Non-small Cell Lung CancerPhase 3NCT07195695
Beamion LUNG-3: Adjuvant Zongertinib vs Standard Treatment in People With Completely Resected Stage II-IIIB NSCLC Harboring Activating HER2 TKD Mutations
A Phase 3 study testing Zongertinib, Pembrolizumab and Atezolizumab in people with Non-small Cell Lung Cancer, run by Boehringer Ingelheim at 202 sites in 28 countries.
Trial summary
Beamion LUNG-3 study evaluates whether zongertinib, an oral HER2-targeted treatment, can improve outcomes compared with standard adjuvant treatment in adults with completely resected Stage II-IIIB non-small cell lung cancer (NSCLC) whose tumors have activating HER2 tyrosine kinase domain (TKD) mutations. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-small Cell Lung Cancer
- What is being tested?
- Zongertinib, Pembrolizumab and Atezolizumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 202 sitesin 28 countries
- Study dates
- 16 Jan 2026to 2 Sep 2036
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial
- Patients must be ≥18 years old or over the legal age of consent in their country
- Male or female patients. Women of childbearing potential (WOCBP) must be ready and able to use dual highly effective methods of birth control per ICH M3 (R2) that result in a low failure rate of less than 1% per year when used consistently and correctly. A list of contraception methods meeting these criteria is provided in the patient information and in the study protocol
- HER2 mutation: Documented Tyrosine kinase domain (TKD) activating Human epidermal growth factor receptor 2 (HER2) mutations
- Histology and tumor sample: Histologically confirmed diagnosis of primary NSCLC
- An archival tumor tissue sample must be submitted to the central laboratory after inclusion of the patient to retrospectively confirm the HER2 status
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- Staging: Pretherapeutic classification not exceeding Stage IIIB
- Performance status and organ function:
- Eastern Cooperative Oncology Group (ECOG) score of 0 or 1
- Adequate organ function based on laboratory values Further inclusion criteria apply.
Who cannot join
- Diagnosis of NSCLC with mixed histology/positive neuroendocrine markers (synaptophysin/CD56)
- Major surgery (major according to the investigator's assessment) performed within 4 weeks prior to randomization
- Treatment with radiation therapy for primary NSCLC
- Co-occurring actionable mutation with approved targeted therapy (e.g. Epidermal growth factor receptor (EGFR) or Anaplastic lymphoma kinase (ALK))
- Any investigational drug within 5 half-lives of the compound or any of its related material, if known
- History or presence of
Show all 11Show fewer
- Active or known pre-existing or history of non-infectious interstitial lung disease/pneumonitis
- Active infectious disease requiring systemic therapy
- Uncontrolled gastrointestinal disorders affecting drug intake/absorption
- Previous or concomitant malignancies within the last 3 years, except certain effectively treated cancers
- Significant and/or uncontrolled cardiovascular abnormalities, QT interval corrected for heart rate by Fridericia formula (QTcF) >470 msec, or ejection fraction <50% Further exclusion criteria apply.
Trial locations and contacts
202 sites in 28 countries. Contact the study team or a site near you to ask about taking part.
202 sites in 28 countries
China28 sites, 28 recruiting
- Recruiting
China-Japan Friendship Hospital
Beijing, 100029
Boehringer Ingelheim, 4001200553, china@bitrialsupport.com
- Recruiting
Beijing Chest Hospital, Capital Medical University
Beijing, 101149
Boehringer Ingelheim, 4001200553, china@bitrialsupport.com
- Recruiting
The First Hospital of Jilin University
Changchun, 130000
Boehringer Ingelheim, 4001200553, china@bitrialsupport.com
- Recruiting
Xiangya Hospital, Central South University
Changsha, 410008
Boehringer Ingelheim, 4001200553, china@bitrialsupport.com
- Not yet recruiting
Hunan Province Tumor Hospital
Changsha, 410013
Boehringer Ingelheim, 4001200553, china@bitrialsupport.com
- Recruiting
Sichuan Cancer Hospital
Chengdu, 610041
