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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
80
Osimertinib or chemotherapy
Junling Li
Beijing, Beijing Municipality, China
RECRUITINGPFS
Time from initiation of osimertinib or other anti-tumor treatment to progression or death from any cause
Time frame: up to 1 year
ORR
the sum of CR and PR rates
Time frame: up to 1 year
DCR
the sum of CR ,PR and SD rates
Time frame: up to 1 year
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