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Completed

NCT Number: NCT02418234

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

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hangzhou First People's Hospital

Hangzhou, Zhejiang, 310006, China

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

mutation detection

Other

ARMS and ddPCR

Other

ctDNA analysis

Genetic

Primary outcomes

  1. 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).

  2. 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 outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

First People's Hospital of Hangzhou

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2016
Study completion
2017
First posted
Apr 16, 2015
Registry last updated
Mar 12, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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