Boehringer Ingelheim, 4001200553, china@bitrialsupport.com
- Recruiting
West China Hospital, Sichuan University
Chengdu, 610041
Boehringer Ingelheim, 4001200553, china@bitrialsupport.com
- Recruiting
The First Affiliated Hospital,Sun Yat-sen University
Guangzhou, 510080
Boehringer Ingelheim, 4001200553, china@bitrialsupport.com
- Recruiting
The First Affiliated Hospital, Zhejiang University
Hangzhou, 310003
Boehringer Ingelheim, 4001200553, china@bitrialsupport.com
- Recruiting
Zhejiang Cancer Hospital
Hangzhou, 310022
Boehringer Ingelheim, 4001200553, china@bitrialsupport.com
- Recruiting
Harbin Medical University Cancer Hospital
Harbin, 150081
Boehringer Ingelheim, 4001200553, china@bitrialsupport.com
- Recruiting
Shandong Cancer Hospital
Jinan, 250117
Boehringer Ingelheim, 4001200553, china@bitrialsupport.com
- Recruiting
Yunnan Provincial Tumor Hospital
Kunming, 650118
Boehringer Ingelheim, 4001200553, china@bitrialsupport.com
- Recruiting
Linyi Cancer Hospital
Linyi, 276034
Boehringer Ingelheim, 4001200553, china@bitrialsupport.com
- Recruiting
The First Affiliated Hospital of Nanchang University
Nanchang, 330006
Boehringer Ingelheim, 4001200553, china@bitrialsupport.com
- Recruiting
Nanjing Drum Tower Hospital
Nanjing, 210008
Boehringer Ingelheim, 4001200553, china@bitrialsupport.com
- Recruiting
Ningbo Second Hospital
Ningbo, 315010
Boehringer Ingelheim, 4001200553, china@bitrialsupport.com
- Recruiting
Shanghai East Hospital
Shanghai, 200121
Boehringer Ingelheim, 4001200553, china@bitrialsupport.com
- Recruiting
Shanghai Pulmonary Hospital
Shanghai, 200433
Boehringer Ingelheim, 4001200553, china@bitrialsupport.com
- Recruiting
Hebei Provincial Tumor Hospital
Shijiazhuang, 050035
Boehringer Ingelheim, 4001200553, china@bitrialsupport.com
- Recruiting
The First Affiliated Hospital of Soochow University
Suzhou, 215006
Boehringer Ingelheim, 4001200553, china@bitrialsupport.com
- Recruiting
Taizhou Hospital of Zhejiang Province
Taizhou, 317099
Boehringer Ingelheim, 4001200553, china@bitrialsupport.com
- Recruiting
Tianjin Cancer Hospital
Tianjin, 300060
Boehringer Ingelheim, 4001200553, china@bitrialsupport.com
- Recruiting
Tianjin Medical University General Hospital
Tianjin, 30052
Boehringer Ingelheim, 4001200553, china@bitrialsupport.com
- Recruiting
Union Hospital Tongji Medical College Huazhong University of Science and Technology
Wuhan, 430056
Boehringer Ingelheim, 4001200553, china@bitrialsupport.com
- Recruiting
The Affiliated Hospital of Xuzhou Medical College
Xuzhou, 221009
Boehringer Ingelheim, 4001200553, china@bitrialsupport.com
- Recruiting
Northern Jiangsu People's Hospital
Yangzhou, 225001
Boehringer Ingelheim, 4001200553, china@bitrialsupport.com
- Not yet recruiting
Henan Cancer Hospital
Zhengzhou, 450008
Boehringer Ingelheim, 4001200553, china@bitrialsupport.com
United States27 sites, 27 recruiting
- Recruiting
Hendrick Health
Abilene, Texas, 79601
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
- Recruiting
Piedmont Cancer Institute
Atlanta, Georgia, 30318
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
- Not yet recruiting
Saint Alphonsus Regional Medical Center - Boise
Boise, Idaho, 83706
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
- Recruiting
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
- Not yet recruiting
Levine Cancer Institute
Charlotte, North Carolina, 28204
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
- Not yet recruiting
Northwestern University
Chicago, Illinois, 60611
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
- Recruiting
University of Illinois Hospital and Health Sciences System
Chicago, Illinois, 60612
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
- Not yet recruiting
Durham VA Health Care System
Durham, North Carolina, 27705
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
- Recruiting
Virginia Cancer Specialists, PC
Fairfax, Virginia, 22031
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
- Recruiting
ClinRé 001-022 (Premier Cancer Care and Infusion Center)
Fresno, California, 93710
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
- Recruiting
OPN Healthcare, Inc.
