Study to Evaluate Efficacy and Safety of Firmonertinib Compared With Investigator's Choice of EGFR Inhibitor as First-Line Treatment in Participants Who Have Locally Advanced or Metastatic NSCLC With EGFR P-Loop and Alpha C-Helix Compressing (PACC) Uncommon Mutations

Summary

Global, Phase 3, randomized, multicenter, open-label study evaluating the efficacy and safety of firmonertinib at a dose level of 240 mg QD compared to investigator's choice of osimertinib (80 mg QD) or afatinib (40 mg QD) in participants who have locally advanced or metastatic NSCLC with EGFR PACC mutations, and who have not received any prior therapy for advanced disease. Participants will be randomized in a 1:1 ratio to treatment with firmonertinib or osimertinib or afatinib and will take the assigned dose daily.

Shortened from the sponsor's brief summary. View official record on ClinicalTrials.gov

Conditions studied

• Non-Small-Cell Lung Cancer
• Metastatic Non-Small-Cell Lung Cancer
• Advanced Non-Small-Cell Lung Cancer
• EGFR P-Loop and Alpha C-Helix Compressing
• EGFR PACC
• EGFR Uncommon Mutations

Eligibility basics and study details

Study type

Interventional

Phase

Phase 3

Ages

18 years and older

Sex

All

Healthy volunteers

Not accepted

Sponsor

ArriVent BioPharma, Inc.

Last updated on ClinicalTrials.gov

October 14, 2026

These are the basic criteria only. The full inclusion and exclusion criteria are on the official record, and the study team decides who can take part.

US recruiting sites