High Dose Icotinib in Advanced Non-small Cell Lung Cancer With EGFR 21 Exon Mutation (INCREASE): a Randomized, Open-label Study
试验速览
- 阶段
- 4 期
- 入组人数
- 240
- 试验地点
- 1
- 主要终点
- Progression-free survival
研究概览
简要总结
This randomized, open-label study is aimed to evaluate the efficacy of high-dose icotinib in treating advanced non-small cell lung cancer patients with positive EGFR 21 exon mutation.
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
- •Histologically or cytologically confirmed stage IIIB/IV lung cancer(exclude patients confirmed by sputum cytology)
- •Positive EGFR 21 exon mutation or 19 exon deletion
- •Age 18-75 years old with performance status of 0 to 2
- •With a measurable disease(longest diameters >=10mm with Spiral computed tomography (CT)and >=20mm with conventional CT) according to RECIST Criteria
- •Adequate hematological, biochemical and organ functions.
排除标准
- •Severe systemic disease out of control such as unstable or uncompensated respiratory,cardiac,liver,renal diseases.
- •Evidence of interstitial lung diseases
- •Evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the subject to participate in the study
研究组 & 干预措施
21 icotinib (250mg)
Patients with EGFR 21 exon positive are randomly assigned to higher dose icotinib group to receive icotinib with a dose of 250 mg three times per day, till progressive disease or unaccepted toxicity.
干预措施: icotinib (Drug)
21 icotinib (125mg)
Patients with EGFR 21 exon positive are randomly assigned to routine dose icotinib group to receive icotinib with a dose of 125 mg three times per day, till progressive disease or unaccepted toxicity
干预措施: icotinib (Drug)
19 icotinib (125mg)
Patients with EGFR del 19 exon positive are assigned to routine dose icotinib group to receive icotinib with a dose of 125 mg three times per day, till progressive disease or unaccepted toxicity
干预措施: icotinib (Drug)
结局指标
主要结局
Progression-free survival
时间窗: 12 months
次要结局
- Objective response rates(12 weeks)
- Overall survival(20 months)