Glendale, California, 91203
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
- Not yet recruiting
The University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
- Recruiting
Duly Health and Care - Lisle
Lisle, Illinois, 60532
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
- Recruiting
Northwest Georgia Oncology Centers
Marietta, Georgia, 30060
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
- Recruiting
Laura & Isaac Perlmutter Cancer Center at NYU Langone Health
New York, New York, 10016
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
- Recruiting
Memorial Sloan-Kettering Cancer Center
New York, New York, 10065
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
- Recruiting
Community Cancer Trials of Utah
Ogden, Utah, 84405
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
- Recruiting
University of California Irvine
Orange, California, 92868
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
- Recruiting
Mid Florida Hematology and Oncology Center
Orange City, Florida, 32763
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
- Recruiting
Providence Cancer Institute
Portland, Oregon, 97213
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
- Recruiting
Cancer Care Specialists
Reno, Nevada, 89511
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
- Recruiting
Sutter Health
Roseville, California, 95661
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
- Recruiting
University of California San Francisco
San Francisco, California, 94158
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
- Recruiting
Sarcoma Oncology Center
Santa Monica, California, 90403
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
- Recruiting
University of California Los Angeles
Santa Monica, California, 90404
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
- Not yet recruiting
Northern California Kaiser Permanente
Vallejo, California, 94589
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
- Not yet recruiting
George Washington University Cancer Center
Washington D.C., District of Columbia, 20037
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
Japan25 sites, 25 recruiting
- Recruiting
Aichi Cancer Center Hospital
Aichi, Nagoya, 464-8681
Boehringer Ingelheim, 05050508862, nippon@bitrialsupport.com
- Recruiting
Fujita Health University Hospital
Aichi, Toyoake, 470-1192
Boehringer Ingelheim, 05050508862, nippon@bitrialsupport.com
- Not yet recruiting
National Cancer Center Hospital East
Chiba, Kashiwa, 277-8577
Boehringer Ingelheim, 05050508862, nippon@bitrialsupport.com
- Recruiting
Kyushu University Hospital
Fukuoka, Fukuoka, 812-8582
Boehringer Ingelheim, 05050508862, nippon@bitrialsupport.com
- Recruiting
Hospital of the University of Occupational and Environmental Health
Fukuoka, Kitakyushu, 807-8556
Boehringer Ingelheim, 05050508862, nippon@bitrialsupport.com
- Recruiting
Hiroshima University Hospital
Hiroshima, Hiroshima, 734-8551
Boehringer Ingelheim, 05050508862, nippon@bitrialsupport.com
- Recruiting
Hokkaido Cancer Center
Hokkaido, Sapporo, 003-0804
Boehringer Ingelheim, 05050508862, nippon@bitrialsupport.com
- Recruiting
Kitasato University Hospital
Kanagawa, Sagamihara, 252-0375
Boehringer Ingelheim, 05050508862, nippon@bitrialsupport.com
- Recruiting
Kanagawa Cancer Center
Kanagawa, Yokohama, 241-8515
Boehringer Ingelheim, 05050508862, nippon@bitrialsupport.com
- Recruiting
Sendai Kousei Hospital
Miyagi, Sendai, 981-0914
Boehringer Ingelheim, 05050508862, nippon@bitrialsupport.com
- Recruiting
Niigata Cancer Center Hospital
Niigata, Niigata, 951-8566
Boehringer Ingelheim, 05050508862, nippon@bitrialsupport.com
- Recruiting
Okayama University Hospital
Okayama, Okayama, 700-8558
Boehringer Ingelheim, 05050508862, nippon@bitrialsupport.com
- Recruiting
Kansai Medical University Hospital
Osaka, Hirakata, 573-1191
Boehringer Ingelheim, 05050508862, nippon@bitrialsupport.com
- Recruiting
Osaka International Cancer Institute
Osaka, Osaka, 541-8567
Boehringer Ingelheim, 05050508862, nippon@bitrialsupport.com
- Recruiting
Kindai University Hospital
Osaka, Sakai, 590-0197
Boehringer Ingelheim, 05050508862, nippon@bitrialsupport.com
- Recruiting
National Hospital Organization Kinki-Chuo Chest Medical Center
Osaka, Sakai, 591-8555
Boehringer Ingelheim, 05050508862, nippon@bitrialsupport.com
- Recruiting
Saitama Medical University International Medical Center
Saitama, Hidaka, 350-1298
Boehringer Ingelheim, 05050508862, nippon@bitrialsupport.com
- Recruiting
Saitama Cancer Center
Saitama, Kitaadachi-gun, 362-0806
Boehringer Ingelheim, 05050508862, nippon@bitrialsupport.com
- Recruiting
Shizuoka Cancer Center
Shizuoka, Sunto-gun, 411-8777
Boehringer Ingelheim, 05050508862, nippon@bitrialsupport.com
- Recruiting
Jichi Medical University Hospital
Tochigi, Shimotsuke, 329-0498
Boehringer Ingelheim, 05050508862, nippon@bitrialsupport.com
