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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
2026-11-02
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 (141)
St. Jude Medical Center
Fullerton, California, United States
USC/Norris Comprehensive Cancer Center
Los Angeles, California, United States
Providence St. Joseph Hospital
Orange, 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
Henry Ford Cancer Institute
Detroit, Michigan, 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
Columbia University Medical Center
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
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
Swedish Cancer Institute
Edmonds, Washington, 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
Alberta Health Services, Tom Baker Cancer Centre
Calgary, Alberta, Canada
University of Alberta - Cross Cancer Institute (CCI)
Edmonton, Alberta, Canada
BC Cancer Vancouver Centre
Vancouver, British Columbia, Canada
Brampton Civic Hospital, William Osler Health Centre
Brampton, Ontario, Canada
The Ottawa Hospital Cancer Centre
Ottawa, Ontario, Canada
Sunnybrook Research Institute
Toronto, Ontario, Canada
Princess Margaret Cancer Centre - University Health Network
Toronto, Ontario, Canada
Anhui Provincial Hospital
Hefei, Anhui, China
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China
Peking University People's Hospital
Beijing, Beijing Municipality, China
Peking University Cancer Hospital (PKUCH)/Beijing Cancer Hospital
Beijing, Beijing Municipality, China
Beijing Chest Hospital, Capital Medical University
Beijing, Beijing Municipality, China
The First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China
Fujian Cancer Hospital
Fuzhou, Fujian, China
Zhongshan Hospital Xiamen University
Xiamen, Fujian, China
The First People's Hospital of Foshan
Foshan, Guangdong, China
The First Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong, China
Nanfang Hospital, Southern Medical University
Guangzhou, Guangdong, China
Cancer Hospital of Shantou University Medical College
Shantou, Guangdong, China
Guangxi Medical University Cancer Hospital
Nanning, Guangxi, China
The Fourth Hospital of Hebei Medical University
Shijiazhuang, Hebei, China
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, China
The First Affiliated Hospital of Henan University of Science & Technology
Luoyang, Henan, China
The First Affiliated Hospital of Henan Medical University
Xinxiang, Henan, China
Henan Cancer Center
Zhengzhou, Henan, China
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
Union Hospital Tongji Medical College Huazhong University Of Science And Technology
Wuhan, Hubei, China
Xiangya Hospital of Central South University
Changsha, Hunan, China
Hunan Cancer Hospital
Changsha, Hunan, China
Profile of The Third Xiangya Hospital of Central South University
Changsha, Hunan, China
The Affiliated Hospital of Inner Mongolia Medical University
Hohhot, Inner Mongolia, China
Jiangsu Province Hospital
Nanjing, Jiangsu, China
Nanjing Drum Tower Hospital
Nanjing, Jiangsu, China
Affiliated Hospital of Nantong University
Nantong, Jiangsu, China
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China
The Second Hospital of Dalian Medical University
Dalian, Liaoning, China
The First Hospital of China Medical University
Shenyang, Liaoning, China
Cancer hospital of Dalian university of technology
Shenyang, Liaoning, China
China shenyang the tenth People's Hospital
Shenyang, Liaoning, China
Jinan Central Hospital
Jinan, Shandong, China
Linyi Cancer Hospital
Linyi, Shandong, China
The Affiliated Hospital of Qingdao University
Qingdao, Shandong, China
Weifang People's Hospital
Weifang, Shandong, China
Shanghai Geriatric Medical Center
Shanghai, Shanghai Municipality, China
Shanghai Chest Hospital
Shanghai, Shanghai Municipality, China
Shanghai Pulmonary Hospital
Shanghai, Shanghai Municipality, China
Shanxi Cancer Hospital
Taiyuan, Shanxi, China
Sichuan Cancer Hospital
Chengdu, Sichuan, China
West China Hospital of Sichuan University
Chengdu, Sichuan, China
Yibin Second People's Hospital
Yibin, Sichuan, China
Tianjin Chest Hospital
Tianjin, Tianjin Municipality, China
Tianjin Medical University Cancer Institute & Hospital
Tianjin, Tianjin Municipality, China
Yunnan Cancer Hospital
Kunming, Yunnan, China
The First Affiliated Hospital,Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China
Hospices Civil de Lyon
Bron, Auvergne-Rhône-Alpes, France
Hospital Nord de Marseille
Marseille, Bouches-du-Rhone, France
Centre Francois Baclesse
Caen, Calvados, France
Hopital Larrey
Toulouse, Occitanie, France
Centre Leon-Berard
Lyon, France
Hopital Nord Guilaume-et-Rene-Laennec CHU de Nantes
Saint-Herblain, France
Insitut de Canderologie d I'Ouest
Saint-Herblain, France
Henry Dunant Hospital Center
Athens, Greece
University General Hospital Attikon - General Hospital of West Attica H AGIA VARVARA
Athens, Greece
Athens Medical Center S.A., European Interbalkan Medical Center
Thessaloniki, Greece
Thoracic General Hospital of Athens I Sotiria
Thessaloniki, Greece
Queen Mary Hospital
Hong Kong, Hong Kong, Hong Kong
Prince of Wales Hospital
Shatin, New Territories, Hong Kong
Humanity and Health Clinical Trial Centre
Central, 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
Fujita Health University Hospital
Toyoake, Aichi-ken, Japan
National Cancer Center Hospital East
Kashiwa, Chiba, Japan
Kurume University Hospital
Kurume-Shi, Fukuoka, Japan