NCT05548348

First-line Furmonertinib in Advanced NSCLC Patients With EGFR Uncommon Mutation

A Single Arm, Multicenter Study of First-line Furmonertinib Treatment in Patients With Advanced Epidermal Growth Factor Receptor Uncommon Mutation Positive Non-small Cell Lung Cancer

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Chongqing University Cancer Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

Furmonertinib, a newly-designed pan-EGFR-TKI with a trifluoroethoxypyridine-based molecule structure, has shown promising clinical efficacy in EGFR Ex19del/L858R/T790M/Ex20ins mutant advanced NSCLC with an acceptable safety profile without new signals from 80mg to 240mg dose level in phase 1-3 clinical trials. Whether EGFR G719X/S768I/L861Q mutation positive advanced NSCLC patients can benefit from first-line furmonertinib 160mg per day has not been reported. This study aims to investigate the efficacy and safety of furmonertinib 160mg per day in EGFR G719X/S768I/L861Q mutant patients under first-line treatment of advanced NSCLC setting.

Detailed description

This is a single arm, multicenter study which will recruit about 30 patients in China. The study is designed to evaluate the efficacy and safety of furmonertinib in the first-line treatment of patients with EGFR G719X/S768I/L861Q mutations in advanced NSCLC. Furmonertinib will be administered orally at a dose of 160 mg per time, Q.D.

Conditions

• Non-small Cell Lung Cancer
• EGFR G719X
• EGFR L861Q
• EGFR S768I

Interventions

Type	Name	Description
DRUG	Furmonertinib 160 mg, Q.D.	Furmonertinib will be administered orally at a dose of 160 mg per time, Q.D.

Timeline

• Start date: 2022-09-26
• Primary completion: 2023-12-31
• Completion: 2025-10-31
• First posted: 2022-09-21
• Last updated: 2022-09-21

Locations

3 sites across 1 country: China