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

Feasibility of Intratumoral Washing Fluid for Detecting EGFR Mutations in Advanced Non-small Cell Lung Cancer

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

Study Overview

• Status: Recruiting
• Conditions: Non Small Cell Lung Cancer; EGFR Gene Mutation
• Intervention / Treatment: Diagnostic test: Ultarthin bronchoscopy with intratumoral washing

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.

• Study Type: Interventional
• Enrollment (Estimated): 70
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mi-Hyun Kim, MD, PhD; Phone Number: 82 51 240 7889; Email: mihyunkim@pusan.ac.kr
• Study Contact Backup: Name: Soo Han Kim, MD, PhD; Phone Number: 82-51-240-7889; Email: kshyjt1004@gmail.com

Study Locations

• Korea, Republic of
  • Busan, Korea, Republic of
    • Recruiting
    • Pusan National University Hospital
    • Contact: Mi-Hyun Kim, MD, PhD; Phone Number: 82 51 240 7889; Email: mihyunkim@pusan.ac.kr
    • Contact: Soo Han Kim, MD, PhD; Phone Number: 82 51 240 7889; Email: kshyjt1004@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Ultrathin bronchoscopy with intratumoral washing; Each subject with NSCLC will undergo bronchooscopic procedure for EGFR mutation (including T790M positivity) evaluation.

Diagnostic test: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
The concordance rate of EGFR mutation (including T790M positivity) detection rate among intratumoral washing fluid, plasma, and tissue	The concordance rate of EGFR mutation (including T790M positivity) detection rate in intratumoral washing fluid, compared with plasma and tissue (gold standard).	through study completion, an average of 1 year
The EGFR mutation (including T790M positivity) sensitivity and specificity in intratumoral washing fluid	The sensitivity and specificity of EGFR mutation (including T790M positivity) in intratumoral washing fluid compared with tissue (gold standard).	through study completion, an average of 1 year
Objective response rate	Objective response rate (ORR) including rate of complete response (CR) and partial response (PR) based on RECIST 1.1.	through study completion, an average of 1 year
Disease control rate	Disease control rate (DCR) including rate of CR, PR and stable disease (SD) based on RECIST 1.1.	through study completion, an average of 1 year
Progression-free survival	Progression-free survival (PFS) the time from first dose of the study drug until the date of progressive disease (PD) based on RECIST 1.1 or death by any cause.	through study completion, an average of 1 year

Collaborators and Investigators

• Sponsor: Pusan National University Hospital
• Investigators: Principal Investigator: Mi-Hyun Kim, PhD, Pusan National University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2022
• Primary Completion (Estimated): December 31, 2023
• Study Completion (Estimated): June 30, 2024

Study Registration Dates

• First Submitted: July 30, 2022
• First Submitted That Met QC Criteria: August 25, 2022
• First Posted (Actual): August 26, 2022

Study Record Updates

• Last Update Posted (Actual): October 17, 2023
• Last Update Submitted That Met QC Criteria: October 16, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: Bronchoscopy; Carcinoma, Non-Small-Cell Lung; Liquid biopsy; T790M; EGFR Genes
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
• Other Study ID Numbers: 2204-006-113

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No