NCT07185997RecruitingPhase 3
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
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)
Source: ClinicalTrials.gov · Last updated 2 Nov 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 480 (estimated)
- First submitted
- 15 Aug 2025
- Start date
- 17 Dec 2025
- Primary completion date
- 28 Feb 2029
- Lead sponsor
- ArriVent BioPharma, Inc.
- Diseases
- Lung cancer
- NCT number
- NCT07185997
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 480
- From 17 Dec 2025 to the primary completion date, 28 Feb 2029
- 141 sites in 17 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Criteria the registry did not label
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (141)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Blacktown Cancer and Haematology Centre Coordinator of this site? Confirm its status | Blacktown | Australia | Recruiting |
| Chris O'Brien Lifehouse Coordinator of this site? Confirm its status | Camperdown | Australia | Recruiting |
| Austin Health Coordinator of this site? Confirm its status | Heidelberg | Australia | Recruiting |
| GenesisCare North Shore Health Hub Coordinator of this site? Confirm its status | St Leonards | Australia | Recruiting |
| Brampton Civic Hospital, William Osler Health Centre Coordinator of this site? Confirm its status | Brampton | Canada | Recruiting |
| Alberta Health Services, Tom Baker Cancer Centre Coordinator of this site? Confirm its status | Calgary | Canada | Recruiting |
| University of Alberta - Cross Cancer Institute (CCI) Coordinator of this site? Confirm its status | Edmonton | Canada | Recruiting |
| The Ottawa Hospital Cancer Centre Coordinator of this site? Confirm its status | Ottawa | Canada | Recruiting |
| Princess Margaret Cancer Centre - University Health Network Coordinator of this site? Confirm its status | Toronto | Canada | Recruiting |
| Sunnybrook Research Institute Coordinator of this site? Confirm its status | Toronto | Canada | Recruiting |
| BC Cancer Vancouver Centre Coordinator of this site? Confirm its status | Vancouver | Canada | Recruiting |
| Peking University People's Hospital Coordinator of this site? Confirm its status | Beijing | China | Recruiting |
| Cancer Hospital, Chinese Academy of Medical Sciences Coordinator of this site? Confirm its status | Beijing | China | Recruiting |
| Beijing chest hospital, Capital Medical University Coordinator of this site? Confirm its status | Beijing | China | Recruiting |
| Peking University Cancer Hospital (PKUCH)/Beijing Cancer Hospital Coordinator of this site? Confirm its status | Beijing | China | Recruiting |
| Hunan Cancer Hospital Coordinator of this site? Confirm its status | Changsha | China | Recruiting |
| Xiangya Hospital of Central South University Coordinator of this site? Confirm its status | Changsha | China | Recruiting |
| Profile of The Third Xiangya Hospital of Central South University Coordinator of this site? Confirm its status | Changsha | China | Recruiting |
| Sichuan Cancer Hospital Coordinator of this site? Confirm its status | Chengdu | China | Recruiting |
| West China Hospital of Sichuan University Coordinator of this site? Confirm its status | Chengdu | China | Recruiting |
| The First Affiliated Hospital of Chongqing Medical University Coordinator of this site? Confirm its status | Chongqing | China | Recruiting |
| The Second Hospital of Dalian Medical University Coordinator of this site? Confirm its status | Dalian | China | Recruiting |
| The First People's Hospital of Foshan Coordinator of this site? Confirm its status | Foshan | China | Recruiting |
| Fujian Cancer Hospital Coordinator of this site? Confirm its status | Fuzhou | China | Recruiting |
| Nanfang Hospital, Southern Medical University Coordinator of this site? Confirm its status | Guangzhou | China | Recruiting |
| The First Affiliated Hospital, Sun Yat-sen University Coordinator of this site? Confirm its status | Guangzhou | China | Recruiting |
| Zhejiang Cancer Hospital Coordinator of this site? Confirm its status | Hangzhou | China | Recruiting |
| The First Affiliated Hospital Zhejiang University School of Medicine Coordinator of this site? Confirm its status | Hangzhou | China | Recruiting |
| Harbin Medical University Cancer Hospital Coordinator of this site? Confirm its status | Harbin | China | Recruiting |
| Anhui Provincial Hospital Coordinator of this site? Confirm its status | Hefei | China | Recruiting |
