Whole Genomic Landscape of Advanced EGFR-mutant NSCLC

  • End date
    Dec 31, 2023
  • participants needed
  • sponsor
    Seoul National University Hospital
Updated on 24 March 2021


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-nave NSCLC patients with EGFR-activating mutations who receive a first-line osimertinib orally at a dose of 80mg once daily.


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 nave 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.

Condition Locally Advanced or Metastatic NSCLC
Treatment Tagrisso
Clinical Study IdentifierNCT03969823
SponsorSeoul National University Hospital
Last Modified on24 March 2021

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