NCT07185997

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

A Global, Phase 3, Randomized, Multicenter, Open-Label Study to Evaluate the Efficacy and Safety of Firmonertinib Compared With Investigator's Choice of Osimertinib or Afatinib as First-Line Treatment in Participants Who Have Locally Advanced or Metastatic Non-Small-Cell Lung Cancer With Epidermal Growth Factor Receptor P-Loop and Alpha C-Helix Compressing (PACC) Uncommon Mutations (ALPACCA)

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 480 (estimated)
• Sponsor: ArriVent BioPharma, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• 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

Interventions

Type	Name	Description
DRUG	Firmonertinib	240 mg oral, daily firmonertinib tablet
DRUG	EGFR-TKI inhibitor based on investigator's choice	osimertinib 80 mg oral, daily tablet OR afatinib 40 mg oral, daily tablet

Timeline

• Start date: 2025-12-17
• Primary completion: 2029-02-01
• Completion: 2030-12-01
• First posted: 2025-09-22
• Last updated: 2026-04-16

Locations

56 sites across 13 countries: United States, Australia, Canada, Greece, Hong Kong, Italy, Japan, Malaysia, Singapore, South Korea, Spain, Taiwan, United Kingdom

Regulatory

• FDA-regulated drug study