Randomized, Open Label, Positive Controlled, Multicenter Trial to Evaluate Icotinib as First-line and Maintenance Treatment in EGFR Mutated Patients With Lung Adenocarcinoma
试验速览
- 阶段
- 4 期
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Progression-free survival
研究概览
简要总结
This study is designed to compare the efficacy and safety of first-line icotinib treatment and first-line chemotherapy followed by maintenance treatment with icotinib.
详细描述
This study is designed to compare the efficacy and safety of first-line icotinib treatment and first-line chemotherapy followed by maintenance with icotinib.
Primary endpoint:
Progression-free survival between first-line icotinib treatment and first-line chemotherapy followed by maintenance with icotinib
Secondary endpoint:
- Overall survival between icotinib and chemotherapy
- Time to Progression between icotinib and chemotherapy
- Objective response rate and disease control rate between icotinib and chemotherapy
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pathologic confirmation of lung adenocarcinoma with measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded on CT); Patients must have previously untreated locally advanced or metastatic NSCLC; Patients must have lung cancer with a documented EGFR activating mutation (exon 19 deletion, L858R).
排除标准
- •Prior chemotherapy Prior treatment with gefitinib, erlotinib, or other drugs that target EGFR Patients must not be receiving any other investigational agents Any evidence of interstitial lung disease
研究组 & 干预措施
Experimental Icotinib
Icotinib: 125mg, oral administration, three times per day.
干预措施: Experimental (Drug)
Chemotherapy Regimen 1
Chemotherapy Regimen 1：Pemetrexe 500 mg/m^2 on Day 1, Cisplatin 75 mg/m^2 on Day 1, 21 days/1 cycle, 2/4 cycles totally, until progression, withdrawal of consent, or unacceptable toxicity.
干预措施: Chemotherapy (Drug)
Chemotherapy Regimen 2
Chemotherapy Regimen 2：Docetaxel 75 mg/m^2 on Day 1, Cisplatin 75 mg/m^2 on Day 1, 21 days/1 cycle, 2/4 cycles totally, until progression, withdrawal of consent, or unacceptable toxicity.
干预措施: Chemotherapy (Drug)
结局指标
主要结局
Progression-free survival
时间窗: 8 months
PFS was defined as the time from the date of first dose of study medication to the date of first documentation of tumor progression or death due to any cause, whichever occurred first.
次要结局
- Objective response rate(3 months)
- Time to Tumor Progression(8 months)
- Overall survival(24 months)
- Number of participants with adverse events(24 months)