- Recruiting
Juntendo University Hospital
Tokyo, Bunkyo-ku, 113-8431
Boehringer Ingelheim, 05050508862, nippon@bitrialsupport.com
- Recruiting
National Cancer Center Hospital
Tokyo, Chuo-ku, 104-0045
Boehringer Ingelheim, 05050508862, nippon@bitrialsupport.com
- Recruiting
Japanese Foundation for Cancer Research
Tokyo, Koto-ku, 135-8550
Boehringer Ingelheim, 05050508862, nippon@bitrialsupport.com
- Recruiting
Tokyo Medical University Hospital
Tokyo, Shinjuku-ku, 160-0023
Boehringer Ingelheim, 05050508862, nippon@bitrialsupport.com
- Recruiting
Wakayama Medical University Hospital
Wakayama, Wakayama, 641-8510
Boehringer Ingelheim, 05050508862, nippon@bitrialsupport.com
Spain14 sites, 14 recruiting
- Recruiting
Hospital del Mar
Barcelona, 08003
Boehringer Ingelheim, 900876092, espana@bitrialsupport.com
- Recruiting
Hospital Universitari Vall d'Hebron
Barcelona, 08035
Boehringer Ingelheim, 900876092, espana@bitrialsupport.com
- Recruiting
Hospital Universitario De Burgos
Burgos, 09006
Boehringer Ingelheim, 900876092, espana@bitrialsupport.com
- Recruiting
Hospital General Universitario de Elche
Elche, 03203
Boehringer Ingelheim, 900876092, espana@bitrialsupport.com
- Recruiting
Hospital Jerez de la Frontera
Jerez de la Frontera, 11407
Boehringer Ingelheim, 900876092, espana@bitrialsupport.com
- Recruiting
Hospital Universitario Ramon Y Cajal
Madrid, 28034
Boehringer Ingelheim, 900876092, espana@bitrialsupport.com
- Recruiting
Fundación Jiménez Díaz
Madrid, 28040
Boehringer Ingelheim, 900876092, espana@bitrialsupport.com
- Recruiting
Hospital Universitario 12 de Octubre
Madrid, 28041
Boehringer Ingelheim, 900876092, espana@bitrialsupport.com
- Recruiting
Hospital Puerta de Hierro
Majadahonda, 28222
Boehringer Ingelheim, 900876092, espana@bitrialsupport.com
- Recruiting
Hospital Universitario Virgen de la Victoria
Málaga, 29010
Boehringer Ingelheim, 900876092, espana@bitrialsupport.com
- Recruiting
Hospital Universitario de Navarra
Pamplona, 31008
Boehringer Ingelheim, 900876092, espana@bitrialsupport.com
- Recruiting
Salut Sant Joan de Reus
Reus, 43204
Boehringer Ingelheim, 900876092, espana@bitrialsupport.com
- Recruiting
Hospital Virgen del Rocio
Seville, 41013
Boehringer Ingelheim, 900876092, espana@bitrialsupport.com
- Recruiting
Hospital Clinico Universitario de Valencia
Valencia, 46010
Boehringer Ingelheim, 900876092, espana@bitrialsupport.com
Germany9 sites, 9 recruiting
- Not yet recruiting
Charité - Universitätsmedizin Berlin
Berlin, 12203
Boehringer Ingelheim, 08007234742, deutschland@bitrialsupport.com
- Recruiting
Universitätsklinikum Köln (AöR)
Cologne, 50937
Boehringer Ingelheim, 08007234742, deutschland@bitrialsupport.com
- Recruiting
Klinikum Esslingen
Esslingen am Neckar, 73730
Boehringer Ingelheim, 08007234742, deutschland@bitrialsupport.com
- Recruiting
Varisano LungenZentrum (VLZ)
Frankfurt, 65929
Boehringer Ingelheim, 08007234742, deutschland@bitrialsupport.com
- Not yet recruiting
Asklepios Fachkliniken München-Gauting
Gauting, 82131
Boehringer Ingelheim, 08007234742, deutschland@bitrialsupport.com
- Recruiting
LungenClinic Grosshansdorf GmbH
Großhansdorf, 22927
Boehringer Ingelheim, 08007234742, deutschland@bitrialsupport.com
- Recruiting
Thoraxklinik-Heidelberg gGmbH am Universitätsklinikum Heidelberg
Heidelberg, 69126
Boehringer Ingelheim, 08007234742, deutschland@bitrialsupport.com
- Recruiting
Pius-Hospital, Oldenburg
Oldenburg, 26121
Boehringer Ingelheim, 08007234742, deutschland@bitrialsupport.com
- Recruiting
Universitätsklinikum Würzburg AÖR
Würzburg, 97078
Boehringer Ingelheim, 08007234742, deutschland@bitrialsupport.com
France8 sites, 8 recruiting
- Recruiting
Hopital Louis Pradel
Bron, 69677
Boehringer Ingelheim, 0805102354, france@bitrialsupport.com
- Recruiting
HOP Nord
Marseille, 13915
Boehringer Ingelheim, 0805102354, france@bitrialsupport.com
- Recruiting
HOP Nord Laennec
Nantes, 44093
Boehringer Ingelheim, 0805102354, france@bitrialsupport.com
- Recruiting
HOP Tenon - One AP-HP
Paris, 75970
Boehringer Ingelheim, 0805102354, france@bitrialsupport.com
- Recruiting
HOP Pontchaillou
Rennes, 35033
Boehringer Ingelheim, 0805102354, france@bitrialsupport.com
- Recruiting
Centre Régional de Lutte Contre le Cancer Paul Stauss
Strasbourg, 67200
Boehringer Ingelheim, 0805102354, france@bitrialsupport.com
- Recruiting
Hôpital Larrey - CHU de Toulouse
Toulouse, 31059
Boehringer Ingelheim, 0805102354, france@bitrialsupport.com
- Recruiting
Institut Gustave Roussy
Villejuif, 94805
Boehringer Ingelheim, 0805102354, france@bitrialsupport.com
Italy8 sites, 8 recruiting
- Recruiting
Istituto Tumori Giovanni Paolo II
Bari, 70124
Boehringer Ingelheim, 800977373, italia@bitrialsupport.com
- Recruiting
Fondazione IRCCS Istituto Nazionale dei Tumori
Milan, 20133
Boehringer Ingelheim, 800977373, italia@bitrialsupport.com
- Recruiting
Humanitas Istituto Clinico Catanese S.p.A.