| The Affiliated Hospital of Inner Mongolia Medical University Coordinator of this site? Confirm its status | Hohhot | China | Recruiting |
| Jinan Central Hospital Coordinator of this site? Confirm its status | Jinan | China | Recruiting |
| Yunnan Cancer Hospital Coordinator of this site? Confirm its status | Kunming | China | Recruiting |
| LinYi Cancer Hospital Coordinator of this site? Confirm its status | Linyi | China | Recruiting |
| The First Affiliated Hospital of Henan University of Science &Technology Coordinator of this site? Confirm its status | Luoyang | China | Recruiting |
| The First Affiliated Hospital of NanChang University Coordinator of this site? Confirm its status | Nanchang | China | Recruiting |
| Jiangsu Province Hospital Coordinator of this site? Confirm its status | Nanjing | China | Recruiting |
| Nanjing Drum Tower hospital Coordinator of this site? Confirm its status | Nanjing | China | Recruiting |
| Guangxi Medical University Cancer Hospital Coordinator of this site? Confirm its status | Nanning | China | Recruiting |
| Affiliated Hospital of Nantong University Coordinator of this site? Confirm its status | Nantong | China | Recruiting |
| The Affiliated Hospital of Qingdao University Coordinator of this site? Confirm its status | Qingdao | China | Recruiting |
| Shanghai Geriatric Medical Center Coordinator of this site? Confirm its status | Shanghai | China | Recruiting |
| Shanghai Pulmonary Hospital Coordinator of this site? Confirm its status | Shanghai | China | Recruiting |
| Shanghai Chest Hospital Coordinator of this site? Confirm its status | Shanghai | China | Recruiting |
| Cancer Hospital of Shantou University Medical College Coordinator of this site? Confirm its status | Shantou | China | Recruiting |
| China shenyang the tenth People's Hospital Coordinator of this site? Confirm its status | Shenyang | China | Recruiting |
| Cancer hospital of Dalian university of technology Coordinator of this site? Confirm its status | Shenyang | China | Recruiting |
| The First Hospital of China Medical University Coordinator of this site? Confirm its status | Shenyang | China | Recruiting |
| The Fourth Hospital of Hebei Medical University Coordinator of this site? Confirm its status | Shijiazhuang | China | Recruiting |
| Shanxi Cancer hospital Coordinator of this site? Confirm its status | Taiyuan | China | Recruiting |
| Tianjin Medical University Cancer Institute & Hospital Coordinator of this site? Confirm its status | Tianjin | China | Recruiting |
| Tianjin Chest Hospital Coordinator of this site? Confirm its status | Tianjin | China | Recruiting |
| Weifang People's Hospital Coordinator of this site? Confirm its status | Weifang | China | Recruiting |
| Union Hospital, Tongji Medical College, Huazhong University of Science and Technology Coordinator of this site? Confirm its status | Wuhan | China | Recruiting |
| Zhongshan Hospital Xiamen University Coordinator of this site? Confirm its status | Xiamen | China | Recruiting |
| The First Affiliated Hospital of Henan Medical University Coordinator of this site? Confirm its status | Xinxiang | China | Recruiting |
| Yibin Second People's Hospital Coordinator of this site? Confirm its status | Yibin | China | Recruiting |
| Henan Cancer Center Coordinator of this site? Confirm its status | Zhengzhou | China | Recruiting |
| The First Affiliated Hospital of Zhengzhou University Coordinator of this site? Confirm its status | Zhengzhou | China | Recruiting |
| Hospital Clinic de Barcelona Coordinator of this site? Confirm its status | Barcelona | Spain | Recruiting |
| Hospital Quironsalud Malaga Coordinator of this site? Confirm its status | Málaga | Spain | Recruiting |
| Hospital Universitario Central De Asturias Coordinator of this site? Confirm its status | Oviedo | Spain | Recruiting |
| Hospital Universitari Son Espases Coordinator of this site? Confirm its status | Palma | Spain | Recruiting |
| Hospital Universitario Y Politecnico La Fe Coordinator of this site? Confirm its status | Valencia | Spain | Recruiting |
| Hospices Civil de Lyon Coordinator of this site? Confirm its status | Bron | France | Recruiting |
| Centre François Baclesse Coordinator of this site? Confirm its status | Caen | France | Recruiting |
| Centre Leon Berard Coordinator of this site? Confirm its status | Lyon | France | Recruiting |
