Research on the Correlation Between Efficacy of Osimertinib and EGFR T790M Status and Ratio Via Digital Droplet PCR (ddPCR) From Peripheral Blood in NSCLC Patients
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- PFS
研究概览
简要总结
Liquid biopsy is emerging as an essential tool in tumor monitoring and a potential alternative and supplement to tissue biopsy for tumor genotyping, especially in relapsed or metastatic diseases. Liquid biopsy methods for detecting T790M in ctDNA can be qualitative or quantitative, including amplification refractory mutation system PCR (ARMS-PCR), digital droplet polymerase chain reaction (ddPCR), and next generation sequencing (NGS)-based methods. Comparison of multiple detecting platform for EGFR mutations in plasma samples has been undertaken in studies to determine the most feasible assay in clinical practice. In this study, we will investigate the usefulness of ddPCR for quantitative detection of EGFR T790M mutation in peripheral blood, and compared the utility of ddPCR and NGS for guiding decisions regarding osimertinib therapy in NSCLC patients who had develop resistance to first- or second generation EGFR-TKIs.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Factorial
- 主要目的
- Diagnostic
- 盲法
- None
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
- •histologically/cytologically confirmed stage IV NSCLC patients harboring sensitizing EGFR mutations;
- •progression from first or second-generation EGFR-TKI confirmed by radiographic imaging;
- •received both NGS test and ddPCR from peripheral blood simultaneously.
排除标准
- •progression from first- or second-generation EGFR-TKIs as adjuvant therapy;
- •having received third-generation EGFR-TKIs prior to the gene tests;
- •having received NGS test only or ddPCR test only.
研究组 & 干预措施
Osimertinib
Osimertinib 80mg po daily
干预措施: Osimertinib (Drug)
Other treatments
chemotherapy or continuation of TKI monotherapy or in combination of anti-angiogenic agents
干预措施: Osimertinib (Drug)
结局指标
主要结局
PFS
时间窗: up to 1 year
Time from initiation of osimertinib or other anti-tumor treatment to progression or death from any cause
次要结局
- ORR(up to 1 year)
- DCR(up to 1 year)
研究者
Junling Li
Professor
Peking Union Medical College
