Clinical trial · Interventional
Feasibility of Intratumoral Washing Fluid for Detecting EGFR Mutations in Lung Cancer
Feasibility of Intratumoral Washing Fluid for Detecting EGFR Mutations in Advanced Non-small Cell Lung Cancer
NCT05517083CI-TRIAL-00093896completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to evaluate the relevance of intratumoral washing for detection of EGFR mutation (including T790M positivity).
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| EGFR Gene Mutation | — | UNRESOLVED | — |
| Non Small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Ultarthin bronchoscopy with intratumoral washing | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Ultrathin bronchoscopy with intratumoral washing
- description
- Each subject with NSCLC will undergo bronchooscopic procedure for EGFR mutation (including T790M positivity) evaluation.
- interventionNames
- Diagnostic Test: Ultarthin bronchoscopy with intratumoral washing
Primary outcomes (1)
- measure
- The DNA and EGFR mutation (including T790M positivity) detection rate in intratumoral washing fluid
- timeFrame
- through study completion, an average of 1 year
- description
- 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 outcomes (5)
- measure
- The concordance rate of EGFR mutation (including T790M positivity) detection rate among intratumoral washing fluid, plasma, and tissue
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.