New hope for rare lung cancer: targeted drug trial launches
NCT ID NCT07185997
First seen Jun 27, 2026 · Last updated Sep 02, 2026 · Updated 5 times
Summary
This study tests a new drug, firmonertinib, against two standard treatments for people with advanced non-small-cell lung cancer that has certain rare genetic changes (EGFR PACC mutations). About 480 participants who have not had prior treatment for advanced disease will be randomly assigned to receive firmonertinib or a standard drug. The goal is to see if firmonertinib can better delay cancer growth or improve response rates.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
-
About 480 people
The number the study aims to enrol. It can still change while the study runs.
- Started
-
Dec 2025
- Expected to finish
-
Dec 2030
An estimate. End dates often move.
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 years and older
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Advanced non-small cell lung cancer are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
-
The places running it
118 sites in 17 countries. The list below names each one and where it is.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
-
Affiliated Hospital of Nantong University
RECRUITINGNantong, Jiangsu, 226001, China
-
Aichi Cancer Center
RECRUITINGNagoya, Aichi-ken, 464-8681, Japan
-
Alberta Health Services, Tom Baker Cancer Centre
RECRUITINGCalgary, Alberta, T2N 4N2, Canada
-
Anatalya Province
RECRUITINGAntalya, 07050, Turkey (Türkiye)
-
Asan Medical Center
RECRUITINGSeoul, 05505, South Korea
-
Athens Medical Center S.A., European Interbalkan Medical Center
RECRUITINGThessaloniki, 570 01, Greece
-
Austin Health
RECRUITINGHeidelberg, Victoria, 3084, Australia
-
BC Cancer Vancouver Centre
RECRUITINGVancouver, British Columbia, V5Z 4E6, Canada
-
Beijing Chest Hospital, Capital Medical University
RECRUITINGBeijing, Beijing Municipality, 101149, China
-
Blacktown Cancer and Haematology Centre
RECRUITINGBlacktown, New South Wales, 2148, Australia
-
Brampton Civic Hospital, William Osler Health Centre
RECRUITINGBrampton, Ontario, L6R 3J7, Canada
-
Cancer Hospital of Shantou University Medical College
RECRUITINGShantou, Guangdong, 515000, China
-
Centre Francois Baclesse
RECRUITINGCaen, Calvados, 14076, France
-
Centre Leon-Berard
RECRUITINGLyon, 69373, France
-
China shenyang the tenth People's Hospital
RECRUITINGShenyang, Liaoning, 110044, China
-
Chonnam National University Hwasun Hospital
RECRUITINGHwasun, Jeollanam-do, 58128, South Korea
-
Chris O'Brien Lifehouse
RECRUITINGCamperdown, New South Wales, 2050, Australia
-
Chulabhorn Hospital
RECRUITINGLak Si, Bangkok, 10210, Thailand
-
Curie Oncology (Farrer)
RECRUITINGSingapore, 217562, Singapore
-
Faculty of Medicine Vajira Hospital, Navamindradhiraj University
RECRUITINGBangkok, 10300, Thailand
-
Fox Chase Cancer Center
RECRUITINGPhiladelphia, Pennsylvania, 19111, United States
-
Fujita Health University Hospital
RECRUITINGToyoake, Aichi-ken, 470-1192, Japan
-
Gachon University Gil Medical Center
RECRUITINGIncheon, 21565, South Korea
-
GenesisCare North Shore Health Hub
RECRUITINGSt Leonards, New South Wales, 2065, Australia
-
Gulhane Training and Research Hospital
RECRUITINGAnkara, 06010, Turkey (Türkiye)
-
Harbin Medical University Cancer Hospital
RECRUITINGHarbin, Heilongjiang, 150081, China
-
Henry Dunant Hospital Center
RECRUITINGAthens, 115 26, Greece
-
Henry Ford Cancer Institute
RECRUITINGDetroit, Michigan, 48202, United States
-
Hopital Larrey
RECRUITINGToulouse, Occitanie, 31059, France
-
Hopital Nord Guilaume-et-Rene-Laennec CHU de Nantes
RECRUITINGSaint-Herblain, 44093, France
-
Hospices Civil de Lyon
RECRUITINGBron, Auvergne-Rhône-Alpes, 69500, France
-
Hospital Clinic de Barcelona