Misterbianco (CT), 95045
Boehringer Ingelheim, 800977373, italia@bitrialsupport.com
- Recruiting
Istituto Nazionale IRCCS Tumori Fondazione Pascale
Naples, 80131
Boehringer Ingelheim, 800977373, italia@bitrialsupport.com
- Recruiting
AOU San Luigi Gonzaga
Orbassano (TO), 10043
Boehringer Ingelheim, 800977373, italia@bitrialsupport.com
- Recruiting
Istituti Fisioterapici Ospitalieri
Roma, 00144
Boehringer Ingelheim, 800977373, italia@bitrialsupport.com
- Recruiting
Istituto Clinico Humanitas
Rozzano (MI), 20089
Boehringer Ingelheim, 800977373, italia@bitrialsupport.com
- Recruiting
Azienda Ospedaliera Universitaria Integrata Verona
Verona, 37126
Boehringer Ingelheim, 800977373, italia@bitrialsupport.com
South Korea8 sites, 8 recruiting
- Recruiting
National Cancer Center
Goyang, 10408
Boehringer Ingelheim, 0808802084, namhan@bitrialsupport.com
- Recruiting
Seoul National University Bundang Hospital
Seongnam, 13620
Boehringer Ingelheim, 0808802084, namhan@bitrialsupport.com
- Recruiting
Seoul National University Hospital
Seoul, 03080
Boehringer Ingelheim, 0808802084, namhan@bitrialsupport.com
- Recruiting
Severance Hospital
Seoul, 03722
Boehringer Ingelheim, 0808802084, namhan@bitrialsupport.com
- Recruiting
Asan Medical Center
Seoul, 05505
Boehringer Ingelheim, 0808802084, namhan@bitrialsupport.com
- Recruiting
Samsung Medical Center
Seoul, 06351
Boehringer Ingelheim, 0808802084, namhan@bitrialsupport.com
- Recruiting
The Catholic University of Korea, St.Vincent's Hospital
Suwon, 16247
Boehringer Ingelheim, 0808802084, namhan@bitrialsupport.com
- Recruiting
Ajou University Hospital
Suwon, 16499
Boehringer Ingelheim, 0808802084, namhan@bitrialsupport.com
Brazil7 sites, 7 recruiting
- Recruiting
Hospital de Amor
Barretos, 14784-400
Boehringer Ingelheim, 08008919295, brasil@bitrialsupport.com
- Recruiting
NewData Clinical Research - Maceió
Maceió, 57020-360
Boehringer Ingelheim, 08008919295, brasil@bitrialsupport.com
- Recruiting
Centro de Pesquisa Oncology Natal
Natal, 59020-400
Boehringer Ingelheim, 08008919295, brasil@bitrialsupport.com
- Recruiting
Centro Gaúcho Integrado de Oncologia, Hematologia, Ensino e Pesquisa
Porto Alegre, 90110-270
Boehringer Ingelheim, 08008919295, brasil@bitrialsupport.com
- Recruiting
CEPHO - Centro de Estudos e Pesquisas em Hematologia e Oncologia
Santo André, 09060-650
Boehringer Ingelheim, 08008919295, brasil@bitrialsupport.com
- Recruiting
ICESP - Instituto do Cancer do Estado de Sao Paulo
São Paulo, 01246-000
Boehringer Ingelheim, 08008919295, brasil@bitrialsupport.com
- Recruiting
A.C. Camargo
São Paulo, 01509-010
Boehringer Ingelheim, 08008919295, brasil@bitrialsupport.com
Turkey (Türkiye)7 sites, 7 recruiting
- Recruiting
Adana Şehir Hastanesi
Adana
Boehringer Ingelheim, 08006212470, turkiye@bitrialsupport.com
- Recruiting
Medical Park Seyhan Hastanesi
Adana
Boehringer Ingelheim, 08006212470, turkiye@bitrialsupport.com
- Recruiting
Sağlık Bilimleri Üniversitesi Gülhane Eğitim ve Araştırma Hastanesi
Ankara, 06018
Boehringer Ingelheim, 08006212470, turkiye@bitrialsupport.com
- Recruiting
Ankara University Medical Faculty Hospital
Ankara
Boehringer Ingelheim, 08006212470, turkiye@bitrialsupport.com
- Recruiting
Dr. Abdurrahman Yurtaslan Ankara Onkoloji Eğitim ve Araştırma Hastanesi
Ankara
Boehringer Ingelheim, 08006212470, turkiye@bitrialsupport.com
- Not yet recruiting
Medeniyet University
Istanbul, 34862
Boehringer Ingelheim, 08006212470, turkiye@bitrialsupport.com
- Recruiting
Ankara Bilkent Sehir Hastanesi
Türkiye
Boehringer Ingelheim, 08006212470, turkiye@bitrialsupport.com
Taiwan6 sites, 6 recruiting
- Recruiting
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, 807
Boehringer Ingelheim, 0809092098, taiwan@bitrialsupport.com
- Recruiting
China Medical University Hospital
Taichung, 40447
Boehringer Ingelheim, 0809092098, taiwan@bitrialsupport.com
- Recruiting
National Taiwan University Hospital
Taipei, 10048
Boehringer Ingelheim, 0809092098, taiwan@bitrialsupport.com
- Recruiting
Taipei Veterans General Hospital
Taipei, 11217
Boehringer Ingelheim, 0809092098, taiwan@bitrialsupport.com
