A Next-generation Sequencing Analysis to Investigate the Clinical Impact of Concomitant Genetic Alterations in the Patients With Advanced EGFR-mutated Lung Adenocarcinoma: A Multicenter Study.
| Registry | NCT04122833 |
|---|---|
| Status | Unknown |
| Study type | Observational |
| Enrollment | 80 (Estimated) |
| Sponsor | Konkuk University Medical Center (Other); collaborators: Roche Diagnostics GmbH, Foundation Medicine |
| Conditions | Adenocarcinoma of Lung, EGFR Activating Mutation |
| Interventions | Next generation sequencing (Other) |
| Dates | start 2019-09-30, primary completion 2023-09-30 (estimated), completion 2024-12-31 (estimated), first posted 2019-10-10, last updated 2022-08-18 |
| Locations | 2 sites in South Korea |
Related Papers Related Patents Related Grants Related Experts
All trials for Adenocarcinoma of Lung All trials for EGFR Activating Mutation All trials of Next generation sequencing
The concomitant co-mutation with epidermal growth factor receptor (EGFR) mutation might influence the clinical outcomes. The investigators will identify the impact of concommitant mutation on clinical outcome in patients with advanced -EGFR mutated adenocarcinoma.
The investigators will compare the genetic alterations between tumors of pre and post Tyrosin Kinase Inhibitor(TKI) treatments and predict the resistance mechanism for EGFR-TKIs by next-generation sequencing(NGS) analysis.
The current standard therapies in the treatment of advanced EGFR-mutated lung cancer patients are the 1st or 2nd EGFR-TKIs. Although 70-80% of patients treated by EGFR-TKIS show good responses, they have progression after around 12 months. The concomitant co-mutation with EGFR mutation might influence the drug response of EGFR TKI. The investigators will compare the progression-free survival (PFS) of EGFR-TKI according to co-occuring mutations.
The patients experience the change of molecular profiles after using the TKI. Therefore, the investigators will investigate the molecular profiles through NGS panel with foundation medicine in the tissue of pre/post EGFR-TKI, compare the change of the molecular profiles and tumor mutation burden(TMB), and identify novel mechanisms of drug resistance.
The investigators will collect the tumor tissues and blood of around 80 patients in multi-centers prospectively. Then, They will be sent to FoundationOne in the US and perform NGS analysis. The type of EGFR-TKIs would be selected according to physicians' preference. NGS will be performed twice before the EGFR-TKIs treatment and after the progression.
Sex: All, ages: 19 Years to any
Inclusion Criteria: 1. Signed Informed Consent Form 2. Age ≥19 years 3. EGFR-mutated stage IV lung adenocarcinoma patients 4. Archival biopsy tissues which are from core needle biopsies, endobronchial ultrasound (EBUS) guided- lymph node biopsy or lymph node excisional biopsy at baseline and at radiologic progression 5. Availability of the 10 unstained slides and 1 H\&E slides at pre/ post TKI treatment 6. Samples should contain a minimum of 20% viable tumor cells that preserve Exclusion Criteria: Tumor tissue from bone metastases that have been decalcified are not acceptable. \-
| Facility | City | Country | Status |
|---|---|---|---|
| Asan medical center | Seoul | South Korea | Recruiting |
| Catholic university medical center, Seoul St. Mary's Hospital | Seoul | South Korea | Not yet recruiting |