drugset / Trial / NCT05548348

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

NCT05548348

NaSingle-groupOpen-labelTreatment

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.

Timeline

Start
2022-09-26
Primary completion
2023-12-31
Completion
2025-10-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Firmonertinib Small molecule 160 mg Oral