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临床试验/NCT05458726
NCT05458726Unknown2 期

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

Peking Union Medical College1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2020年9月15日最近更新:
适应症
干预措施
相关药物

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

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

Experimental

Osimertinib 80mg po daily

干预措施: Osimertinib (Drug)

Other treatments

Sham Comparator

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

发起方
Peking Union Medical College
申办方类型
Other
责任方
Principal Investigator
主要研究者

Junling Li

Professor

Peking Union Medical College

研究点 (1)

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