Feasibility of Intratumoral Washing Fluid for Detecting EGFR Mutations in Lung Cancer
- Conditions
- Non Small Cell Lung CancerEGFR Gene Mutation
- Interventions
- Diagnostic Test: Ultarthin bronchoscopy with intratumoral washing
- Registration Number
- NCT05517083
- Lead Sponsor
- Pusan National University Hospital
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 70
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Ultrathin bronchoscopy with intratumoral washing Ultarthin bronchoscopy with intratumoral washing Each subject with NSCLC will undergo bronchooscopic procedure for EGFR mutation (including T790M positivity) evaluation.
- Primary Outcome Measures
Name Time Method The DNA and EGFR mutation (including T790M positivity) detection rate in intratumoral washing fluid through study completion, an average of 1 year Defined as the number of DNA and EGFR mutation (including T790M positivity) detection divided by the total attempts of intratumoral washing by ultrathin bronchoscopy.
- Secondary Outcome Measures
Name Time Method The concordance rate of EGFR mutation (including T790M positivity) detection rate among intratumoral washing fluid, plasma, and tissue through study completion, an average of 1 year The concordance rate of EGFR mutation (including T790M positivity) detection rate in intratumoral washing fluid, compared with plasma and tissue (gold standard).
The EGFR mutation (including T790M positivity) sensitivity and specificity in intratumoral washing fluid through study completion, an average of 1 year The sensitivity and specificity of EGFR mutation (including T790M positivity) in intratumoral washing fluid compared with tissue (gold standard).
Objective response rate through study completion, an average of 1 year Objective response rate (ORR) including rate of complete response (CR) and partial response (PR) based on RECIST 1.1.
Progression-free survival through study completion, an average of 1 year 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.
Disease control rate through study completion, an average of 1 year Disease control rate (DCR) including rate of CR, PR and stable disease (SD) based on RECIST 1.1.
Trial Locations
- Locations (1)
Pusan National University hospital
🇰🇷Busan, Korea, Republic of