T790M Mutation on ctDNA in Patients With NSCLC After EGFR-TKI Failure
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The purpose of this study is to compare the frequency and abundance of T790M mutation among the different Clinical modes of EGFR-TKI failure.
Condition or disease
Non-small Cell Lung Cancer Stage IIINon-Small-Cell Lung Cancer Metastatic
Other: mutation detectionOther: ARMS and ddPCRGenetic: ctDNA analysis
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
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
Actual Study Start Date :
Actual Primary Completion Date :
Actual Study Completion Date :
Resource links provided by the National Library of Medicine
Number of Patients With T790M Mutation Detected by Amplification Refractory Mutation System (ARMS) Assay [ Time Frame: 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 [ Time Frame: 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.
Secondary Outcome Measures :
Number of T790M Mutation by ARMS and ddPCR Assays in Each Different Clinical Modes of TKI Failure [ Time Frame: up to 2 years ]
The investigators will describe the number of participants with T790M mutation in each different clinical mode of TKI failure by ARMS and ddPCR, and employ chi-square test to analyze the distribution of T790M mutation by ARMS and ddPCR in patients among the different Clinical modes of TKI failure.
Differences of T790M Mutation by ddPCR Among the Different Clinical Modes of TKI Failure [ Time Frame: up to 2 years ]
The investigators will employ Analysis of Variance (ANOVA) method to analyze the differences of T790M mutation by ddPCR in patients among the different Clinical modes of TKI failure.
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Layout table for eligibility information
Ages Eligible for Study:
18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Patients with Non small cell lung cancer (NSCLC) after EGFR-TKI failure
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
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.