T790M Mutation on ctDNA in Patients With NSCLC After EGFR-TKI Failure

First People's Hospital of Hangzhou314 enrolled

Overview

The purpose of this study is to compare the frequency and abundance of T790M mutation among the different Clinical modes of EGFR-TKI failure.

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

Study Type

OBSERVATIONAL

Enrollment

314

Conditions

Non-small Cell Lung Cancer Stage III Non-Small-Cell Lung Cancer Metastatic

Interventions

mutation detectionOTHER

ARMS and ddPCROTHER

ctDNA analysisGENETIC

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 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 Exclusion Criteria: * 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.

Locations (1)

Hangzhou First People's Hospital

Hangzhou, Zhejiang, China

Outcomes

Primary Outcomes

Number of Patients With T790M Mutation Detected by Amplification Refractory Mutation System (ARMS) Assay

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).

Time frame: up to 2 years

Abundance of T790M Mutation Detected by Digital Droplet PCR (ddPCR) Assay in Each Individual Patient

The investigators will describe the abundance of T790M mutation on ctDNA detected by ddPCR assay in patients with NSCLC resistant to TKIs.

Time frame: up to 2 years

Secondary Outcomes

Number of T790M Mutation by ARMS and ddPCR Assays in Each Different Clinical Modes of TKI Failure

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.

Time frame: up to 2 years

Differences of T790M Mutation by ddPCR Among the Different Clinical Modes of TKI Failure

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.

Time frame: up to 2 years

Data from ClinicalTrials.gov

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