Whole Genomic Landscape of Advanced EGFR-mutant NSCLC
- Sponsor
- Seoul National University Hospital
- Study ID
- NCT03969823
- Status
- Active Not Recruiting
Conditions
- Locally Advanced or Metastatic NSCLC
Eligibility Criteria
- Sex
- ALL
- Age
- 19 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Tagrisso — DRUGOsimertinib 80mg once daily until disease progression
Study Details
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.
Key Dates
- Start date
- May 23, 2019
- Status verified
- Apr 2026
- Primary completion
- Sep 30, 2026
- Completion
- Dec 31, 2026
Study Design
- Enrollment
- 148 participants (estimated)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- OTHER
Arms
- Experimental: OsimertinibOsimertinib at 80mg dose will be administered orally once daily.
Primary Outcome Measure
Proportion of acquired resistance mechanisms to osimertinib at disease progression [ Time Frame: Through study completion, an average of 2 years ]