Global, Phase 3, randomized, multicenter, open-label study evaluating the efficacy andsafety of firmonertinib at a dose level of 240 mg QD compared to investigator's choice ofosimertinib (80 mg QD) or afatinib (40 mg QD) in participants who have locally advancedor metastatic NSCLC with EGFR PACC mutations, and who have not received any prior therapyfor advanced disease. Participants will be randomized in a 1:1 ratio to treatment withfirmonertinib or osimertinib or afatinib and will take the assigned dose daily.
Not Provided
Drug: Firmonertinib
240 mg oral, daily firmonertinib tablet
Other Name: AST2818
Drug: EGFR-TKI inhibitor based on investigator's choice
osimertinib 80 mg oral, daily tablet OR afatinib 40 mg oral, daily tablet
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.
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
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
Vanessa Esquibel
619-540-3451
FURMO006CT@arrivent.com
Morgan Lam, Study Director
ArriVent BioPharm