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
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
In brief
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.
Key facts
- Study ID
- NCT07185997
- Run by
- ArriVent BioPharma, Inc.
- People needed
- 480
- Starts
- 2025-12-17
- Expected to finish
- 2030-12-01
- Last updated by the study team
- 2026-08-03
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- USC/Norris Comprehensive Cancer Center — Los Angeles, California, United States (enrolling)
- Providence St. Joseph Hospital — Orange, California, United States (enrolling)
- University of California Davis Comprehensive Cancer Center — Sacramento, California, United States (enrolling)
- UCSF Medical Center-Mission Bay — San Francisco, California, United States (enrolling)
- Kaiser Permanente Medical Center — Vallejo, California, United States (enrolling)
- University of Colorado Health — Aurora, Colorado, United States (enrolling)
- Illinois Cancer Specialists — Arlington Heights, Illinois, United States (enrolling)
- University of Illinois Hospital and Health Sciences Systems — Chicago, Illinois, United States (enrolling)
- Henry Ford Cancer Institute — Detroit, Michigan, United States (enrolling)
- Northwell Health/R.J. Zuckerberg Cancer Center — Lake Success, New York, United States (enrolling)
- Laura & Isaac Perlmutter Cancer Center at NYU Langone Health — New York, New York, United States (enrolling)
- Ohio State University Hospitals — Columbus, Ohio, United States (enrolling)
- Fox Chase Cancer Center — Philadelphia, Pennsylvania, United States (enrolling)
- Texas Oncology — Dallas, Texas, United States (enrolling)
- The University of Texas MD Anderson Cancer Center — Houston, Texas, United States (enrolling)
- University of Virginia — Charlottesville, Virginia, United States (enrolling)
- Virginia Cancer Specialists — Fairfax, Virginia, United States (enrolling)
- Shenandoah Oncology, P.C. — Winchester, Virginia, United States (enrolling)
- Swedish Cancer Institute — Edmonds, Washington, United States (enrolling)
- Blacktown Cancer and Haematology Centre — Blacktown, New South Wales, Australia (enrolling)
- Chris O'Brien Lifehouse — Camperdown, New South Wales, Australia (enrolling)
- GenesisCare North Shore Health Hub — St Leonards, New South Wales, Australia (enrolling)
- Austin Health — Heidelberg, Victoria, Australia (enrolling)
- Alberta Health Services, Tom Baker Cancer Centre — Calgary, Alberta, Canada (enrolling)
- St. Jude Medical Center — Fullerton, California, United States (enrolling)
Full record on ClinicalTrials.gov
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