| Hospital Nord de Marseille Coordinator of this site? Confirm its status | Marseille | France | Recruiting |
| Hopital Nord Guilaume-et-Rene-Laennec CHU de Nantes Coordinator of this site? Confirm its status | Saint-Herblain | France | Recruiting |
| Insitut de Canderologie d I'Ouest Coordinator of this site? Confirm its status | Saint-Herblain | France | Recruiting |
| Hopital Larrey Coordinator of this site? Confirm its status | Toulouse | France | Recruiting |
| The Royal Marsden NHS Foundation Trust Coordinator of this site? Confirm its status | London | United Kingdom | Recruiting |
| University College London Hospitals NHS Foundation Trust Coordinator of this site? Confirm its status | London | United Kingdom | Recruiting |
| The Christie NHS Foundation Trust Coordinator of this site? Confirm its status | Manchester | United Kingdom | Recruiting |
| University General Hospital Attikon General Hospital Of West Attica H Agia Varvara Coordinator of this site? Confirm its status | Athens | Greece | Recruiting |
| Henry Dunant Hospital Center Coordinator of this site? Confirm its status | Athens | Greece | Recruiting |
| Thoracic General Hospital of Athens I Sotiria Coordinator of this site? Confirm its status | Thessaloniki | Greece | Recruiting |
| Athens Medical Center S.A., European Interbalkan Medical Center Coordinator of this site? Confirm its status | Thessaloniki | Greece | Recruiting |
| Humanity and Health Clinical Trial Centre Coordinator of this site? Confirm its status | Central | Hong Kong SAR China | Recruiting |
| Queen Mary Hospital Coordinator of this site? Confirm its status | Hong Kong | Hong Kong SAR China | Recruiting |
| Prince of Wales Hospital Coordinator of this site? Confirm its status | Shatin | Hong Kong SAR China | Recruiting |
| SOC Oncologia Medica e dei Tumori Immuno-correlati Coordinator of this site? Confirm its status | Aviano | Italy | Recruiting |
| Istituto Europeo di Oncologia (IEO) Coordinator of this site? Confirm its status | Milan | Italy | Recruiting |
| Hyogo Cancer Center Coordinator of this site? Confirm its status | Akashi-shi | Japan | Recruiting |
| Nippon Medical School Hospital Coordinator of this site? Confirm its status | Bunkyo-ku | Japan | Recruiting |
| Tokyo Metropolitan Komagome Hospital Coordinator of this site? Confirm its status | Bunkyo Ku | Japan | Recruiting |
| National Cancer Center Hospital Coordinator of this site? Confirm its status | Chuo Ku | Japan | Recruiting |
| Kansai Medical University Hospital Coordinator of this site? Confirm its status | Hirakata-shi | Japan | Recruiting |
| National Cancer Center Hospital East Coordinator of this site? Confirm its status | Kashiwa | Japan | Recruiting |
| Kurume University Hospital Coordinator of this site? Confirm its status | Kurume-shi | Japan | Recruiting |
| Aichi Cancer Center Coordinator of this site? Confirm its status | Nagoya | Japan | Recruiting |
| Miyagi Cancer Center Coordinator of this site? Confirm its status | Natori-shi | Japan | Recruiting |
| Niigata Cancer Center Hospital Coordinator of this site? Confirm its status | Niigata | Japan | Recruiting |
| National Hospital Organization Hokkaido Cancer Center Coordinator of this site? Confirm its status | Sapporo | Japan | Recruiting |
| Fujita Health University Hospital Coordinator of this site? Confirm its status | Toyoake | Japan | Recruiting |
| Chonnam National University Hwasun Hospital Coordinator of this site? Confirm its status | Hwasun | South Korea | Recruiting |
| Gachon University Gil Medical Center Coordinator of this site? Confirm its status | Incheon | South Korea | Recruiting |
| Kangbuk Samsung Hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Recruiting |
| Asan Medical Center Coordinator of this site? Confirm its status | Seoul | South Korea | Recruiting |
| Samsung Medical Center Coordinator of this site? Confirm its status | Seoul | South Korea | Recruiting |
| Kyung Hee University Hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Recruiting |
| The Catholic University of Korea St. Vincent's Hospital Coordinator of this site? Confirm its status | Suwon | South Korea | Recruiting |
| Hospital Kuala Lumpur Coordinator of this site? Confirm its status | Kuala Lumpur | Malaysia | Recruiting |
| OncoCar Cancer Centre Coordinator of this site? Confirm its status | Petaling Jaya | Malaysia | Recruiting |
| Curie Oncology (Farrer) Coordinator of this site? Confirm its status | Singapore | Singapore | Recruiting |
