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

Non Small Cell Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05517083
• Other study ID #: 2204-006-113
• Status: Recruiting
• Phase: N/A
• Start date: September 1, 2022
• Est. completion date: June 30, 2024

Study information

• Verified date: October 2023
• Source: Pusan National University Hospital
• Contact: Mi-Hyun Kim, MD, PhD
• Phone: 82 51 240 7889
• Email: mihyunkim[@]pusan.ac.kr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: June 30, 2024
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• EGFR Gene Mutation
• Lung Neoplasms
• Non Small Cell Lung Cancer

Intervention

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.

Locations

Country	Name	City	State
Korea, Republic of	Pusan National University hospital	Busan

Sponsors (1)

Lead Sponsor	Collaborator
Pusan National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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