A Single Armed Phase ⅡStudy of Alternating Icotinib and Chemotherapy for Advanced Non-small Cell Lung Cancer With EGFR Mutation
试验速览
- 阶段
- 2 期
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Progression Free Survival
研究概览
简要总结
This is a prospective, open, single-center, phase Ⅱ study to assess the efficacy and safety of alternating Icotinib and chemotherapy for advanced non-small cell lung cancer with EGFR mutation.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histological or cytological confirmation of non-small cell lung cancer (NSCLC) in phase ⅢB or phase Ⅳ.
- •Positive EGFR mutation(19 exon or 21 exon)。
排除标准
- •Previous usage of EGFR-TKI or antibody to EGFR: gefitinib, erlotinib, herceptin, erbitux.
- •Severe systemic disease out of control such as unstable or uncompensated respiratory,cardiac,liver,renal diseases.
- •Allergic to icotinib
- •metastases of spinal cord, meninges or meningeal.
研究组 & 干预措施
Icotinib and Pemetrexed/Carboplatin
Icotinib: Icotinib for 18 weeks, 125mg Tid，PO. Chemotherapy: pemetrexed 500mg/m2 iv , 4 cycles. carboplatin AUC=5 iv ,4 cycles.
Then continue with Icotinib, 125mg Tid，PO. until disease progression.
干预措施: Icotinib (Drug)
Icotinib and Pemetrexed/Carboplatin
Icotinib: Icotinib for 18 weeks, 125mg Tid，PO. Chemotherapy: pemetrexed 500mg/m2 iv , 4 cycles. carboplatin AUC=5 iv ,4 cycles.
Then continue with Icotinib, 125mg Tid，PO. until disease progression.
干预措施: Pemetrexed/Carboplatin (Drug)
结局指标
主要结局
Progression Free Survival
时间窗: from the day confirmed NSCLC to the day of first detecting progression, up to 24 months
次要结局
- overall survival time(from the day confirmed NSCLC to the day of death, up to 36 months)
研究者
Qiming Wang
director
Henan Cancer Hospital