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 (NCT07185997)
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)
🩺 Plain-English Summary (8th-Grade Level)
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: Review the eligibility criteria below.
Location: St. Jude Medical Center — Fullerton, California
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (88 Sites)
Showing the first 25 of 88 sites.
- St. Jude Medical Center — Fullerton, California
- USC/Norris Comprehensive Cancer Center — Los Angeles, California
- Providence St. Joseph Hospital — Orange, California
- University of California Davis Comprehensive Cancer Center — Sacramento, California
- UCSF Medical Center-Mission Bay — San Francisco, California
- Kaiser Permanente Medical Center — Vallejo, California
- University of Colorado Health — Aurora, Colorado
- Illinois Cancer Specialists — Arlington Heights, Illinois
- University of Illinois Hospital and Health Sciences Systems — Chicago, Illinois
- Henry Ford Cancer Institute — Detroit, Michigan
- Northwell Health/R.J. Zuckerberg Cancer Center — Lake Success, New York
- Laura & Isaac Perlmutter Cancer Center at NYU Langone Health — New York, New York
- Ohio State University Hospitals — Columbus, Ohio
- Fox Chase Cancer Center — Philadelphia, Pennsylvania
- Texas Oncology — Dallas, Texas
- The University of Texas MD Anderson Cancer Center — Houston, Texas
- University of Virginia — Charlottesville, Virginia
- Virginia Cancer Specialists — Fairfax, Virginia
- Shenandoah Oncology, P.C. — Winchester, Virginia
- Swedish Cancer Institute — Edmonds, Washington
- Blacktown Cancer and Haematology Centre — Blacktown, New South Wales
- Chris O'Brien Lifehouse — Camperdown, New South Wales
- GenesisCare North Shore Health Hub — St Leonards, New South Wales
- Austin Health — Heidelberg, Victoria
- Alberta Health Services, Tom Baker Cancer Centre — Calgary, Alberta
📞 Contact the Study Coordinator
Phone: (888) 622-2827
Email: FURMO006CT@arrivent.com
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
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Explore by condition: All Non-Small-Cell Lung Cancer clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.