RECRUITINGBarcelona, 08036, Spain
-
Hospital Kuala Lumpur
RECRUITINGKuala Lumpur, WP Kuala Lumpur, 50586, Malaysia
-
Hospital Nord de Marseille
RECRUITINGMarseille, Bouches-du-Rhone, 13915, France
-
Hospital QuironSalud Malaga
RECRUITINGMálaga, 29004, Spain
-
Hospital Universitari Son Espases
RECRUITINGPalma, Balearic Islands, 07120, Spain
-
Hospital Universitario Central de Asturias
RECRUITINGOviedo, 33011, Spain
-
Hospital Universitario y Politecnico La Fe
RECRUITINGValencia, 46026, Spain
-
Humanity and Health Clinical Trial Centre
RECRUITINGCentral, Hong Kong
-
Hyogo Cancer Center
RECRUITINGAkashi-shi, Hyōgo, 673-8558, Japan
-
Illinois Cancer Specialists
RECRUITINGArlington Heights, Illinois, 60005, United States
-
Insitut de Canderologie d I'Ouest
RECRUITINGSaint-Herblain, 44805, France
-
Istinye University Bahcesehir Liv Hospital
RECRUITINGIstanbul, 34517, Turkey (Türkiye)
-
Istituto Europeo di Oncologia (IEO)
RECRUITINGMilan, 20141, Italy
-
Jiangsu Province Hospital
RECRUITINGNanjing, Jiangsu, 210029, China
-
Kaiser Permanente Medical Center
RECRUITINGVallejo, California, 94589, United States
-
Kangbuk Samsung Hospital
RECRUITINGSeoul, 03181, South Korea
-
Kansai Medical University Hospital
RECRUITINGHirakata-shi, Osaka, 573-1191, Japan
-
Kaohsiung Medical University Chung-Ho Memorial Hospital
RECRUITINGKaohsiung City, 807, Taiwan
-
Kurume University Hospital
RECRUITINGKurume-Shi, Fukuoka, 830-0011, Japan
-
Kyung Hee University Hospital
RECRUITINGSeoul, 02447, South Korea
-
Laura & Isaac Perlmutter Cancer Center at NYU Langone Health
RECRUITINGNew York, New York, 10016, United States
-
Mahidol University - Siriraj Hospital
RECRUITINGBangkoknoi, Bangkok, 10700, Thailand
-
Medical Park Florya Hospital
RECRUITINGIstanbul, 34295, Turkey (Türkiye)
-
Memorial Ankara Hospital
RECRUITINGAnkara, Ankara, 06520, Turkey (Türkiye)
-
Miyagi Cancer Center
RECRUITINGNatori-shi, Miyagi, 981-1293, Japan
-
Nanjing Drum Tower Hospital
RECRUITINGNanjing, Jiangsu, 210031, China
-
National Cancer Center Hospital
RECRUITINGChuo-ku, Tokyo, 104-0045, Japan
-
National Cancer Center Hospital East
RECRUITINGKashiwa, Chiba, 277-8577, Japan
-
National Cancer Centre Singapore
RECRUITINGSingapore, 168583, Singapore
-
National Hospital Organization Hokkaido Cancer Center
RECRUITINGSapporo, Hokkaido, 003-0804, Japan
-
National Taiwan University Cancer Center
RECRUITINGTaipei, 106, Taiwan
-
Niigata Cancer Center Hospital
RECRUITINGNiigata, Niigata, 951-8566, Japan
-
Nippon Medical School Hospital
RECRUITINGBunkyo-ku, Tokyo, 113-8603, Japan
-
Northwell Health/R.J. Zuckerberg Cancer Center
RECRUITINGLake Success, New York, 11042, United States
-
Ohio State University Hospitals
RECRUITINGColumbus, Ohio, 43210, United States
-
OncoCar Cancer Centre
RECRUITINGPetaling Jaya, Selangor, 47810, Malaysia
-
Peking University People's Hospital
RECRUITINGBeijing, Beijing Municipality, 100044, China
-
Prince of Songkla Hospital
RECRUITINGHat Yai, Changwat Songkhla, 90110, Thailand
-
Prince of Wales Hospital
RECRUITINGShatin, New Territories, Hong Kong
-
Princess Margaret Cancer Centre - University Health Network
RECRUITINGToronto, Ontario, M5G 2M9, Canada
-
Profile of The Third Xiangya Hospital of Central South University
RECRUITINGChangsha, Hunan, 410013, China
-
Providence St. Joseph Hospital
RECRUITINGOrange, California, 92868, United States
-
Queen Mary Hospital
RECRUITINGHong Kong, Hong Kong, 000000, Hong Kong
-
SOC Oncologia Medica e dei Tumori Immuno-correlati
RECRUITINGAviano, 33081, Italy
-
Samsung Medical Center
RECRUITINGSeoul, 06351, South Korea
-
Shanghai Chest Hospital
RECRUITINGShanghai, Shanghai Municipality, 20030, China
-
Shanxi Cancer Hospital
RECRUITINGTaiyuan, Shanxi, 30009, China
-
Shenandoah Oncology, P.C.
