Clinical trial NCT05517083: Feasibility of Intratumoral Washing Fluid for Detecting EGFR Mutations in Lung Cancer
Official title: Feasibility of Intratumoral Washing Fluid for Detecting EGFR Mutations in Advanced Non-small Cell Lung Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Non Small Cell Lung Cancer
EGFR Gene Mutation
Keywords: Carcinoma, Non-Small-Cell Lung
EGFR Genes
Bronchoscopy
Liquid biopsy
T790M
Lead sponsor: Pusan National University Hospital
Sponsor class: OTHER
First posted: 2022-08-26
Enrollment: 70
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

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

Primary outcomes:
measure: The DNA and EGFR mutation (including T790M positivity) detection rate in intratumoral washing fluid
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
measure: The concordance rate of EGFR mutation (including T790M positivity) detection rate among intratumoral washing fluid, plasma, and tissue
timeFrame: through study completion, an average of 1 year
measure: The EGFR mutation (including T790M positivity) sensitivity and specificity in intratumoral washing fluid
timeFrame: through study completion, an average of 1 year
measure: Objective response rate
timeFrame: through study completion, an average of 1 year
measure: Disease control rate
timeFrame: through study completion, an average of 1 year
measure: Progression-free survival
timeFrame: through study completion, an average of 1 year
Other outcomes:
Locations:
city: Busan
country: Korea, Republic of
facility: Pusan National University hospital
Study officials:
affiliation: Pusan National University Hospital
name: Mi-Hyun Kim, PhD
role: PRINCIPAL_INVESTIGATOR
References: