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Completed

NCT Number: NCT02623257

EGFR Mutations on ctDNA in Patients With Advanced NSCLC

The study aims to explore the prevalence of EGFR mutations assessed with ctDNA samples in advanced NSCLC, who had received ≤ 1 prior systemic chemotherapy regimens.

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Key information

Conditions

Non-small Cell Lung Cancer Stage III Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Non-Small-Cell Lung Cancer Metastatic Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hangzhou First People's Hospital

Hangzhou, Zhejiang, 310006, China

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;
  • Patient had received ≤ 1 prior systemic chemotherapy regimens;
  • Provision of blood (plasma) sample for ctDNA testing;
  • Patient must be able to comply with the protocol;

Exclusion criteria

  • Prior received ≥2 systemic chemotherapy regimens;
  • As judged by the investigator, any evidence of severe or uncontrolled systemic disease (e.g. unstable or uncompensated respiratory, cardiac, hepatic or renal disease);
  • 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

Other

ctDNA analysis

Genetic

Primary outcomes

  1. Proportion of patients with EGFR mutation detected by amplification refractory mutation system (ARMS) assay

    Time frame: up to 2 years

    The investigators will describe the proportion of EGFR mutation on ctDNA detected by ARMS assay in patients with non-small cell lung cancer (NSCLC)

Secondary outcomes

  1. Distribution of EGFR mutation by ARMS assays among the different Clinical characteristics

    Time frame: up to 2 years

    The investigators will employ chi-square test to analyze the distribution of EGFR mutation by ARMS in NSCLC patients among the different characteristics including smoking status, gender, age, PS score, and tumor stage

  2. Proportion of treatment-naive patients with EGFR mutation detected by amplification refractory mutation system (ARMS) assay

    Time frame: up to 2 years

    The investigators will describe the proportion of EGFR mutation on ctDNA detected by ARMS assay in treatment-naive patients with non-small cell lung cancer (NSCLC)

  3. Proportion of patients after first-line chemotherapy failure with EGFR mutation detected by amplification refractory mutation system (ARMS) assay

    Time frame: up to 2 years

    The investigators will describe the proportion of EGFR mutation on ctDNA detected by ARMS assay in non-small cell lung cancer (NSCLC) patients after first-line chemotherapy failure

Sponsors and collaborators

Lead sponsor

First People's Hospital of Hangzhou

Other

Registry information

Official study title

A Diagnostic Study to Determine the Prevalence of Epidermal Growth Factor Receptor Mutations Assessed With Circulating Tumor DNA Samples in Advanced Non-small Cell Lung Cancer

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Dec 7, 2015
Registry last updated
Feb 13, 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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