Phase 3 Study of Erlotinib 100mg or 150mg in Treating EGFR Mutated Patients With Non-small Cell Lung Cancer
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 220
- 试验地点
- 1
- 主要终点
- Progression free survival
研究概览
简要总结
The purpose of this study is to determine whether 100mg erlotinib had similar effect compared with 150mg erlotinib in NSCLC patients with EGFR mutation in China.
详细描述
In China it was confirmed that 150mg Erlotinib was effective in NSCLC patients wtih EGFR mutation, but reducing dose occurring in some patients because of the drug related side-effects. Thus, we sought to investigate that in Chinese patients with EGFR mutation whether low dose (100mg) Erlotinib had similar efficacy but lower toxcities compared with standad dose (150mg) Erlotinib.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histological diagnosis of NSCLC with phase IIIB or IV disease;
- •Sensitive mutation EGFR gene (18, 19 del, 21 L858R gene mutation) (mutation detection methods:ARMS-PCR, sequence method)
- •Never received anti-tumor therapies for the advanced stage;
- •Never used EGFR inhibitors;
- •Measurable disease by RECIST criteria;
- •Male or female patients >=18 years of age;
- •ECOG karnofsky performance 0~3, life expectancy is greater than 12 weeks;
- •Patients must be accessible for treatment and follow-up;
排除标准
- •Previously used EGFR inhibitors
- •Mix ingredients in patients with squamous cell carcinoma, small cell lung cancer;
- •Allergic to erlotinib;
- •Non-measurable lesions
- •Pregnant or lactating women;
- •Patients having other factors that preventing researchers from enrollment them.
研究组 & 干预措施
Erlotinib 100mg
Erlotinib 100mg
干预措施: Erlotinib (Drug)
Erlotinib 150mg
Erlotinib 150mg
干预措施: Erlotinib (Drug)
结局指标
主要结局
Progression free survival
时间窗: 2 years after the initial dose
次要结局
- The objective response rate(Patients will be followed for an expected average of 6 months)
研究者
Jianxing He
The First Affiliated Hospital of Guangzhou Medical Univers
The First Affiliated Hospital of Guangzhou Medical University