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)
Status: Recruiting
Location: See all (118) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
⁃ Key Eligibility Criteria:
• Histologically or cytologically documented, locally advanced or metastatic Non-Small Cell Lung Cancer (NSCLC) not amenable to curative surgery or radiotherapy.
• Documented results of the presence of an Epidermal Growth Factor Receptor (EGFR) PACC mutation in tumor tissue or blood from local testing.
• No prior systemic anticancer therapy regimens received for locally advanced or metastatic Non-Small Cell Lung Cancer (NSCLC) including prior treatment with any Epidermal Growth Factor Receptor (EGFR)-targeting agents (e.g., previous (EGFR) TKIs, monoclonal antibodies, or bispecific antibodies).
• Patients who have received prior neo-adjuvant and/or adjuvant chemotherapy, immunotherapy, or chemo radiotherapy for non-metastatic disease must have experienced a treatment free interval of at least 12 months.
• Patients with asymptomatic CNS metastases are eligible.
Locations
United States
California
St. Jude Medical Center
RECRUITING
Fullerton
USC/Norris Comprehensive Cancer Center
RECRUITING
Los Angeles
Providence St. Joseph Hospital
RECRUITING
Orange
University of California Davis Comprehensive Cancer Center
RECRUITING
Sacramento
UCSF Medical Center-Mission Bay
RECRUITING
San Francisco
Kaiser Permanente Medical Center
RECRUITING
Vallejo
Colorado
University of Colorado Health
RECRUITING
Aurora
Illinois
Illinois Cancer Specialists
RECRUITING
Arlington Heights
University of Illinois Hospital and Health Sciences Systems
RECRUITING
Chicago
Michigan
Henry Ford Cancer Institute
RECRUITING
Detroit
New York
Northwell Health/R.J. Zuckerberg Cancer Center
RECRUITING
Lake Success
Laura & Isaac Perlmutter Cancer Center at NYU Langone Health
RECRUITING
New York
Ohio
Ohio State University Hospitals
RECRUITING
Columbus
Pennsylvania
Fox Chase Cancer Center
RECRUITING
Philadelphia
Texas
Texas Oncology
RECRUITING
Dallas
The University of Texas MD Anderson Cancer Center
RECRUITING
Houston
Virginia
University of Virginia
RECRUITING
Charlottesville
Virginia Cancer Specialists
RECRUITING
Fairfax
Shenandoah Oncology, P.C.
RECRUITING
Winchester
Washington
Swedish Cancer Institute
RECRUITING
Edmonds
Other Locations
Australia
Blacktown Cancer and Haematology Centre
RECRUITING
Blacktown
Chris O'Brien Lifehouse
RECRUITING
Camperdown
Austin Health
RECRUITING
Heidelberg
GenesisCare North Shore Health Hub
RECRUITING
St Leonards
Canada
Brampton Civic Hospital, William Osler Health Centre
RECRUITING
Brampton
Alberta Health Services, Tom Baker Cancer Centre
RECRUITING
Calgary
The Ottawa Hospital Cancer Centre
RECRUITING
Ottawa
Princess Margaret Cancer Centre - University Health Network
RECRUITING
Toronto
Sunnybrook Research Institute
RECRUITING
Toronto
BC Cancer Vancouver Centre
RECRUITING
Vancouver
China
Beijing Chest Hospital, Capital Medical University
RECRUITING
Beijing
Peking University People's Hospital
RECRUITING
Beijing
Profile of The Third Xiangya Hospital of Central South University
RECRUITING
Changsha
Sichuan Cancer Hospital
RECRUITING
Chengdu
The First People's Hospital of Foshan
RECRUITING
Foshan
Zhejiang Cancer Hospital
RECRUITING
Hangzhou
Harbin Medical University Cancer Hospital
RECRUITING
Harbin
The Affiliated Hospital of Inner Mongolia Medical University
RECRUITING
Hohhot
Yunnan Cancer Hospital
RECRUITING
Kunming
The First Affiliated Hospital of Henan University of Science & Technology
RECRUITING
Luoyang
The First Affiliated Hospital of Nanchang University
RECRUITING
Nanchang
Jiangsu Province Hospital
RECRUITING
Nanjing
Nanjing Drum Tower Hospital
RECRUITING
Nanjing
Affiliated Hospital of Nantong University
RECRUITING
Nantong
The Affiliated Hospital of Qingdao University
RECRUITING
Qingdao
Shanghai Chest Hospital
RECRUITING
Shanghai
Cancer Hospital of Shantou University Medical College
RECRUITING
Shantou
China shenyang the tenth People's Hospital
RECRUITING
Shenyang
The Fourth Hospital of Hebei Medical University
RECRUITING
Shijiazhuang
Shanxi Cancer Hospital
RECRUITING
Taiyuan
Tianjin Chest Hospital
RECRUITING
Tianjin
Tianjin Medical University Cancer Institute & Hospital
RECRUITING
