Using intratumoral washing to detect EGFR mutations in lung cancer
Feasibility of Intratumoral Washing Fluid for Detecting EGFR Mutations in Advanced Non-small Cell Lung Cancer
This study is testing a new way to find specific gene changes in lung cancer patients who have already been treated, to see if washing the tumor with a special technique can help detect these changes more accurately.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 70 (estimated) |
| Ages | 20 Years and up |
| Sex | All |
| Sponsor | Pusan National University Hospital Academic / other |
| Drugs / interventions | gefitinib, erlotinib, afatinib, dacomitinib |
| Locations | 1 site (Busan) |
| Trial ID | NCT05517083 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of intratumoral washing using ultrathin bronchoscopy to detect EGFR mutations, including T790M, in patients with non-small cell lung cancer (NSCLC). It is a prospective, single-arm, open-label approach that employs advanced PCR techniques to analyze the washing fluid for genetic mutations. The goal is to determine if this method can provide accurate mutation detection in patients who have previously undergone treatment with EGFR-TKIs and are now experiencing disease progression.
Who should consider this trial
Good fit: Ideal candidates are patients aged 20 and older with inoperable stage IV NSCLC who have specific EGFR mutations and have previously been treated with EGFR-TKIs.
Not a fit: Patients who are unable to undergo liquid or tissue biopsy for EGFR mutation testing may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to more accurate detection of EGFR mutations, enabling better-targeted therapies for lung cancer patients.
How similar studies have performed: While this approach is innovative, similar studies using liquid biopsies for mutation detection have shown promise, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Busan
- Pusan National University hospital — Busan, Korea, Republic of (Recruiting)
Study contacts
- Principal investigator: Mi-Hyun Kim, PhD — Pusan National University Hospital
- Study coordinator: Mi-Hyun Kim, MD, PhD
- Email: mihyunkim@pusan.ac.kr
- Phone: 82 51 240 7889
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.