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

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

Detailed Description
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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.

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

Conditions
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Non Small Cell Lung Cancer, EGFR Gene Mutation

Intervention / Treatment
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* Diagnostic Test: Ultarthin bronchoscopy with intratumoral washing


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ultrathin bronchoscopy with intratumoral washing<br>Each subject with NSCLC will undergo bronchooscopic procedure for EGFR mutation (including T790M positivity) evaluation. | Diagnostic Test: Ultarthin bronchoscopy with intratumoral washing<br>* 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.<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Carcinoma, Non-Small-Cell Lung, EGFR Genes, Bronchoscopy, Liquid biopsy, T790M