- Recruiting
Tri-Service General Hospital
Taipei, 114
Boehringer Ingelheim, 0809092098, taiwan@bitrialsupport.com
- Recruiting
Chang Gung Memorial Hospital, Linkou
Taoyuan City, 333
Boehringer Ingelheim, 0809092098, taiwan@bitrialsupport.com
United Kingdom6 sites, 6 recruiting
- Not yet recruiting
Velindre Cancer Centre
Cardiff, CF14 2TL
Boehringer Ingelheim, 08000514022, unitedkingdom@bitrialsupport.com
- Recruiting
Western General Hospital
Edinburgh, EH4 2XU
Boehringer Ingelheim, 08000514022, unitedkingdom@bitrialsupport.com
- Recruiting
Guy's Hospital
London, SE1 9RT
Boehringer Ingelheim, 08000514022, unitedkingdom@bitrialsupport.com
- Recruiting
The Royal Marsden Hospital, Chelsea
London, SW3 6JJ
Boehringer Ingelheim, 08000514022, unitedkingdom@bitrialsupport.com
- Recruiting
The Christie Hospital
Manchester, M20 4BX
Boehringer Ingelheim, 08000514022, unitedkingdom@bitrialsupport.com
- Recruiting
The Royal Marsden Hospital, Sutton
Sutton, SM2 5PT
Boehringer Ingelheim, 08000514022, unitedkingdom@bitrialsupport.com
Argentina5 sites, 5 recruiting
- Recruiting
Centro de Investigaciones Medicas y Desarrollo LC S.R.L. (LC Investigacion)
CABA, 1185
Boehringer Ingelheim, 08002667801, argentina@bitrialsupport.com
- Recruiting
Hospital Britanico de Buenos Aires
CABA, 1280AEB
Boehringer Ingelheim, 08002667801, argentina@bitrialsupport.com
- Recruiting
Centro Oncologico Korben
CABA, 1426
Boehringer Ingelheim, 08002667801, argentina@bitrialsupport.com
- Recruiting
Clinica Adventista Belgrano
CABA, 1430
Boehringer Ingelheim, 08002667801, argentina@bitrialsupport.com
- Recruiting
Instituto Medico Especializado Alexander Fleming
Ciudad Autónoma de Bs As, C1426ANZ
Boehringer Ingelheim, 08002667801, argentina@bitrialsupport.com
Australia5 sites, 5 recruiting
- Not yet recruiting
Flinders Medical Centre
Bedford Park, South Australia, 5042
Boehringer Ingelheim, 1800271035, australia@bitrialsupport.com
- Recruiting
Austin Health
Heidelberg, 3084
Boehringer Ingelheim, 1800271035, australia@bitrialsupport.com
- Recruiting
St John of God Subiaco Hospital
Subiaco, Western Australia, 6008
Boehringer Ingelheim, 1800271035, australia@bitrialsupport.com
- Recruiting
Royal North Shore Hospital
Sydney, 2065
Boehringer Ingelheim, 1800271035, australia@bitrialsupport.com
- Recruiting
Princess Alexandra Hospital
Woolloongabba, 4102
Boehringer Ingelheim, 1800271035, australia@bitrialsupport.com
Israel5 sites, 5 recruiting
- Not yet recruiting
Rambam Health Care Campus
Haifa, 3109601
Boehringer Ingelheim, 1809388162, israel@bitrialsupport.com
- Not yet recruiting
Shaare Zedek Medical Center
Jerusalem, 9103102
Boehringer Ingelheim, 1809388162, israel@bitrialsupport.com
- Not yet recruiting
Meir Medical Center
Kfar Saba, 44281
Boehringer Ingelheim, 1809388162, israel@bitrialsupport.com
- Not yet recruiting
Sheba Medical Center
Ramat Gan, 5262000
Boehringer Ingelheim, 1809388162, israel@bitrialsupport.com
- Not yet recruiting
Sourasky Medical Center
Tel Aviv, 6093246
Boehringer Ingelheim, 1809388162, israel@bitrialsupport.com
Mexico5 sites, 5 recruiting
- Not yet recruiting
Centro Oncologico Internacional
Jalisco, 45640
Boehringer Ingelheim, 018000623749, mexico@bitrialsupport.com
- Not yet recruiting
Centro Oncologico Personalizado
México, 06760
Boehringer Ingelheim, 018000623749, mexico@bitrialsupport.com
- Recruiting
Instituto Nacional de Cancerologia
México, 14080
Boehringer Ingelheim, 018000623749, mexico@bitrialsupport.com
- Recruiting
Centro de Infusion Profesional Integral (CIPI)
Mexico City, 14210
Boehringer Ingelheim, 018000623749, mexico@bitrialsupport.com
- Recruiting
Centro Medico Zambrano Hellion
Monterrey, 66278
Boehringer Ingelheim, 018000623749, mexico@bitrialsupport.com
Hong Kong4 sites, 4 recruiting
- Recruiting
Queen Elizabeth Hospital-Hong Kong-51727
Hong Kong, 51727
Boehringer Ingelheim, 800965365, hongkong@bitrialsupport.com
- Recruiting
Prince of Wales Hospital-Hong Kong-20715
Hong Kong, 999077
Boehringer Ingelheim, 800965365, hongkong@bitrialsupport.com
- Recruiting
Princess Margaret Hospital
Hong Kong, 999077
