NCT03804580

First-line Treatment With Osimertinib in EGFR-mutated Non-small Cell Lung Cancer

First-line Treatment With Osimertinib in EGFR-mutated Non-small Cell Lung Cancer, Coupled to Extensive Translational Studies

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: Vestre Viken Hospital Trust · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Phase II, single-arm study to assess the safety and efficacy of osimertinib (80 mg, orally, once daily) as first-line therapy in patients with EGFR mutation-positive, locally advanced or metastatic non-small cell lung cancer (NSCLC) who have not previously treated with an epidermal growth factor tyrosine kinase inhibitor agent.

Detailed description

This is a phase II, single-arm study to assess the safety and efficacy of osimertinib (80 mg, orally, once daily) as first-line therapy in patients with EGFR mutation-positive, locally advanced or metastatic non-small cell lung cancer (NSCLC) who have not previously treated with an epidermal growth factor tyrosine kinase inhibitor agent. Subjects will have to provide a biopsy sample (fresh or archival) for molecular testing at inclusion. If feasible, a biopsy will also be sampled when partial response is achieved and at the time of disease progression on osimertinib. Liquid biopsies will be sampled throughout the treatment period. Subjects should continue on study treatment until RECIST 1.1-defined progression or until a treatment criterion is met. There is no maximum duration of treatment as subjects may continue to receive investigational product beyond RECIST1.1-defined progression as long as they are continuing to show clinical benefit, as judged by the investigator.

Conditions

• Lung Cancer

Interventions

Type	Name	Description
DRUG	osimertinib	Non-randomized trial, all patients receive therapy

Timeline

• Start date: 2018-12-01
• Primary completion: 2025-06-01
• Completion: 2025-12-31
• First posted: 2019-01-15
• Last updated: 2024-05-07

Locations

10 sites across 4 countries: Denmark, Lithuania, Norway, Sweden