Firmonertinib Versus Platinum Based Chemotherapy as First-line Treatment for NSCLC With EGFR PACC or EGFR l861q Mutation

This study is a randomized, open, multicenter phase III clinical study, which aims to evaluate the efficacy and safety of firmonertinib mesylate compared with platinum based chemotherapy for patients with locally advanced or metastatic NSCLC who have not been treated with systemic antitumor therapy and carry EGFR PaCC mutation or EGFR l861q mutation. Eligible patients were stratified by EGFR mutation type and CNS metastasis at the time of enrollment. Approximately 300 patients would be randomly assigned 1:1 to receive either firmonertinib mesylate (240mg, orally on an empty stomach daily) or platinum containing dual agent chemotherapy.

NCT Number	NCT06956001
Lead Sponsor	Allist Pharmaceuticals, Inc.
Conditions	EGFR, NSCLC (Advanced Non-small Cell Lung Cancer)
Enrollment	300 participants
Start Date	2024-11-19
Primary Completion	2027-12 (estimated)
Study Completion	2028-07 (estimated)
Updated on ClinicalTrials.gov	2026-08-13