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

Pusan National University

Status

Completed

Conditions

EGFR Gene Mutation

Non Small Cell Lung Cancer

Treatments

Diagnostic Test: Ultarthin bronchoscopy with intratumoral washing

Study type

Interventional

Funder types

Other

Identifiers

NCT05517083

2204-006-113

Details and patient eligibility

About

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

Full description

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.

Enrollment

41 patients

Sex

All

Ages

20+ years old

Volunteers

No Healthy Volunteers

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