RECRUITINGWinchester, Virginia, 22601, United States
-
Sichuan Cancer Hospital
RECRUITINGChengdu, Sichuan, 610213, China
-
St. Jude Medical Center
RECRUITINGFullerton, California, 92835, United States
-
Sunnybrook Research Institute
RECRUITINGToronto, Ontario, M4N 3M5, Canada
-
Swedish Cancer Institute
RECRUITINGEdmonds, Washington, 98026, United States
-
Taichung Veterans General Hospital
RECRUITINGTaichung, 407219, Taiwan
-
Taipei Veterans General Hospital
RECRUITINGTaipei, 11217, Taiwan
-
Tan Tok Seng Hospital
RECRUITINGSingapore, 308433, Singapore
-
Texas Oncology
RECRUITINGDallas, Texas, 75246, United States
-
The Affiliated Hospital of Inner Mongolia Medical University
RECRUITINGHohhot, Inner Mongolia, 010030, China
-
The Affiliated Hospital of Qingdao University
RECRUITINGQingdao, Shandong, 276001, China
-
The Catholic University of Korea, St. Vincent's Hospital
RECRUITINGSuwon, Gyeonggi-do, 16247, South Korea
-
The Christie NHS Foundation Trust
RECRUITINGManchester, England, M20 4BX, United Kingdom
-
The First Affiliated Hospital of Henan Medical University
RECRUITINGXinxiang, Henan, 453100, China
-
The First Affiliated Hospital of Henan University of Science & Technology
RECRUITINGLuoyang, Henan, 47100, China
-
The First Affiliated Hospital of Nanchang University
RECRUITINGNanchang, Jiangxi, 330200, China
-
The First Affiliated Hospital of Zhengzhou University
RECRUITINGZhengzhou, Henan, 450008, China
-
The First People's Hospital of Foshan
RECRUITINGFoshan, Guangdong, 528000, China
-
The Fourth Hospital of Hebei Medical University
RECRUITINGShijiazhuang, Hebei, 50011, China
-
The Ottawa Hospital Cancer Centre
RECRUITINGOttawa, Ontario, K1H 8L6, Canada
-
The Royal Marsden NHS Foundation Trust
RECRUITINGLondon, SW3 6JJ, United Kingdom
-
The University of Texas MD Anderson Cancer Center
RECRUITINGHouston, Texas, 77030, United States
-
Thoracic General Hospital of Athens I Sotiria
RECRUITINGThessaloniki, 570 01, Greece
-
Tianjin Chest Hospital
RECRUITINGTianjin, Tianjin Municipality, 300222, China
-
Tianjin Medical University Cancer Institute & Hospital
RECRUITINGTianjin, Tianjin Municipality, 300222, China
-
Tokyo Metropolitan Komagome Hospital
RECRUITINGBunkyō-Ku, Tokyo, 113-8677, Japan
-
UCSF Medical Center-Mission Bay
RECRUITINGSan Francisco, California, 94158, United States
-
USC/Norris Comprehensive Cancer Center
RECRUITINGLos Angeles, California, 90033, United States
-
Union Hospital Tongji Medical College Huazhong University Of Science And Technology
RECRUITINGWuhan, Hubei, 430000, China
-
University College London Hospitals NHS Foundation Trust
RECRUITINGLondon, England, NW1 2PG, United Kingdom
-
University General Hospital Attikon - General Hospital of West Attica H AGIA VARVARA
RECRUITINGAthens, 124 62, Greece
-
University of California Davis Comprehensive Cancer Center
RECRUITINGSacramento, California, 95817, United States
-
University of Colorado Health
RECRUITINGAurora, Colorado, 80045, United States
-
University of Illinois Hospital and Health Sciences Systems
RECRUITINGChicago, Illinois, 60612, United States
-
University of Virginia
RECRUITINGCharlottesville, Virginia, 22903, United States
-
Virginia Cancer Specialists
RECRUITINGFairfax, Virginia, 22031, United States
-
Weifang People's Hospital
RECRUITINGWeifang, Shandong, 261057, China
-
Yunnan Cancer Hospital
RECRUITINGKunming, Yunnan, 650118, China
-
Zhejiang Cancer Hospital
RECRUITINGHangzhou, Zhejiang, 310022, China
-
Zhongshan Hospital Xiamen University
RECRUITINGXiamen, Fujian, 361004, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Two-Drug combo targets stubborn KRAS lung cancer
- Smaller chest drain may speed recovery after lung cancer surgery
- Gut bacteria may hold clues to why some cancer treatments work better
- Breath-Tracking sensor aims to sharpen lung cancer scans
- Can PET scan signals predict who beats lung cancer with immunotherapy?
- Two-Drug combo takes aim at Hard-to-Treat lung cancer