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

NCT05517083 | Completed

• 1 other identifier: 2204-006-113
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Non Small Cell Lung Cancer; EGFR Gene Mutation

Keywords

Carcinoma, Non-Small-Cell Lung; EGFR Genes; Bronchoscopy; Liquid biopsy; T790M

Outcome Measures

Primary Outcomes (1)

• 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.

  through study completion, an average of 1 year

Secondary Outcomes (5)

• The concordance rate of EGFR mutation (including T790M positivity) detection rate among intratumoral washing fluid, plasma, and tissue

  through study completion, an average of 1 year

• The EGFR mutation (including T790M positivity) sensitivity and specificity in intratumoral washing fluid

  through study completion, an average of 1 year

• Objective response rate

  through study completion, an average of 1 year

• Disease control rate

  through study completion, an average of 1 year

• Progression-free survival

  through study completion, an average of 1 year

Study Arms (1)

Ultrathin bronchoscopy with intratumoral washing

EXPERIMENTAL

Each subject with NSCLC will undergo bronchooscopic procedure for EGFR mutation (including T790M positivity) evaluation.

Diagnostic Test: Ultarthin bronchoscopy with intratumoral washing

Interventions

Ultarthin bronchoscopy with intratumoral washing DIAGNOSTIC_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.

Ultrathin bronchoscopy with intratumoral washing

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Pusan National University Hospital: lead

Study Sites (1)

Pusan National University hospital

Busan, South Korea

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Mi-Hyun Kim, PhD

  Pusan National University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 30, 2022
• First Posted: August 26, 2022
• Study Start: April 1, 2022
• Primary Completion: September 30, 2023
• Study Completion: December 31, 2024
• Last Updated: August 20, 2025

Record last verified: 2025-08

Locations

KR (1)