RecruitingRecruiting
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
NCT07185997 · ArriVent BioPharma, Inc.
In plain English
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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)
About this study
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
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.
Study design
Enrollment target: 480 participants
Allocation: randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2025-12-17
Estimated completion: 2030-12
Last updated: 2026-05-11
Interventions
Drug: FirmonertinibDrug: EGFR-TKI inhibitor based on investigator's choice
Primary outcomes
- • Progression Free Survival (PFS) determined by blinded independent central review (BICR) (Until progression or death, assessed up to approximately 4 years)
- • Confirmed overall response rate (ORR) as determined by BICR (Until progression or death, assessed up to approximately 3 years)
Sponsor
ArriVent BioPharma, Inc. · industry
Contacts & investigators
ContactVanessa Esquibel · contact · FURMO006CT@arrivent.com · 619-540-3451
InvestigatorMorgan Lam · study_director, ArriVent BioPharm
All locations (62)
USC/Norris Comprehensive Cancer CenterRecruiting
Los Angeles, California, United States
University of California Davis Comprehensive Cancer CenterRecruiting
Sacramento, California, United States
UCSF Medical Center-Mission BayRecruiting
San Francisco, California, United States
Kaiser Permanente Medical CenterRecruiting
Vallejo, California, United States
Illinois Cancer SpecialistsRecruiting
Arlington Heights, Illinois, United States
University of Illinois Hospital and Health Sciences SystemsRecruiting
Chicago, Illinois, United States
Northwell Health/R.J. Zuckerberg Cancer CenterRecruiting
Lake Success, New York, United States
Laura & Isaac Perlmutter Cancer Center at NYU Langone HealthRecruiting
New York, New York, United States
Ohio State University HospitalsRecruiting
Columbus, Ohio, United States
Fox Chase Cancer CenterRecruiting
Philadelphia, Pennsylvania, United States
Texas OncologyRecruiting
Dallas, Texas, United States
The University of Texas MD Anderson Cancer CenterRecruiting
Houston, Texas, United States
University of VirginiaRecruiting
Charlottesville, Virginia, United States
Virginia Cancer SpecialistsRecruiting
Fairfax, Virginia, United States
Shenandoah Oncology, P.C.Recruiting
Winchester, Virginia, United States
Blacktown Cancer and Haematology CentreRecruiting
Blacktown, New South Wales, Australia
Chris O'Brien LifehouseRecruiting
Camperdown, New South Wales, Australia
GenesisCare North Shore Health HubRecruiting
St Leonards, New South Wales, Australia
Austin HealthRecruiting
Heidelberg, Victoria, Australia
BC Cancer Vancouver CentreRecruiting
Vancouver, British Columbia, Canada
The Ottawa Hospital Cancer CentreRecruiting
Ottawa, Ontario, Canada
Sunnybrook Research InstituteRecruiting
Toronto, Ontario, Canada
Princess Margaret Cancer Centre - University Health NetworkRecruiting
Toronto, Ontario, Canada
Henry Dunant Hospital CenterRecruiting
Athens, Greece
University General Hospital Attikon - General Hospital of West Attica H AGIA VARVARARecruiting
Athens, Greece
Athens Medical Center S.A., European Interbalkan Medical CenterRecruiting
Thessaloniki, Greece
Thoracic General Hospital of Athens I SotiriaRecruiting
Thessaloniki, Greece
Humanity and Health Clinical Trial CentreRecruiting
Central, Hong Kong
Queen Mary HospitalRecruiting
Hong Kong, Hong Kong
SOC Oncologia Medica e dei Tumori Immuno-correlatiRecruiting
Aviano, Italy
Istituto Europeo di Oncologia (IEO)Recruiting
Milan, Italy
Aichi Cancer CenterRecruiting
Nagoya, Aichi-ken, Japan
Kurume University HospitalRecruiting
Kurume-Shi, Fukuoka, Japan
National Hospital Organization Hokkaido Cancer CenterRecruiting
Sapporo, Hokkaido, Japan
Hyogo Cancer CenterRecruiting
Akashi-shi, Hyōgo, Japan
Miyagi Cancer CenterRecruiting
Natori-shi, Miyagi, Japan
Niigata Cancer Center HospitalRecruiting
Niigata, Niigata, Japan
Kansai Medical University HospitalRecruiting
Hirakata-shi, Osaka, Japan
Nippon Medical School HospitalRecruiting
Bunkyo-ku, Tokyo, Japan
Tokyo Metropolitan Komagome HospitalRecruiting
Bunkyō-Ku, Tokyo, Japan
National Cancer Center HospitalRecruiting
Chuo-ku, Tokyo, Japan
Hospital Kuala LumpurRecruiting
Kuala Lumpur, WP Kuala Lumpur, Malaysia
National Cancer Centre SingaporeRecruiting
Singapore, Singapore
Curie Oncology (Farrer)Recruiting
Singapore, Singapore
Tan Tok Seng HospitalRecruiting
Singapore, Singapore
The Catholic University of Korea, St. Vincent's HospitalRecruiting
Suwon, Gyeonggi-do, South Korea
Chonnam National University Hwasun HospitalRecruiting
Hwasun, Jeollanam-do, South Korea
Gachon University Gil Medical CenterRecruiting
Incheon, South Korea
Kangbuk Samsung HospitalRecruiting
Seoul, South Korea
Asan Medical CenterRecruiting
Seoul, South Korea
Samsung Medical CenterRecruiting
Seoul, South Korea
Hospital Universitari Son EspasesRecruiting
Palma, Balearic Islands, Spain
Hospital Clinic de BarcelonaRecruiting
Barcelona, Spain
Hospital QuironSalud MalagaRecruiting
Málaga, Spain
Hospital Universitario Central de AsturiasRecruiting
Oviedo, Spain
Hospital Universitario y Politecnico La FeRecruiting
Valencia, Spain
Kaohsiung Medical University Chung-Ho Memorial HospitalRecruiting
Kaohsiung City, Taiwan
Taichung Veterans General HospitalRecruiting
Taichung, Taiwan
Taipei Veterans General HospitalRecruiting
Taipei, Taiwan
University College London Hospitals NHS Foundation TrustRecruiting
London, England, United Kingdom
The Christie NHS Foundation TrustRecruiting
Manchester, England, United Kingdom
The Royal Marsden NHS Foundation TrustRecruiting
London, United Kingdom