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

Lung Cancer Clinical Trial

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

Status Active, not recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Lung Cancer
• Lung Neoplasms

• NCT number: NCT03804580
• Study type: Interventional
• Source: Vestre Viken Hospital Trust
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: December 1, 2018
• Completion date: December 31, 2025