NCT01776684Unknown不适用
Detection of Resistance Genes From Serially Collected Plasma DNA in Non-small Cell Lung Cancer Patients Harboring EGFR Activating Mutation Who Are Being Treated With EGFR TKIs
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- detection of resistant gene
研究概览
简要总结
To detect resistance gene from serially collected plasma DNA in non-small cell lung cancer harbouring EGFR activating mutation who are being treated with EGFR TKIs by using castPCR method.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 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
- •Histologically confirmed NSCLC
- •Aged of or older than 20 years
- •ECOG performance status 0-2
- •Adequate hematological, renal, hepatic function
- •Patients with tumors harboring EGFR mutation (del 19 or L858R mutation)
- •Patient who are about to be treated with EGFR TKI (gefitinib, erlotinib or other EGFR TKI)
- •At least more than one measurable disease
- •Informed consent
排除标准
- •Active infection
- •Active bleeding
研究组 & 干预措施
EGFR positive arm
Experimental
Patients with NSCLC harboring activating EGFR mutation (deletion in exon 19, L858R mutation in exon 21)
干预措施: EGFR TKIs (gefitinib, erlotinib, afatinib, et al) (Drug)
结局指标
主要结局
detection of resistant gene
时间窗: 24 months
To evaluate the efficiency of castPCR method for detection of resistance genes, especially, T790M mutation from serially collected plasma DNA in non-small cell lung cancer patients harboring EGFR activating mutation who are being treated with EGFR TKIs
次要结局
未报告次要终点
研究者
Myung-Ju Ahn
M.D., Professor
Samsung Medical Center
研究点 (1)
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