NCT03969823

Whole Genomic Landscape of Advanced EGFR-mutant NSCLC

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

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 148 (estimated)
• Sponsor: Seoul National University Hospital · Academic / Other
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Locally Advanced or Metastatic NSCLC

Interventions

Type	Name	Description
DRUG	Tagrisso	Osimertinib 80mg once daily until disease progression

Timeline

• Start date: 2019-05-23
• Primary completion: 2025-09-30
• Completion: 2025-12-31
• First posted: 2019-05-31
• Last updated: 2025-05-15

Locations

3 sites across 1 country: South Korea