NCT03381066Unknown3 期
A Phase III, Randomized, Multi-center Study to Determine the Efficacy of the Intercalating Combination Treatment of Chemotherapy and Gefitinib or Chemotherapy as Adjuvant Treatment in NSCLC With Common EGFR Mutations.
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 入组人数
- 225
- 试验地点
- 1
- 主要终点
- disease-free survival
研究概览
简要总结
This study aims to compare the efficacy of intercalating chemotherapy (gefitinib and pemetrexed/cisplatin) and chemotherapy (navelbine/cisplatin) in completely resected NSCLC with common EGFR mutations.
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
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Completely resected non-squamous cell NSCLC with stage IIa to IIIb (excluding N3) according to Version 8 of the IASLC Staging Manual in Thoracic Oncology
- •Tumors with common EGFR mutations (19del or L858R)
- •Adequate oran function
排除标准
- •Patients who were exposed to the chemotherapy or EGFR TKIs for NSCLC.
- •Patients with interstitial lung disease
研究组 & 干预措施
Intercalating arm
Experimental
gefitinib, pemetrexed,cisplatin
干预措施: gefitinib, pemetrexed,cisplatin (Drug)
chemotherapy alone arm
Active Comparator
Vinorelbine, cisplatin
干预措施: Vinorelbine, cisplatin (Drug)
结局指标
主要结局
disease-free survival
时间窗: 5 years
Time from the randomization to recurrence or any cause of death.
次要结局
- Overall survival(5 year)
- Number of participants with treatment-related adverse events as assessed by CTCAE4.0(5 years)
研究者
研究点 (1)
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