Feasibility of Intratumoral Washing Fluid for Detecting EGFR Mutations in Lung Cancer

Pusan National University Hospital41 enrolled

Overview

The purpose of this study is to evaluate the relevance of intratumoral washing for detection of EGFR mutation (including T790M positivity).

This is a prospective, single-arm, open-label study to assess evaluate the relevance of intratumoral washing by ultrathin bronchoscopy (outer diameter; 3mm) for detection of EGFR mutation (including T790M positivity) using cobas real-time PCR and droplet digital PCR (DDPCR) in patients with NSCLC.

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Non Small Cell Lung Cancer EGFR Gene Mutation

Interventions

Ultarthin bronchoscopy with intratumoral washingDIAGNOSTIC_TEST

Each subject with NSCLC will undergo bronchooscopic procedure. First, ultrathin bronchoscope is inserted and placed within tumor under radial EBUS, virtual bronchoscopic navigation, and fluoroscopy guidance. Then, intratumoral washing is performed. Subsequently, transbronchial lung biopsy is performed under radial EBUS, virtual bronchoscopic navigation, and fluoroscopy guidance.

Eligibility

Sex: ALLMin age: 20 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Age ≥ 20 years * Obtained written informed consent * Patients diagnosed with NSCLC by histology or cytology and inoperable stage IV at the time of study enrollment * Patients with the following EGFR gene mutations: E19Del, L858R alone or concurrent rare EGFR gene mutations (T790M, G719X, exon 20 insertion, S768I) * Patients previously treated with EGFR-TKIs such as gefitinib, erlotinib, afatinib, dacomitinib as first line therapy * Patients who had shown clinical benefits (CR, PR, SD) from EGFR-TKIs and had been confirmed PD on those therapy according to RECIST v 1.1. * Patients who underwent liquid biopsy (plasma) for EGFR mutation at the time of PD on EGFR-TKIs * Patients who plan to undergo tissue biopsy for EGFR mutation at the time of PD on EGFR-TKIs Exclusion Criteria: * Patients who withdraw informed consent * Patients who are unable to undergo liquid biopsy (plasma) and tissue biopsy for EGFR mutation based on the investigator's judgement

Locations (1)

Pusan National University hospital

Busan, South Korea

Outcomes

Primary Outcomes

The DNA and EGFR mutation (including T790M positivity) detection rate in intratumoral washing fluid

Defined as the number of DNA and EGFR mutation (including T790M positivity) detection divided by the total attempts of intratumoral washing by ultrathin bronchoscopy.