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RECRUITING Phase 3 ClinicalTrials.gov

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. • ClinicalTrials.gov ID: NCT07185997

Registry updated: 2026-10-14
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Description

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.

Interventions

  • Firmonertinib (Drug)
    240 mg oral, daily firmonertinib tablet
  • EGFR-TKI inhibitor based on investigator's choice (Drug)
    osimertinib 80 mg oral, daily tablet OR afatinib 40 mg oral, daily tablet

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. * List of eligible PACC mutations: E709X, E709A, E709H, E709V, E709K E709\_T710delinsD, E709\_T710delinsA, E709\_T710delinsG, L718M, L718P, L718Q, L718V, G719X, G719A, G719C, G719D, G719S, G724S, E736K, I740\_K745dup, I740\_K745dupIPVAIK, I744\_K745insKIPVAI, L747P, L747S, K757M, K757R, V765L, S768I, S768\_V769delinsIL, S768\_V769delinsIM, S768\_V769delinsPL, V769L, V769M, N771G, H773\_V774delinsLM, V774M, R776C, R776H, G779F, L792H, G796S, T854A, T854S, T854I, A647T, R675W, S768C, A755D, A750\_I759delinsPN, T751\_I759delinsN

Conditions

Non-Small-Cell Lung Cancer Metastatic Non-Small-Cell Lung Cancer Advanced Non-Small-Cell Lung Cancer EGFR P-Loop and Alpha C-Helix Compressing EGFR PACC EGFR Uncommon Mutations

Locations

  • 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
  • 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 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
  • 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
  • OncoCar Cancer Centre — Petaling Jaya, Selangor, Malaysia
  • 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
  • Kyung Hee University Hospital — Seoul, 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 Central de Asturias — Oviedo, 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
  • National Taiwan University Cancer Center — Taipei, Taiwan
  • Taipei Veterans General Hospital — Taipei, Taiwan
  • Mahidol University - Siriraj Hospital — Bangkoknoi, Bangkok, Thailand
  • Chulabhorn Hospital — Lak Si, Bangkok, Thailand
  • Prince of Songkla Hospital — Hat Yai, Changwat Songkhla, Thailand
  • Faculty of Medicine Vajira Hospital, Navamindradhiraj University — Bangkok, Thailand
  • Memorial Ankara Hospital — Ankara, Ankara, Turkey (Türkiye)
  • Gulhane Training and Research Hospital — Ankara, Turkey (Türkiye)
  • Anatalya Province — Antalya, Turkey (Türkiye)
  • Medical Park Florya Hospital — Istanbul, Turkey (Türkiye)
  • Istinye University Bahcesehir Liv Hospital — Istanbul, Turkey (Türkiye)
  • 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
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record