Boehringer Ingelheim, 800965365, hongkong@bitrialsupport.com
- Recruiting
Queen Mary Hospital
Hong Kong
Boehringer Ingelheim, 800965365, hongkong@bitrialsupport.com
Portugal4 sites, 4 recruiting
- Recruiting
Hospital CUF Tejo
Lisbon, 1350-352
Boehringer Ingelheim, 800856070, portugal@bitrialsupport.com
- Recruiting
Hospital da Luz
Lisbon, 1500-650
Boehringer Ingelheim, 800856070, portugal@bitrialsupport.com
- Recruiting
Hospital CUF Porto
Porto, 4100-180
Boehringer Ingelheim, 800856070, portugal@bitrialsupport.com
- Not yet recruiting
IPO Porto Francisco Gentil, EPE
Porto, 4200-072
Boehringer Ingelheim, 800856070, portugal@bitrialsupport.com
Romania4 sites, 4 recruiting
- Recruiting
Lotus Med
Bucharest, 012292
Boehringer Ingelheim, 0800895209, romania@bitrialsupport.com
- Recruiting
Memorial Healthcare International
Bucharest, 013823
Boehringer Ingelheim, 0800895209, romania@bitrialsupport.com
- Recruiting
Ovidius Clinical Hospital S.R.L
Ovidiu, 905900
Boehringer Ingelheim, 0800895209, romania@bitrialsupport.com
- Not yet recruiting
Polaris Medical S.A.
Suceagu/ Cluj Napoca, 407062
Boehringer Ingelheim, 0800895209, romania@bitrialsupport.com
Belgium3 sites, 3 recruiting
- Recruiting
Universitair Ziekenhuis Antwerpen
Edegem, 2650
Boehringer Ingelheim, 080049616, belgique@bitrialsupport.com
- Recruiting
UZ Leuven
Leuven, 3000
Boehringer Ingelheim, 080049616, belgique@bitrialsupport.com
- Recruiting
Centre Hospitalier Universitaire de Liège
Liège, 4000
Boehringer Ingelheim, 080049616, belgique@bitrialsupport.com
Greece3 sites, 3 recruiting
- Not yet recruiting
Henry Dunant Hospital, Athens
Athens, 11526
Boehringer Ingelheim, 008000000092, hellas@bitrialsupport.com
- Not yet recruiting
Chest Hospital of Athens "Sotiria"
Athens, 11527
Boehringer Ingelheim, 008000000092, hellas@bitrialsupport.com
- Not yet recruiting
University General Hospital Attikon
Athens, 12462
Boehringer Ingelheim, 008000000092, hellas@bitrialsupport.com
Austria2 sites, 2 recruiting
- Not yet recruiting
Medical University of Innsbruck
Innsbruck, A-6020
Boehringer Ingelheim, 0800017900, oesterreich@bitrialsupport.com
- Recruiting
Clinic Floridsdorf
Vienna, 1210
Boehringer Ingelheim, 0800017900, oesterreich@bitrialsupport.com
Canada2 sites, 2 recruiting
- Recruiting
Cross Cancer Institute (University of Alberta)
Edmonton, Alberta, T6G 1Z2
Boehringer Ingelheim, 18336022346, canada@bitrialsupport.com
- Not yet recruiting
Princess Margaret Cancer Centre
Toronto, Ontario, M5G 2M9
Boehringer Ingelheim, 18336022346, canada@bitrialsupport.com
Chile2 sites, 2 recruiting
- Recruiting
Centro de Estudios Clinicos SAGA
Providencia, 7500653
Boehringer Ingelheim, 800392345, chile@bitrialsupport.com
- Recruiting
Bradford Hill- Centro de Investigacion Clinica
Recoleta, 8420383
Boehringer Ingelheim, 800392345, chile@bitrialsupport.com
Sweden2 sites, 2 recruiting
- Recruiting
Sahlgrenska Universitetsjukhuset
Gothenburg, 413 46
Boehringer Ingelheim, 0200880001, sverige@bitrialsupport.com
- Recruiting
Karolinska Universitetssjukhuset Solna
Stockholm, 171 76
Boehringer Ingelheim, 0200880001, sverige@bitrialsupport.com
Denmark1 site, 1 recruiting
- Not yet recruiting
Sjællands Universitetshospital
Roskilde, 4000
Boehringer Ingelheim, 80711822, danmark@bitrialsupport.com
Netherlands1 site, 1 recruiting
- Recruiting
Nederlands Kanker Instituut - Antoni van Leeuwenhoek Amsterdam (METC AVL)
Amsterdam, 1066CX
Boehringer Ingelheim, 08000204613, nederland@bitrialsupport.com
Singapore1 site, 1 recruiting
- Recruiting
National Cancer Centre Singapore
Singapore, 168583
Boehringer Ingelheim, 8001207344, singapore@bitrialsupport.com
About this study
Official title: Beamion LUNG-3: A Randomized, Controlled, Multi-center Trial Evaluating Zongertinib as an Adjuvant Monotherapy Compared With Standard of Care in Patients With Early-stage, Resectable Non-small Cell Lung Cancer (Stage II-IIIB) Harboring Tyrosine Kinase Domain Activating HER2 Mutations
