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

⚠️

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)
July 2, 2026
Sex
No restrictions

Therapies / drugs in trial

Locations (78)

USC/Norris Comprehensive Cancer Center

Los Angeles, 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

Northwell Health/R.J. Zuckerberg Cancer Center

Lake Success, United States

Laura & Isaac Perlmutter Cancer Center at NYU Langone Health

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

BC Cancer Vancouver Centre

Vancouver, Canada

The Ottawa Hospital Cancer Centre

Ottawa, Canada

Sunnybrook Research Institute

Toronto, Canada

Princess Margaret Cancer Centre - University Health Network

Toronto, Canada

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

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

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

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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