutated NSCLC.
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 —（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
- •PS = 0 or 1
- •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
Chemotherapy & Icotinib
patients received four cycles of platinum-based doublet chemotherapy (150 mg/m2 paclitaxel plus 80 mg/m2 nedaplatin or 30mg/m2 lobaplatin on day one of a three-week cycle).Two weeks after chemotherapy completed, patients assigned to the consolidation therapy group began oral icotinib treatment (125 mg, thrice daily). Icotinib treatment continued for four to eight months, or until the occurrence of disease relapse, metastasis or unacceptable icotinib or chemotherapy toxicity.
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)