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
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.
Checked against the public recordLast updated Aug 3, 2026 · Source: ClinicalTrials.gov
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 3
- Sponsor
- ArriVent BioPharma, Inc.
- Interventions being studied
- Drug: Firmonertinib; Drug: EGFR-TKI inhibitor based on investigator's choice
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
Key Eligibility Criteria: * Histologically or cytologically documented, locally advanced or metastatic Non-Small Cell Lung Cancer (NSCLC) not amenable to curative surgery or radiotherapy. * Documented results of the presence of an Epidermal Growth Factor Receptor (EGFR) PACC mutation in tumor tissue or blood from local testing. * No prior systemic anticancer therapy regimens received for locally advanced or metastatic Non-Small Cell Lung Cancer (NSCLC) including prior treatment with any Epidermal Growth Factor Receptor (EGFR)-targeting agents (e.g., previous (EGFR) TKIs, monoclonal antibodies, or bispecific antibodies). * Patients who have received prior neo-adjuvant and/or adjuvant chemotherapy, immunotherapy, or chemo radiotherapy for non-metastatic disease must have experienced a treatment free interval of at least 12 months. * Patients with asymptomatic CNS metastases are eligible.
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- St. Jude Medical CenterFullerton, California
- USC/Norris Comprehensive Cancer CenterLos Angeles, California
- Providence St. Joseph HospitalOrange, California
- University of California Davis Comprehensive Cancer CenterSacramento, California
- UCSF Medical Center-Mission BaySan Francisco, California
- Kaiser Permanente Medical CenterVallejo, California
- University of Colorado HealthAurora, Colorado
- Illinois Cancer SpecialistsArlington Heights, Illinois
- University of Illinois Hospital and Health Sciences SystemsChicago, Illinois
- Henry Ford Cancer InstituteDetroit, Michigan
- Northwell Health/R.J. Zuckerberg Cancer CenterLake Success, New York
- Laura & Isaac Perlmutter Cancer Center at NYU Langone HealthNew York, New York
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Aug 3, 2026. Always confirm current availability with the study team.