Which Treatment Strategy is Best in Non-small Cell Lung Cancer Patients Harboring EGFR Mutant Type After First/Second Line EGFR-TKI Failure, a Retrospective Study
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 800
- 试验地点
- 1
- 主要终点
- Progression Free Survival 2 (PFS2)
研究概览
简要总结
This is a multi-center retrospective study, designing to access the best treatment strategy in non-small cell lung cancer (NSCLC) patients harboring EGFR mutant type after first/second line EGFR-TKI failure. The study end point is Progression Free Survival 2 (PFS2), which is defined as the time period from Progression Disease 1(PD1) to Progression Disease 2(PD2). PD1 is defined as the first tumor progression time from taking EGFR-TKI evaluated by Recist 1.1 criterion, and PD2 as the second tumor progression time after EGFR-TKI failure no matter what second/third line treatment was, PD2 is also evaluated by Recist 1.1 criterion.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Retrospective
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
- •Patients who was confirmed stage IV (according to International Association for the Study of Lung Cancer（IASLC） TNM staging, 2009) non-small cell lung cancer (NSCLC) by histology or cytology between year 2009 to 2013, harboring EGFR mutant type (19 and/or 21 exon mutation).
- •Appraisable disease, that is there must be at least one lesion with the longest diameter>10mm according to Recist 1.1 criterion (by contrast CT).
- •Patients who take EGFR-TKI as first/second line therapy.
排除标准
- •Patients who has taken EGFR-TKI before.
- •Patients who take EGFR-TKI as third or more line.
- •Patients who take EGFR-TKI concurrent with chemotherapy or other anti-tumor drug.
- •The evaluated lesions has treated with radiotherapy before or concurrent with EGFR-TKI.
- •Patients whose EGFR expression is positive by immunochemical and/or EGFR amplification is positive by Fluorescence In Situ Hybridization(FISH), without mutation detection evidence.
结局指标
主要结局
Progression Free Survival 2 (PFS2)
时间窗: 6 months
次要结局
- overall survival (OS)(3 year)
研究者
Li-kun Chen
Associate Professor/Associate chief physician
Sun Yat-sen University