EGFR-TKIs Combine Chemotherapy as First-line Therapy for Patients With Advanced EGFR Mutation-positive NSCLC
试验速览
- 阶段
- 3 期
- 入组人数
- 120
- 主要终点
- Progression-Free Survival (PFS)
研究概览
简要总结
The aim of this study was to compare the efficacy of EGFR-TKIs(Epidermal Growth Factor Receptor-Tyrosine Kinase Inhibitors) treatment plus concurrent chemotherapy versus sequential treatment with EGFR-TKIs and chemotherapy in patients with EGFR(Epidermal Growth Factor Receptor)-mutant non-small-cell lung cancer (NSCLC).
详细描述
This is an open-label, randomized, parallel-group controlled clinical trial, and the study subjects recruited in this study are NSCLC patients mutant for EGFR gene (19del or L858R).
Subjects in the concurrent therapy group were given EGFR-TKIs treatment plus concurrent chemotherapy. Patients in the sequential treatment group were assigned to sequential EGFR-TKIs followed by chemotherapy group, which received TKIs monotherapy and then chemotherapy alone after disease progression; and sequential chemotherapy followed by EGFR-TKIs treatment, which was given first-line chemotherapy for 4 to 6 cycles, followed by maintenance therapy with EGFR-TKIs.
The endpoint of this study included clinical efficacy and safety.
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
- •Stage Ⅳ EGFR mutation-positive NSCLC
- •Initial therapy
- •ECOG performance status 0-1
排除标准
- •EGFR mutation-negative
- •Previous systemic antitumour treatment
研究组 & 干预措施
PC plus erlotinib
pemetrexed 500mg/m2 d1 plus cisplatin 80mg/m2 d1; concurrent erlotinib 150mg/d d1-21, per 3 week, for 4-6cycles, then erlotinib 150mg/d maintain therapy
干预措施: pemetrexed (Drug)
PC plus erlotinib
pemetrexed 500mg/m2 d1 plus cisplatin 80mg/m2 d1; concurrent erlotinib 150mg/d d1-21, per 3 week, for 4-6cycles, then erlotinib 150mg/d maintain therapy
干预措施: cisplatin (Drug)
PC plus erlotinib
pemetrexed 500mg/m2 d1 plus cisplatin 80mg/m2 d1; concurrent erlotinib 150mg/d d1-21, per 3 week, for 4-6cycles, then erlotinib 150mg/d maintain therapy
干预措施: Erlotinib (Drug)
erlotinib
erlotinib 150mg/d until "progress disease"
干预措施: Erlotinib (Drug)
PC
pemetrexed 500mg/m2 d1 plus cisplatin 80mg/m2 d1 for 4-6 cycles
干预措施: pemetrexed (Drug)
PC
pemetrexed 500mg/m2 d1 plus cisplatin 80mg/m2 d1 for 4-6 cycles
干预措施: cisplatin (Drug)
结局指标
主要结局
Progression-Free Survival (PFS)
时间窗: 6 months
次要结局
- Overall Survival (OS)(6 months)
- Adverse Event (AE)(2 months)
- Response Rate (RR)(2 months)