Non Small Cell Lung CancerNCT05517083
Feasibility of Intratumoral Washing Fluid for Detecting EGFR Mutations in Lung Cancer
A study testing Ultarthin bronchoscopy with intratumoral washing in people with Non Small Cell Lung Cancer and EGFR Gene Mutation, run by Pusan National University Hospital at 1 site in South Korea.
Trial summary
The purpose of this study is to evaluate the relevance of intratumoral washing for detection of EGFR mutation (including T790M positivity). Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Non Small Cell Lung Cancer, EGFR Gene Mutation
- What is being tested?
- Ultarthin bronchoscopy with intratumoral washing
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Apr 2022to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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).
Read the 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.
- Conditions
- Non Small Cell Lung Cancer, EGFR Gene Mutation
- Being tested
- Ultarthin bronchoscopy with intratumoral washing
- Keywords
- Carcinoma, Non-Small-Cell Lung, EGFR Genes, Bronchoscopy, Liquid biopsy, T790M
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultarthin bronchoscopy with intratumoral washingDiagnostic test
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.
| Study group | Role | What they receive |
|---|---|---|
| Ultrathin bronchoscopy with intratumoral washing | Experimental | Each subject with NSCLC will undergo bronchooscopic procedure for EGFR mutation (including T790M positivity) evaluation. Receives: Diagnostic Test: Ultarthin bronchoscopy with intratumoral washing |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: through study completion, an average of 1 year
Secondary outcomes (5)
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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2022
- Study start1 Apr 2022
- Primary completion30 Sep 2023
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non Small Cell Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pusan National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mi-Hyun Kim, PhD, Principal investigator, Pusan National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05517083
- Sponsor's protocol ID
- 2204-006-113
- Status last verified
- Aug 2025
- First submitted
- 30 Jul 2022
- Last updated
- 20 Aug 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of Intratumoral Washing Fluid for Detecting EGFR Mutations in Advanced Non-small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT05517083
- Acronym / sponsor ID
- 2204-006-113
- Conditions
- Non Small Cell Lung Cancer, EGFR Gene Mutation
- Keywords
- Carcinoma, Non-Small-Cell Lung, EGFR Genes, Bronchoscopy, Liquid biopsy, T790M
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Pusan National University HospitalUniversity, hospital or other
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- 30 Sep 2023 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 26 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ultrathin bronchoscopy with intratumoral washing | Experimental | Diagnostic Test: Ultarthin bronchoscopy with intratumoral washingEach subject with NSCLC will undergo bronchooscopic procedure for EGFR mutation (including T790M positivity) evaluation. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ultarthin bronchoscopy with intratumoral washingEach 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. | Diagnostic test | Ultrathin bronchoscopy with intratumoral washing |
Primary outcome
The DNA and EGFR mutation (including T790M positivity) detection rate in intratumoral washing fluid
Time frame: 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.
5 secondary outcomes
The concordance rate of EGFR mutation (including T790M positivity) detection rate among intratumoral washing fluid, plasma, and tissue
Time frame: through study completion, an average of 1 year
The EGFR mutation (including T790M positivity) sensitivity and specificity in intratumoral washing fluid
Time frame: through study completion, an average of 1 year
Objective response rate
Time frame: through study completion, an average of 1 year
Disease control rate
Time frame: through study completion, an average of 1 year
Progression-free survival
Time frame: through study completion, an average of 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mi-Hyun Kim, PhD principal investigator
Pusan National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultarthin bronchoscopy with intratumoral washing in people with Non Small Cell Lung Cancer and EGFR Gene Mutation, run by Pusan National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The DNA and EGFR mutation (including T790M positivity) detection rate in intratumoral washing fluid (time frame: through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2025; AzTrials last refreshed its copy on 8 Nov 2026.