Feasibility of Intratumoral Washing Fluid for Detecting EGFR Mutations in Lung Cancer

Launched by PUSAN NATIONAL UNIVERSITY HOSPITAL · Aug 25, 2022

Keywords

ClinConnect Summary

This clinical trial is looking at a new way to detect specific mutations in the EGFR gene in patients with non-small cell lung cancer (NSCLC). The researchers want to see if using a washing fluid from the tumor itself can help find these mutations, including a specific one called T790M, which can affect treatment options. The study is currently recruiting participants who are at least 20 years old, have been diagnosed with advanced NSCLC that cannot be surgically removed, and have certain EGFR mutations.

To be eligible, participants should have previously received treatment with certain drugs for their cancer and showed some benefit from those treatments before their condition worsened. They will need to provide consent to participate and be willing to undergo tests that involve taking samples from their blood and tumor. If you or someone you know meets these criteria, this trial may offer a chance to help improve the understanding of how to detect important gene mutations in lung cancer.

Gender

ALL

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