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Whole Genomic Landscape of Advanced EGFR-mutant NSCLC

Locally Advanced or Metastatic NSCLC Clinical Trial

Official title:
Whole Genomic Landscape of EGFR Mutation-Positive Advanced Non-Small Cell Lung Cancer Treated With First-Line Osimertinib (WARRIOR)

Clinical Trial Summary

This is a phase 2 single-arm, non-randomized multicentre and tissue acquisition study to evaluate acquired resistance mechanisms, efficacy, and safety in advanced, EGFR tyrosine kinase inhibitor-naïve NSCLC patients with EGFR-activating mutations who receive a first-line osimertinib orally at a dose of 80mg once daily.

Clinical Trial Description

This open-label, single-arm, non-randomized phase 2 exploratory study has been designed to evaluate the mechanisms of resistance to first-line osimertinib 80mg once daily in NSCLC patients with EGFR-activating mutation who were naïve to chemotherapy as well as EGFR TKIs. Acquired resistance to first-line osimertinib is mediated by heterogeneous mechanisms including MET amplification (15%), secondary EGFR mutation including C797S or S768I (7%), PIK3CA mutation (7%), CDK4/6 amplification (5%), KRAS mutation (3%), BRAF mutation (3%), CCND1-3 amplification (3%), CCNE1 amplification (2%), HER2 amplification (2%), and SPTBN1-ALK fusion (1%) using plasma genotyping of FLAURA study (N=91). Therefore, this study is necessary to evaluate resistance mechanisms of ≥1% to first-line osimertinib in NSCLC patients with EGFR-activating mutations using whole-genomic profiling of tumours at pre-treatment and progression which acquisitions are mandatory. ;

Study Design

Related Conditions & MeSH terms

  • Locally Advanced or Metastatic NSCLC
Clinical Trial Details
NCT number NCT03969823
Study type Interventional
Source Seoul National University Hospital
Contact
Status Active, not recruiting
Phase N/A
Start date May 23, 2019
Completion date December 31, 2025
View Details
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