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
Recruiting now Phase 3 NCT07185997
Run by ArriVent BioPharma, Inc. · for 18 and older · All sexes
What this study is about
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.
Who can join (things the study team will check)
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.…
Where this trial is running
- USC/Norris Comprehensive Cancer Center, Los Angeles, California, United States
- University of California Davis Comprehensive Cancer Center, Sacramento, California, United States
- UCSF Medical Center-Mission Bay, San Francisco, California, United States
- Kaiser Permanente Medical Center, Vallejo, California, United States
- University of Colorado Health, Aurora, Colorado, United States
- Illinois Cancer Specialists, Arlington Heights, Illinois, United States
- University of Illinois Hospital and Health Sciences Systems, Chicago, Illinois, United States
- Northwell Health/R.J. Zuckerberg Cancer Center, Lake Success, New York, United States
- Laura & Isaac Perlmutter Cancer Center at NYU Langone Health, New York, New York, United States
- Ohio State University Hospitals, Columbus, Ohio, United States
- Fox Chase Cancer Center, Philadelphia, Pennsylvania, United States
- Texas Oncology, Dallas, Texas, United States
+ 66 more sites.
Who to contact
Vanessa Esquibel · 619-540-3451 · FURMO006CT@arrivent.com
It's completely normal to call and ask questions before deciding anything. Mention the study ID: NCT07185997.
Verify everything on the official ClinicalTrials.gov record. Page updated July 2026.