RecruitingPhase IIIEN originalLung cancerMetastatic / advanced

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

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This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.

About the trial

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.

Original English text from ClinicalTrials.gov

Who can (and can't) join

✓ Qualifies

  • •Rak płuca (typ niedrobnokomórkowy) w zaawansowanym stadium lub z przerzutami, który nie nadaje się do operacji ani radioterapii leczniczej.
  • •Potwierdzona w badaniu guza lub krwi obecność specyficznej rzadkiej mutacji EGFR (PACC).
  • •Brak wcześniejszego leczenia systemowego (np. chemioterapia, immunoterapia) z powodu zaawansowanego raka płuca.
  • •Dopuszczalni są pacjenci z przerzutami do mózgu, którzy nie mają objawów.

✗ Disqualifies

  • •Pacjenci, którzy wcześniej otrzymali leczenie celowane na EGFR (np. inne inhibitory kinazy tyrozynowej).

Simplified criteria — AI translation

Trial details

Minimum age
18 Years
Last updated (source)
October 14, 2026
Sex
No restrictions

Therapies / drugs in trial

Locations (139)

St. Jude Medical Center

Fullerton, United States

USC/Norris Comprehensive Cancer Center

Los Angeles, United States

Providence St. Joseph Hospital

Orange, United States

University of California Davis Comprehensive Cancer Center

Sacramento, United States

UCSF Medical Center-Mission Bay

San Francisco, United States

Kaiser Permanente Medical Center

Vallejo, United States

University of Colorado Health

Aurora, United States

Illinois Cancer Specialists

Arlington Heights, United States

University of Illinois Hospital and Health Sciences Systems

Chicago, United States

Henry Ford Cancer Institute

Detroit, United States

Northwell Health/R.J. Zuckerberg Cancer Center

Lake Success, United States

Laura & Isaac Perlmutter Cancer Center at NYU Langone Health

New York, United States

Columbia University Medical Center

New York, United States

Ohio State University Hospitals

Columbus, United States

Fox Chase Cancer Center

Philadelphia, United States

Texas Oncology

Dallas, United States

The University of Texas MD Anderson Cancer Center

Houston, United States

University of Virginia

Charlottesville, United States

Virginia Cancer Specialists

Fairfax, United States

Shenandoah Oncology, P.C.

Winchester, United States

Swedish Cancer Institute

Edmonds, United States

Blacktown Cancer and Haematology Centre

Blacktown, Australia

Chris O'Brien Lifehouse

Camperdown, Australia

GenesisCare North Shore Health Hub

St Leonards, Australia

Austin Health

Heidelberg, Australia

Alberta Health Services, Tom Baker Cancer Centre

Calgary, Canada

University of Alberta - Cross Cancer Institute (CCI)

Edmonton, Canada

BC Cancer Vancouver Centre

Vancouver, Canada

Brampton Civic Hospital, William Osler Health Centre

Brampton, Canada

The Ottawa Hospital Cancer Centre

Ottawa, Canada

Sunnybrook Research Institute

Toronto, Canada

Princess Margaret Cancer Centre - University Health Network

Toronto, Canada

Anhui Provincial Hospital

Hefei, China

Peking University People's Hospital

Beijing, China

Peking University Cancer Hospital (PKUCH)/Beijing Cancer Hospital

Beijing, China

Beijing Chest Hospital, Capital Medical University

Beijing, China

The First Affiliated Hospital of Chongqing Medical University

Chongqing, China

Fujian Cancer Hospital

Fuzhou, China

Zhongshan Hospital Xiamen University

Xiamen, China

The First People's Hospital of Foshan

Foshan, China

The First Affiliated Hospital, Sun Yat-sen University

Guangzhou, China

Nanfang Hospital, Southern Medical University

Guangzhou, China

Cancer Hospital of Shantou University Medical College

Shantou, China

Guangxi Medical University Cancer Hospital

Nanning, China

The Fourth Hospital of Hebei Medical University

Shijiazhuang, China

Harbin Medical University Cancer Hospital

Harbin, China

The First Affiliated Hospital of Henan University of Science & Technology

Luoyang, China

The First Affiliated Hospital of Henan Medical University

Xinxiang, China

Henan Cancer Center

Zhengzhou, China

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, China

Union Hospital Tongji Medical College Huazhong University Of Science And Technology

Wuhan, China

Xiangya Hospital of Central South University

Changsha, China

Hunan Cancer Hospital

Changsha, China

Profile of The Third Xiangya Hospital of Central South University

Changsha, China

The Affiliated Hospital of Inner Mongolia Medical University

Hohhot, China

Jiangsu Province Hospital

Nanjing, China

Nanjing Drum Tower Hospital

Nanjing, China

Affiliated Hospital of Nantong University

Nantong, China

The First Affiliated Hospital of Nanchang University

Nanchang, China

The First Hospital of China Medical University

Shenyang, China

Cancer hospital of Dalian university of technology

Shenyang, China

China shenyang the tenth People's Hospital

Shenyang, China

Jinan Central Hospital

Jinan, China

Linyi Cancer Hospital

Linyi, China

The Affiliated Hospital of Qingdao University

Qingdao, China

Weifang People's Hospital

Weifang, China

Shanghai Geriatric Medical Center

Shanghai, China

Shanghai Chest Hospital

Shanghai, China

Shanghai Pulmonary Hospital

Shanghai, China

Shanxi Cancer Hospital

Taiyuan, China

Sichuan Cancer Hospital

Chengdu, China

West China Hospital of Sichuan University

Chengdu, China

Yibin Second People's Hospital

Yibin, China

Tianjin Chest Hospital

Tianjin, China

Tianjin Medical University Cancer Institute & Hospital

Tianjin, China

Yunnan Cancer Hospital

Kunming, China

The First Affiliated Hospital,Zhejiang University School of Medicine

Hangzhou, China

Zhejiang Cancer Hospital

Hangzhou, China

Hospices Civil de Lyon

Bron, France

Hospital Nord de Marseille

Marseille, France

Centre Francois Baclesse

Caen, France

Hopital Larrey

Toulouse, 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

Prince of Wales Hospital

Shatin, 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, Japan

Fujita Health University Hospital

Toyoake, Japan

National Cancer Center Hospital East

Kashiwa, Japan

Kurume University Hospital

Kurume-Shi, Japan

National Hospital Organization Hokkaido Cancer Center

Sapporo, Japan

Hyogo Cancer Center

Akashi-shi, Japan

Miyagi Cancer Center

Natori-shi, Japan

Niigata Cancer Center Hospital

Niigata, Japan

Kansai Medical University Hospital

Hirakata-shi, Japan

Nippon Medical School Hospital

Bunkyo-ku, Japan

Tokyo Metropolitan Komagome Hospital

Bunkyō-Ku, Japan

National Cancer Center Hospital

Chuo-ku, Japan

OncoCar Cancer Centre

Petaling Jaya, Malaysia

Hospital Kuala Lumpur

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, South Korea

Chonnam National University Hwasun Hospital

Hwasun, 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, 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, Thailand

Chulabhorn Hospital

Lak Si, Thailand

Prince of Songkla Hospital

Hat Yai, Thailand

Faculty of Medicine Vajira Hospital, Navamindradhiraj University

Bangkok, Thailand

Memorial Ankara Hospital

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, United Kingdom

The Christie NHS Foundation Trust

Manchester, United Kingdom

The Royal Marsden NHS Foundation Trust

London, United Kingdom

Trial contact

Contact information from ClinicalTrials.gov. Contact in English.

Share this trial

Data from ClinicalTrials.gov. AI-assisted translation, last sync: 7/3/2026.

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