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

NCT ID: NCT05517083

Last Updated: 2025-08-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 41 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-04-01
• Study Completion Date: 2024-12-31

Brief Summary

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

Detailed 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.

Conditions

Non Small Cell Lung Cancer; EGFR Gene Mutation

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Ultrathin bronchoscopy with intratumoral washing

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

Group Type: EXPERIMENTAL

Ultarthin bronchoscopy with intratumoral washing

Intervention Type: 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.

Interventions

Ultarthin bronchoscopy with intratumoral washing

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.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Pusan National University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mi-Hyun Kim, PhD

Role: PRINCIPAL_INVESTIGATOR

Pusan National University Hospital

Locations

Pusan National University hospital

Busan, , South Korea

Countries

South Korea

Other Identifiers

2204-006-113

Identifier Type: -

Identifier Source: org_study_id