Beamion LUNG-3: Adjuvant Zongertinib vs Standard Treatment in People With Completely Resected Stage II-IIIB NSCLC Harboring Activating HER2 TKD Mutations
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
3 other identifiers
interventional
400
27 countries
197
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3 nonsmall-cell-lung-cancer
Started Jan 2026
Longer than P75 for phase_3 nonsmall-cell-lung-cancer
197 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 25, 2025
CompletedFirst Posted
Study publicly available on registry
September 29, 2025
CompletedStudy Start
First participant enrolled
January 16, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 26, 2032
ExpectedStudy Completion
Last participant's last visit for all outcomes
September 2, 2036
June 1, 2026
May 1, 2026
6.1 years
September 25, 2025
May 29, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
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
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
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
up to 3 years
Study Arms (2)
Zongertinib treatment arm
EXPERIMENTALStandard of Care (SoC) treatment arm
ACTIVE COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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
- Staging: Pretherapeutic classification not exceeding Stage IIIB
- Performance status and organ function:
- Eastern Cooperative Oncology Group (ECOG) score of 0 or 1
You may not qualify if:
- 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
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (199)
ClinRé 001-022 (Premier Cancer Care and Infusion Center)
Fresno, California, 93710, United States
OPN Healthcare, Inc.
Glendale, California, 91203, United States
University of California Irvine
Irvine, California, 92697, United States
Sutter Health
Roseville, California, 95661, United States
University of California San Francisco
San Francisco, California, 94143, United States
Sarcoma Oncology Center
Santa Monica, California, 90403, United States
University of California Los Angeles
Santa Monica, California, 90404, United States
Northern California Kaiser Permanente
Vallejo, California, 94589, United States
George Washington University Cancer Center
Washington D.C., District of Columbia, 20037, United States
Mid Florida Hematology and Oncology Center
Orange City, Florida, 32763, United States
Piedmont Cancer Institute
Atlanta, Georgia, 30318, United States
Northwest Georgia Oncology Centers
Marietta, Georgia, 30060, United States
Saint Alphonsus Regional Medical Center - Boise
Boise, Idaho, 83706, United States
Northwestern University
Chicago, Illinois, 60611, United States
University of Illinois Hospital and Health Sciences System
Chicago, Illinois, 60612, United States
Duly Health and Care - Lisle
Lisle, Illinois, 60532, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215, United States
Cancer Care Specialists
Reno, Nevada, 89511, United States
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03756, United States
Laura & Isaac Perlmutter Cancer Center at NYU Langone Health
New York, New York, 10016, United States
Memorial Sloan-Kettering Cancer Center
New York, New York, 10065, United States
Levine Cancer Institute
Charlotte, North Carolina, 28204, United States
Durham VA Health Care System
Durham, North Carolina, 27705, United States
Providence Cancer Institute
Portland, Oregon, 97213, United States
Providence Cancer Institute
Portland, Oregon, 97225, United States
Hendrick Health
Abilene, Texas, 79601, United States
The University of Texas MD Anderson Cancer Center
Houston, Texas, 77030, United States
Community Cancer Trials of Utah
Ogden, Utah, 84405, United States
Virginia Cancer Specialists, PC
Fairfax, Virginia, 22031, United States
Centro de Investigaciones Médicas y Desarrollo LC S.R.L. (LC Investigación)
CABA, 1185, Argentina
Hospital Britanico de Buenos Aires
CABA, 1280AEB, Argentina
Centro Oncologico Korben
CABA, 1426, Argentina
Clinica Adventista Belgrano
CABA, 1430, Argentina
Instituto Medico Especializado Alexander Fleming
Capital Federal, C1426ANZ, Argentina
Royal North Shore Hospital
Sydney, New South Wales, 2065, Australia
Princess Alexandra Hospital
Woolloongabba, Queensland, 4102, Australia
Flinders Medical Centre
Bedford Park, South Australia, 5042, Australia
Austin Health
Heidelberg, Victoria, 3084, Australia
St John of God Subiaco Hospital
Subiaco, Western Australia, 6008, Australia
Medical University of Innsbruck
Innsbruck, A-6020, Austria
Clinic Floridsdorf
Vienna, 1210, Austria
Edegem - UNIV UZ Antwerpen
Edegem, 2650, Belgium
UZ Leuven
Leuven, 3000, Belgium
Centre Hospitalier Universitaire de Liège
Liège, 4000, Belgium
Hospital de Amor
Barretos, 14784-400, Brazil
NewData Clinical Research - Maceió
Maceió, 57020-360, Brazil
Centro de Pesquisa Oncology Natal