Tianjin
Weifang People's Hospital
RECRUITING
Weifang
Union Hospital Tongji Medical College Huazhong University Of Science And Technology
RECRUITING
Wuhan
Zhongshan Hospital Xiamen University
RECRUITING
Xiamen
The First Affiliated Hospital of Henan Medical University
RECRUITING
Xinxiang
The First Affiliated Hospital of Zhengzhou University
RECRUITING
Zhengzhou
France
Hospices Civil de Lyon
RECRUITING
Bron
Centre Francois Baclesse
RECRUITING
Caen
Centre Leon-Berard
RECRUITING
Lyon
Hospital Nord de Marseille
RECRUITING
Marseille
Hopital Nord Guilaume-et-Rene-Laennec CHU de Nantes
RECRUITING
Saint-herblain
Insitut de Canderologie d I'Ouest
RECRUITING
Saint-herblain
Hopital Larrey
RECRUITING
Toulouse
Greece
Henry Dunant Hospital Center
RECRUITING
Athens
University General Hospital Attikon - General Hospital of West Attica H AGIA VARVARA
RECRUITING
Athens
Athens Medical Center S.A., European Interbalkan Medical Center
RECRUITING
Thessaloniki
Thoracic General Hospital of Athens I Sotiria
RECRUITING
Thessaloniki
Hong Kong Special Administrative Region
Humanity and Health Clinical Trial Centre
RECRUITING
Central
Queen Mary Hospital
RECRUITING
Hong Kong
Prince of Wales Hospital
RECRUITING
Shatin
Italy
SOC Oncologia Medica e dei Tumori Immuno-correlati
RECRUITING
Aviano
Istituto Europeo di Oncologia (IEO)
RECRUITING
Milan
Japan
Hyogo Cancer Center
RECRUITING
Akashi-shi
Nippon Medical School Hospital
RECRUITING
Bunkyo-ku
Tokyo Metropolitan Komagome Hospital
RECRUITING
Bunkyō-ku
National Cancer Center Hospital
RECRUITING
Chuo-ku
Kansai Medical University Hospital
RECRUITING
Hirakata-shi
National Cancer Center Hospital East
RECRUITING
Kashiwa
Kurume University Hospital
RECRUITING
Kurume-shi
Aichi Cancer Center
RECRUITING
Nagoya
Miyagi Cancer Center
RECRUITING
Natori-shi
Niigata Cancer Center Hospital
RECRUITING
Niigata
National Hospital Organization Hokkaido Cancer Center
RECRUITING
Sapporo
Fujita Health University Hospital
RECRUITING
Toyoake
Malaysia
Hospital Kuala Lumpur
RECRUITING
Kuala Lumpur
OncoCar Cancer Centre
RECRUITING
Petaling Jaya
Republic of Korea
Chonnam National University Hwasun Hospital
RECRUITING
Hwasun
Gachon University Gil Medical Center
RECRUITING
Incheon
Asan Medical Center
RECRUITING
Seoul
Kangbuk Samsung Hospital
RECRUITING
Seoul
Kyung Hee University Hospital
RECRUITING
Seoul
Samsung Medical Center
RECRUITING
Seoul
The Catholic University of Korea, St. Vincent's Hospital
RECRUITING
Suwon
Singapore
Curie Oncology (Farrer)
RECRUITING
Singapore
National Cancer Centre Singapore
RECRUITING
Singapore
Tan Tok Seng Hospital
RECRUITING
Singapore
Spain
Hospital Clinic de Barcelona
RECRUITING
Barcelona
Hospital QuironSalud Malaga
RECRUITING
Málaga
Hospital Universitario Central de Asturias
RECRUITING
Oviedo
Hospital Universitari Son Espases
RECRUITING
Palma
Hospital Universitario y Politecnico La Fe
RECRUITING
Valencia
Taiwan
Kaohsiung Medical University Chung-Ho Memorial Hospital
RECRUITING
Kaohsiung City
Taichung Veterans General Hospital
RECRUITING
Taichung
National Taiwan University Cancer Center
RECRUITING
Taipei
Taipei Veterans General Hospital
RECRUITING
Taipei
Thailand
Faculty of Medicine Vajira Hospital, Navamindradhiraj University
RECRUITING
Bangkok
Mahidol University - Siriraj Hospital
RECRUITING
Bangkoknoi
Prince of Songkla Hospital
RECRUITING
Hat Yai
Chulabhorn Hospital
RECRUITING
Lak Si
Turkey
Gulhane Training and Research Hospital
RECRUITING
Ankara
Memorial Ankara Hospital
RECRUITING
Ankara
Anatalya Province
RECRUITING
Antalya
Istinye University Bahcesehir Liv Hospital
RECRUITING
Istanbul
Medical Park Florya Hospital
RECRUITING
Istanbul
United Kingdom
The Royal Marsden NHS Foundation Trust
RECRUITING
London
University College London Hospitals NHS Foundation Trust
RECRUITING
London
The Christie NHS Foundation Trust
RECRUITING
Manchester
Contact Information
Primary
Clinical Trials
FURMO006CT@arrivent.com
(888) 622-2827
Time Frame
Start Date: 2025-12-17
Estimated Completion Date: 2030-12
Participants
Target number of participants: 480
Treatments
Experimental: Firmonertinib 240 mg
Active_comparator: EGFR-TKI inhibitor osimertinib or afatinib based on investigator's choice
Related Therapeutic Areas
Sponsors
Leads: ArriVent BioPharma, Inc.