Recruiting INTERVENTIONAL 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)

Sponsor: ArriVent BioPharma, Inc.

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

Interventions EGFR-TKI inhibitor based on investigator's choice Firmonertinib

Updated 5 times since 2025 Last updated: Apr 14, 2026 Started: Dec 17, 2025 Primary completion: Feb 1, 2029 Completion: Dec 1, 2030

This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

A observational or N/A phase clinical study on Advanced Non-Small-Cell Lung Cancer and EGFR P-Loop and Alpha C-Helix Compressing, this trial is actively recruiting participants. The trial is conducted by ArriVent BioPharma, Inc. and has accumulated 5 data snapshots since 2025. Oncology trials at this stage typically focus on safety, tolerability, and early efficacy signals.

Status Flow

Change History

5 versions recorded

Apr 17, 2026 — Present [daily]

Recruiting

Phase: PHASE3 → None
Feb 2026 — Apr 2026 [monthly]

Recruiting PHASE3
Dec 2025 — Feb 2026 [monthly]

Recruiting PHASE3
Nov 2025 — Dec 2025 [monthly]

Recruiting PHASE3

Status: Not Yet Recruiting → Recruiting
Oct 2025 — Nov 2025 [monthly]

Not Yet Recruiting PHASE3

First recorded

Eligibility 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.

Contact Information

Sponsor contact:

ArriVent BioPharma, Inc.

Data source: ClinicalTrials.gov

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations

Akashi-shi, Japan , Arlington Heights, United States , Athens, Greece , Aviano, Italy , Barcelona, Spain , Blacktown, Australia , Bunkyo-ku, Japan , Bunkyō-Ku, Japan , Camperdown, Australia , Central, Hong Kong and 46 more locations