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
Start Date
12/17/2025
Completion Date
12/1/2030
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.
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
Firmonertinib
EGFR-TKI inhibitor based on investigator's choice
Conditions
Locations
USC/Norris Comprehensive Cancer Center
Los Angeles, California 90033
United States
University of California Davis Comprehensive Cancer Center
Sacramento, California 95817
United States
UCSF Medical Center-Mission Bay
San Francisco, California 94158
United States
Kaiser Permanente Medical Center
Vallejo, California 94589
United States
University of Colorado Health
Aurora, Colorado 80045
United States
Illinois Cancer Specialists
Arlington Heights, Illinois 60005
United States
University of Illinois Hospital and Health Sciences Systems
Chicago, Illinois 60612
United States
Northwell Health/R.J. Zuckerberg Cancer Center
Lake Success, New York 11042
United States
Laura & Isaac Perlmutter Cancer Center at NYU Langone Health
New York, New York 10016
United States
Ohio State University Hospitals
Columbus, Ohio 43210
United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania 19111
United States
Texas Oncology
Dallas, Texas 75246
United States
The University of Texas MD Anderson Cancer Center
Houston, Texas 77030
United States
University of Virginia
Charlottesville, Virginia 22903
United States
Virginia Cancer Specialists
Fairfax, Virginia 22031
United States
Shenandoah Oncology, P.C.
Winchester, Virginia 22601
United States
Swedish Cancer Institute
Edmonds, Washington 98026
United States
Blacktown Cancer and Haematology Centre
Blacktown, New South Wales 2148
Australia
Chris O'Brien Lifehouse
Camperdown, New South Wales 2050
Australia
GenesisCare North Shore Health Hub
St Leonards, New South Wales 2065
Australia
Austin Health
Heidelberg, Victoria 3084
Australia
Alberta Health Services, Tom Baker Cancer Centre
Calgary, Alberta T2N 4N2
Canada
BC Cancer Vancouver Centre
Vancouver, British Columbia V5Z 4E6
Canada
The Ottawa Hospital Cancer Centre
Ottawa, Ontario K1H 8L6
Canada
Sunnybrook Research Institute
Toronto, Ontario M4N 3M5
Canada
Princess Margaret Cancer Centre - University Health Network
Toronto, Ontario M5G 2M9
Canada
Hospices Civil de Lyon
Bron, Auvergne-Rhône-Alpes 69500
France
Hospital Nord de Marseille
Marseille, Bouches-du-Rhone 13915
France
Centre Francois Baclesse
Caen, Calvados 14076
France
Hopital Larrey
Toulouse, Occitanie 31059
France
Centre Leon-Berard
Lyon, 69373
France
Hopital Nord Guilaume-et-Rene-Laennec CHU de Nantes
Saint-Herblain, 44093
France
Insitut de Canderologie d I'Ouest
Saint-Herblain, 44805
France
Henry Dunant Hospital Center
Athens, 115 26
Greece
University General Hospital Attikon - General Hospital of West Attica H AGIA VARVARA
Athens, 124 62
Greece
Athens Medical Center S.A., European Interbalkan Medical Center
Thessaloniki, 570 01
Greece
Thoracic General Hospital of Athens I Sotiria
Thessaloniki, 570 01
Greece
Queen Mary Hospital
Hong Kong, Hong Kong 000000
Hong Kong
Humanity and Health Clinical Trial Centre
Central,
Hong Kong
SOC Oncologia Medica e dei Tumori Immuno-correlati
Aviano, 33081
Italy
Istituto Europeo di Oncologia (IEO)
Milan, 20141
Italy
Aichi Cancer Center
Nagoya, Aichi-ken 464-8681
Japan
Kurume University Hospital
Kurume-Shi, Fukuoka 830-0011
Japan
National Hospital Organization Hokkaido Cancer Center
Sapporo, Hokkaido 003-0804
Japan
Hyogo Cancer Center
Akashi-shi, Hyōgo 673-8558
Japan
Miyagi Cancer Center
Natori-shi, Miyagi 981-1293
Japan
Niigata Cancer Center Hospital
Niigata, Niigata 951-8566
Japan
Kansai Medical University Hospital
Hirakata-shi, Osaka 573-1191
Japan
Nippon Medical School Hospital
Bunkyo-ku, Tokyo 113-8603
Japan
Tokyo Metropolitan Komagome Hospital
Bunkyō-Ku, Tokyo 113-8677
Japan
National Cancer Center Hospital
Chuo-ku, Tokyo 104-0045
Japan
OncoCar Cancer Centre
Petaling Jaya, Selangor 47810
Malaysia
Hospital Kuala Lumpur
Kuala Lumpur, WP Kuala Lumpur 50586
Malaysia
National Cancer Centre Singapore
Singapore, 168583
Singapore
Curie Oncology (Farrer)
Singapore, 217562
Singapore
Tan Tok Seng Hospital
Singapore, 308433
Singapore
The Catholic University of Korea, St. Vincent's Hospital
Suwon, Gyeonggi-do 16247
South Korea
Chonnam National University Hwasun Hospital
Hwasun, Jeollanam-do 58128
South Korea
Gachon University Gil Medical Center
Incheon, 21565
South Korea
Kyung Hee University Hospital
Seoul, 02447
South Korea
Kangbuk Samsung Hospital
Seoul, 03181
South Korea
Asan Medical Center
Seoul, 05505
South Korea
Samsung Medical Center
Seoul, 06351
South Korea
Hospital Universitari Son Espases
Palma, Balearic Islands 07120
Spain
Hospital Clinic de Barcelona
Barcelona, 08036
Spain
Hospital QuironSalud Malaga
Málaga, 29004
Spain
Hospital Universitario Central de Asturias
Oviedo, 33011
Spain
Hospital Universitario y Politecnico La Fe
Valencia, 46026
Spain
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, 807
Taiwan
Taichung Veterans General Hospital
Taichung, 407219
Taiwan
National Taiwan University Cancer Center
Taipei, 106
Taiwan
Taipei Veterans General Hospital
Taipei, 11217
Taiwan
Mahidol University - Siriraj Hospital
Bangkoknoi, Bangkok 10700
Thailand
Chulabhorn Hospital
Lak Si, Bangkok 10210
Thailand
Prince of Songkla Hospital
Hat Yai, Changwat Songkhla 90110
Thailand
University College London Hospitals NHS Foundation Trust
London, England NW1 2PG
United Kingdom
The Christie NHS Foundation Trust
Manchester, England M20 4BX
United Kingdom
The Royal Marsden NHS Foundation Trust
London, SW3 6JJ
United Kingdom