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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
Sponsor: ArriVent BioPharma, Inc.
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.
Official title: 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)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
480
Start Date
2025-12-17
Completion Date
2030-12
Last Updated
2026-04-06
Healthy Volunteers
No
Conditions
Interventions
Firmonertinib
240 mg oral, daily firmonertinib tablet
EGFR-TKI inhibitor based on investigator's choice
osimertinib 80 mg oral, daily tablet OR afatinib 40 mg oral, daily tablet
Locations (54)
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
Illinois Cancer Specialists
Arlington Heights, Illinois, United States
University of Illinois Hospital and Health Sciences Systems
Chicago, Illinois, United States
Laura & Isaac Perlmutter Cancer Center at NYU Langone Health
New York, New York, United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States
Texas Oncology
Dallas, Texas, United States
The University of Texas MD Anderson Cancer Center
Houston, Texas, United States
University of Virginia
Charlottesville, Virginia, United States
Virginia Cancer Specialists
Fairfax, Virginia, United States
Shenandoah Oncology, P.C.
Winchester, Virginia, United States
Blacktown Cancer and Haematology Centre
Blacktown, New South Wales, Australia
Chris O'Brien Lifehouse
Camperdown, New South Wales, Australia
GenesisCare North Shore Health Hub
St Leonards, New South Wales, Australia
Austin Health
Heidelberg, Victoria, Australia
Sunnybrook Research Institute
Toronto, Ontario, Canada
Henry Dunant Hospital Center
Athens, Greece
Athens Medical Center S.A., European Interbalkan Medical Center
Thessaloniki, Greece
Thoracic General Hospital of Athens I Sotiria
Thessaloniki, Greece
Humanity and Health Clinical Trial Centre
Central, Hong Kong
Queen Mary Hospital
Hong Kong, Hong Kong
SOC Oncologia Medica e dei Tumori Immuno-correlati
Aviano, Italy
Istituto Europeo di Oncologia (IEO)
Milan, Italy
Aichi Cancer Center
Nagoya, Aichi-ken, Japan
Kurume University Hospital
Kurume-Shi, Fukuoka, Japan
National Hospital Organization Hokkaido Cancer Center
Sapporo, Hokkaido, Japan
Hyogo Cancer Center
Akashi-shi, Hyōgo, Japan
Miyagi Cancer Center
Natori-shi, Miyagi, Japan
Niigata Cancer Center Hospital
Niigata, Niigata, Japan
Kansai Medical University Hospital
Hirakata-shi, Osaka, Japan
Nippon Medical School Hospital
Bunkyo-ku, Tokyo, Japan
Tokyo Metropolitan Komagome Hospital
Bunkyō-Ku, Tokyo, Japan
National Cancer Center Hospital
Chuo-ku, Tokyo, Japan
Hospital Kuala Lumpur
Kuala Lumpur, WP Kuala Lumpur, Malaysia
National Cancer Centre Singapore
Singapore, Singapore
Curie Oncology (Farrer)
Singapore, Singapore
Tan Tok Seng Hospital
Singapore, Singapore
The Catholic University of Korea, St. Vincent's Hospital
Suwon, Gyeonggi-do, South Korea
Chonnam National University Hwasun Hospital
Hwasun, Jeollanam-do, South Korea
Gachon University Gil Medical Center
Incheon, South Korea
Kangbuk Samsung Hospital
Seoul, South Korea
Asan Medical Center
Seoul, South Korea
Samsung Medical Center
Seoul, South Korea
Hospital Universitari Son Espases
Palma, Balearic Islands, Spain
Hospital Clinic de Barcelona
Barcelona, Spain
Hospital QuironSalud Malaga
Málaga, Spain
Hospital Universitario y Politecnico La Fe
Valencia, Spain
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, Taiwan
Taichung Veterans General Hospital
Taichung, Taiwan
University College London Hospitals NHS Foundation Trust
London, England, United Kingdom
The Christie NHS Foundation Trust
Manchester, England, United Kingdom
The Royal Marsden NHS Foundation Trust
London, United Kingdom