Frequency and Abundance of T790M Mutation on Circulating Tumor DNA in Patients With Non-small Cell Lung Cancer After Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitors Treatment Failure: a Perspective Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 314
- 试验地点
- 1
- 主要终点
- Number of Patients With T790M Mutation Detected by Amplification Refractory Mutation System (ARMS) Assay
研究概览
简要总结
The purpose of this study is to compare the frequency and abundance of T790M mutation among the different Clinical modes of EGFR-TKI failure.
详细描述
An observational, non-interventional, multi-central study of comparison of the frequency and abundance of T790M mutation using both amplification refractory mutation system (ARMS) and digital droplet PCR (ddPCR) methods among the different Clinical modes of non-small cell lung cancer (NSCLC) patients with epidermal growth factor receptor tyrosine kinase inhibitor (EGFR-TKI) failure
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
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
- •Histologically confirmed stage IIIB/IV NSCLC.
- •Investigator confirmed progression according RECIST 1.1 during EGFR-TKI treatment within 28 days of the enrollment
- •Activating mutation (G719A/C/S; Exon 19 insertion/deletion; L858R; L861Q) in the EGFR gene or have had at least partial response with EGFR TKI lasting ≥ 6 months
- •Patient must be able to comply with the protocol
排除标准
- •Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 defined disease progression for more than 28 days while on previous EGFR-TKI treatment.
- •Patient has been treated with any investigational agent for any indication within 4 weeks of study treatment.
- •Histologically confirmed small cell lung cancer or other metastatic tumors
- •Patient with no histologic or cytological diagnosis.
结局指标
主要结局
Number of Patients With T790M Mutation Detected by Amplification Refractory Mutation System (ARMS) Assay
时间窗: up to 2 years
The investigators will describe the number of T790M mutation on ctDNA detected by ARMS assay in patients with non-small cell lung cancer (NSCLC) resistant to tyrosine kinase inhibitors (TKIs).
Abundance of T790M Mutation Detected by Digital Droplet PCR (ddPCR) Assay in Each Individual Patient
时间窗: up to 2 years
The investigators will describe the abundance of T790M mutation on ctDNA detected by ddPCR assay in patients with NSCLC resistant to TKIs.
次要结局
- Number of T790M Mutation by ARMS and ddPCR Assays in Each Different Clinical Modes of TKI Failure(up to 2 years)
- Differences of T790M Mutation by ddPCR Among the Different Clinical Modes of TKI Failure(up to 2 years)