| Tan Tok Seng Hospital Coordinator of this site? Confirm its status | Singapore | Singapore | Recruiting |
| National Cancer Centre Singapore Coordinator of this site? Confirm its status | Singapore | Singapore | Recruiting |
| Faculty of Medicine Vajira Hospital, Navamindradhiraj University Coordinator of this site? Confirm its status | Bangkok | Thailand | Recruiting |
| Mahidol University - Siriraj Hospital Coordinator of this site? Confirm its status | Bangkoknoi | Thailand | Recruiting |
| Prince of Songkla Hospital Coordinator of this site? Confirm its status | Hat Yai | Thailand | Recruiting |
| Chulabhorn Hospital Coordinator of this site? Confirm its status | Lak Si | Thailand | Recruiting |
| Kaohsiung Medical University Chung-Ho Memorial Hospital Coordinator of this site? Confirm its status | Kaohsiung City | Taiwan | Recruiting |
| Taichung Veterans General Hospital Coordinator of this site? Confirm its status | Taichung | Taiwan | Recruiting |
| Taipei Veterans General Hospital Coordinator of this site? Confirm its status | Taipei | Taiwan | Recruiting |
| National Taiwan University Cancer Center Coordinator of this site? Confirm its status | Taipei | Taiwan | Recruiting |
| Illinois Cancer Specialists Coordinator of this site? Confirm its status | Arlington Heights | United States | Recruiting |
| University of Colorado Health Coordinator of this site? Confirm its status | Aurora | United States | Recruiting |
| University of Virginia Coordinator of this site? Confirm its status | Charlottesville | United States | Recruiting |
| University of Illinois Hospital and Health Sciences Systems Coordinator of this site? Confirm its status | Chicago | United States | Recruiting |
| Ohio State University Hospitals Coordinator of this site? Confirm its status | Columbus | United States | Recruiting |
| Texas Oncology Coordinator of this site? Confirm its status | Dallas | United States | Recruiting |
| Henry Ford Cancer Institute Coordinator of this site? Confirm its status | Detroit | United States | Recruiting |
| Swedish Cancer Institute Coordinator of this site? Confirm its status | Edmonds | United States | Recruiting |
| Virginia Cancer Specialists Coordinator of this site? Confirm its status | Fairfax | United States | Recruiting |
| St. Jude Medical Center Coordinator of this site? Confirm its status | Fullerton | United States | Recruiting |
| The University of Texas MD Anderson Cancer Center Coordinator of this site? Confirm its status | Houston | United States | Recruiting |
| Northwell Health/R.J. Zuckerberg Cancer Center Coordinator of this site? Confirm its status | Lake Success | United States | Recruiting |
| USC / Norris Comprehensive Cancer Center Coordinator of this site? Confirm its status | Los Angeles | United States | Recruiting |
| Laura & Isaac Perlmutter Cancer Center at NYU Langone Health Coordinator of this site? Confirm its status | New York | United States | Recruiting |
| Columbia University Medical Center Coordinator of this site? Confirm its status | New York | United States | Recruiting |
| Providence St. Joseph Hospital Coordinator of this site? Confirm its status | Orange | United States | Recruiting |
| Fox Chase Cancer Center Coordinator of this site? Confirm its status | Philadelphia | United States | Recruiting |
| University of California Davis Comprehensive Cancer Center Coordinator of this site? Confirm its status | Sacramento | United States | Recruiting |
| UCSF Medical Center-Mission Bay Coordinator of this site? Confirm its status | San Francisco | United States | Recruiting |
| Kaiser Permanente Medical Center Coordinator of this site? Confirm its status | Vallejo | United States | Recruiting |
| Shenandoah Oncology, P.C. Coordinator of this site? Confirm its status | Winchester | United States | Recruiting |
| Gulhane Training and Research Hospital Coordinator of this site? Confirm its status | Ankara | Turkey (Türkiye) | Recruiting |
| Memorial Ankara Hospital Coordinator of this site? Confirm its status | Ankara | Turkey (Türkiye) | Recruiting |
| Anatalya Province Coordinator of this site? Confirm its status | Antalya | Turkey (Türkiye) | Recruiting |
| Istinye University Bahcesehir Liv Hospital Coordinator of this site? Confirm its status | Istanbul | Turkey (Türkiye) | Recruiting |
| Medical Park Florya Hospital Coordinator of this site? Confirm its status | Istanbul | Turkey (Türkiye) | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.