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

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

NCT ID: NCT05517083

Condition: Non Small Cell Lung Cancer
EGFR Gene Mutation

Conditions: Official terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung

Conditions: Keywords:
Carcinoma, Non-Small-Cell Lung
EGFR Genes
Bronchoscopy
Liquid biopsy
T790M

Study type: Interventional

Study phase: N/A

Overall status: Recruiting

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

Primary purpose: Diagnostic

Masking: None (Open Label)

Intervention:

Intervention type: Diagnostic Test
Intervention name: Ultarthin bronchoscopy with intratumoral washing
Description: 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.
Arm group label: Ultrathin bronchoscopy with intratumoral washing

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.

Criteria for 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

Gender: All

Minimum age: 20 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Pusan National University hospital

Address:
City: Busan
Country: Korea, Republic of

Status: Recruiting

Contact:
Last name: Mi-Hyun Kim, MD, PhD

Phone: 82 51 240 7889
Email: mihyunkim@pusan.ac.kr

Contact backup:
Last name: Soo Han Kim, MD, PhD

Phone: 82 51 240 7889
Email: kshyjt1004@gmail.com

Start date: September 1, 2022

Completion date: December 31, 2024

Lead sponsor:
Agency: Pusan National University Hospital
Agency class: Other

Source: Pusan National University Hospital

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05517083