Beamion LUNG-3 study evaluates whether zongertinib, an oral HER2-targeted treatment, can improve outcomes compared with standard adjuvant treatment in adults with completely resected Stage II-IIIB non-small cell lung cancer (NSCLC) whose tumors have activating HER2 tyrosine kinase domain (TKD) mutations. Eligible participants must have undergone curative-intent surgery and received guideline-appropriate perioperative systemic therapy, either neoadjuvant platinum-based chemotherapy with or without immunotherapy, or adjuvant platinum-based chemotherapy.
Participants are randomized 1:1 to receive zongertinib or standard of care, which may consist of approved adjuvant immunotherapy or active surveillance, based on local practice guidelines. The main purpose of the study is to determine whether zongertinib can prolong disease-free survival compared to standard treatment. Safety and patient-reported outcomes are also assessed.
Read the detailed description
This is a global, randomized, open-label, Phase 3 study designed to assess the efficacy and safety of zongertinib as adjuvant therapy in participants with completely resected Stage II-IIIB NSCLC and HER2 TKD-activating mutations.
Participants must have undergone complete resection and received perioperative systemic therapy consistent with current standards, including either neoadjuvant platinum-based chemotherapy with or without immunotherapy, or adjuvant platinum-based chemotherapy.
After completing surgery and required systemic treatment, eligible participants are randomized 1:1 to receive either Zongertinib taken orally once daily for up to 3 years, or standard treatment, which may include an approved adjuvant immunotherapy agent administered according to its label, or observation, depending on local clinical practice and patient status.
The primary objective is to evaluate whether zongertinib improves disease-free survival (DFS) compared with standard treatment. Secondary objectives include overall survival (OS), safety, tolerability, and patient-reported outcomes.
- Conditions
- Non-small Cell Lung Cancer
- Being tested
- Zongertinib, Pembrolizumab, Atezolizumab, Durvalumab, Nivolumab
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZongertinibDrug
Also called BI 1810631, Hernexeos®
Zongertinib
PembrolizumabDrug
Pembrolizumab
AtezolizumabDrug
Atezolizumab
DurvalumabDrug
Durvalumab
NivolumabDrug
Nivolumab
| Study group | Role | What they receive |
|---|---|---|
| Zongertinib treatment arm | Experimental | Not described Receives: Drug: Zongertinib |
| Standard of Care (SoC) treatment arm | Active comparator | Not described Receives: Drug: Pembrolizumab; Drug: Atezolizumab; Drug: Durvalumab; Drug: Nivolumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease-free survival (DFS) by investigator's assessment
DFS is defined as the time from randomization until recurrence of tumor or death from any cause, whichever occurs earlier
Measured: up to 8 years and 5 months
Secondary outcomes (2)
Key secondary endpoint: Overall survival (OS), defined as the time from randomization until death from any cause
Measured: up to 8 years and 5 months
Occurrence of trial-related Adverse Events (AEs) ≥ Grade 3 from first treatment administration (or from randomization for patients in the observation arm) until the earliest of tumor recurrence or 3 years since treatment start
AEs are graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 5.0
Measured: up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2025
- Study start16 Jan 2026
- Primary completion26 Feb 2032 (estimated)
- Study completion2 Sep 2036 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Boehringer IngelheimThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07195695
- Sponsor's protocol ID
- 1479-0032
- Other IDs
- U1111-1320-6149, 2025-521284-12-00, 2025
- Status last verified
- Oct 2026
- First submitted
- 25 Sep 2025
- Last updated
- 15 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Once the criteria in section "Time Frame" are fulfilled, researchers can use the following link https://www.clinicalstudies.boehringer-ingelheim.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement". Furthermore, researchers can request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website.