Feasibility of Intratumoral Washing Fluid for Detecting EGFR Mutations in Advanced Non-small Cell Lung Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 41
- 试验地点
- 2
- 主要终点
- The DNA and EGFR mutation (including T790M positivity) detection rate in intratumoral washing fluid
研究概览
简要总结
The purpose of this study is to evaluate the relevance of intratumoral washing for detection of EGFR mutation (including T790M positivity).
详细描述
This is a prospective, single-arm, open-label study to assess evaluate the relevance of intratumoral washing by ultrathin bronchoscopy (outer diameter; 3mm) for detection of EGFR mutation (including T790M positivity) using cobas real-time PCR and droplet digital PCR (DDPCR) in patients with NSCLC.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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
- •Age ≥ 20 years
- •Obtained written informed consent
- •Patients diagnosed with NSCLC by histology or cytology and inoperable stage IV at the time of study enrollment
- •Patients with the following EGFR gene mutations: E19Del, L858R alone or concurrent rare EGFR gene mutations (T790M, G719X, exon 20 insertion, S768I)
- •Patients previously treated with EGFR-TKIs such as gefitinib, erlotinib, afatinib, dacomitinib as first line therapy
- •Patients who had shown clinical benefits (CR, PR, SD) from EGFR-TKIs and had been confirmed PD on those therapy according to RECIST v 1.
- •Patients who underwent liquid biopsy (plasma) for EGFR mutation at the time of PD on EGFR-TKIs
- •Patients who plan to undergo tissue biopsy for EGFR mutation at the time of PD on EGFR-TKIs
排除标准
- •Patients who withdraw informed consent
- •Patients who are unable to undergo liquid biopsy (plasma) and tissue biopsy for EGFR mutation based on the investigator's judgement
结局指标
主要结局
The DNA and EGFR mutation (including T790M positivity) detection rate in intratumoral washing fluid
时间窗: through study completion, an average of 1 year
Defined as the number of DNA and EGFR mutation (including T790M positivity) detection divided by the total attempts of intratumoral washing by ultrathin bronchoscopy.
次要结局
- The concordance rate of EGFR mutation (including T790M positivity) detection rate among intratumoral washing fluid, plasma, and tissue(through study completion, an average of 1 year)
- The EGFR mutation (including T790M positivity) sensitivity and specificity in intratumoral washing fluid(through study completion, an average of 1 year)
- Objective response rate(through study completion, an average of 1 year)
- Progression-free survival(through study completion, an average of 1 year)
- Disease control rate(through study completion, an average of 1 year)