Natal, 59020-400, Brazil
Centro Gaúcho Integrado de Oncologia, Hematologia, Ensino e Pesquisa
Porto Alegre, 90110-270, Brazil
CEPHO - Centro de Estudos e Pesquisas em Hematologia e Oncologia
Santo André, 09060-650, Brazil
ICESP - Instituto do Cancer do Estado de Sao Paulo
São Paulo, 01246-000, Brazil
A.C. Camargo
São Paulo, 01509-010, Brazil
Cross Cancer Institute (University of Alberta)
Edmonton, Alberta, T6G 1Z2, Canada
Princess Margaret Cancer Centre
Toronto, Ontario, M5G 2M9, Canada
Centro de Estudios Clinicos SAGA
Providencia, 7500653, Chile
Bradford Hill- Centro de Investigación Clínica
Recoleta, 8420383, Chile
China-Japan Friendship Hospital
Beijing, 100029, China
Beijing Chest Hospital, Capital Medical University
Beijing, 101149, China
The First Hospital of Jilin University
Changchun, 130000, China
Xiangya Hospital, Central South University
Changsha, 410008, China
Hunan Province Tumor Hospital
Changsha, 410013, China
Sichuan Cancer Hospital
Chengdu, 610041, China
West China Hospital, Sichuan University
Chengdu, 610041, China
The First Affiliated Hospital,Sun Yat-sen University
Guangzhou, 510080, China
The First Affiliated Hospital, Zhejiang University
Hangzhou, 310003, China
Zhejiang Cancer Hospital
Hangzhou, 310022, China
Harbin Medical University Cancer Hospital
Harbin, 150081, China
Shandong Cancer Hospital
Jinan, 250117, China
Yunnan Provincial Tumor Hospital
Kunming, 650118, China
Linyi Cancer Hospital
Linyi, 276034, China
The First Affiliated Hospital of Nanchang University
Nanchang, 330006, China
Nanjing Drum Tower Hospital
Nanjing, 210008, China
Ningbo Second Hospital
Ningbo, 315010, China
Shanghai East Hospital
Shanghai, 200121, China
Shanghai Pulmonary Hospital
Shanghai, 200433, China
Hebei Provincial Tumor Hospital
Shijiazhuang, 050035, China
The First Affiliated Hospital of Soochow University
Suzhou, 215006, China
Taizhou Hospital of Zhejiang Province
Taizhou, 317099, China
Tianjin Cancer Hospital
Tianjin, 300060, China
Tianjin Medical University General Hospital
Tianjin, 30052, China
Wuhan Union Hospital
Wuhan, 430056, China
Affiliated Hospital, Xuzhou Medical college
Xuzhou, 221009, China
Northern Jiangsu People's Hospital
Yangzhou, 225001, China
Henan Cancer Hospital
Zhengzhou, 450008, China
Sjællands Universitetshospital
Roskilde, 4000, Denmark
Hôpital Louis Pradel
Bron, 69677, France
HOP Nord
Marseille, 13915, France
HOP Nord Laennec
Nantes, 44093, France
HOP Tenon - One AP-HP
Paris, 75970, France
HOP Pontchaillou
Rennes, 35033, France
Centre Régional de Lutte Contre le Cancer Paul Stauss
Strasbourg, 67200, France
Hôpital Larrey - CHU de Toulouse
Toulouse, 31059, France
Institut Gustave Roussy
Villejuif, 94805, France
Universitätsklinikum Köln (AöR)
Cologne, 50937, Germany
Klinikum Esslingen
Esslingen am Neckar, 73730, Germany
Varisano LungenZentrum (VLZ)
Frankfurt, 65929, Germany
Asklepios Fachkliniken München-Gauting
Gauting, 82131, Germany
LungenClinic Grosshansdorf GmbH
Großhansdorf, 22927, Germany
Thoraxklinik-Heidelberg gGmbH am Universitätsklinikum Heidelberg
Heidelberg, 69126, Germany
Pius-Hospital, Oldenburg
Oldenburg, 26121, Germany
Universitätsklinikum Würzburg AÖR
Würzburg, 97078, Germany
Henry Dunant Hospital, Athens
Athens, 11526, Greece
Chest Hospital of Athens "Sotiria"
Athens, 11527, Greece
University General Hospital Attikon
Athens, 12462, Greece
Queen Elizabeth Hospital-Hong Kong-51727
Hong Kong, 51727, Hong Kong
Prince of Wales Hospital-Hong Kong-20715
Hong Kong, 999077, Hong Kong
Princess Margaret Hospital
Hong Kong, 999077, Hong Kong
Queen Mary Hospital
Hong Kong, Hong Kong
Rambam Health Care Campus
Haifa, 3109601, Israel
Shaare Zedek Medical Center, Jerusalem 91031
Jerusalem, 9103102, Israel
Meir Medical Center
Kfar Saba, 44281, Israel
Sheba Medical Center
Ramat Gan, 5262000, Israel
Sourasky Medical Center
Tel Aviv, 6093246, Israel
Istituto Tumori Giovanni Paolo II
Bari, 70124, Italy
Fondazione IRCCS Istituto Nazionale dei Tumori
Milan, 20133, Italy
Humanitas Istituto Clinico Catanese S.p.A.
Misterbianco (CT), 95045, Italy
Istituto Nazionale IRCCS Tumori Fondazione Pascale
Naples, 80131, Italy
AOU San Luigi Gonzaga
Orbassano (TO), 10043, Italy
Istituti Fisioterapici Ospitalieri
Roma, 00144, Italy
Istituto Clinico Humanitas
Rozzano (MI), 20089, Italy
Azienda Ospedaliera Universitaria Integrata Verona
Verona, 37126, Italy
Aichi Cancer Center Hospital
Aichi, Nagoya, 464-8681, Japan
Fujita Health University Hospital
Aichi, Toyoake, 470-1192, Japan
National Cancer Center Hospital East
Chiba, Kashiwa, 277-8577, Japan
Kyushu University Hospital
Fukuoka, Fukuoka, 812-8582, Japan
Hospital of the University of Occupational and Environmental Health
Fukuoka, Kitakyushu, 807-8556, Japan
Hiroshima University Hospital
Hiroshima, Hiroshima, 734-8551, Japan
Hokkaido Cancer Center
Hokkaido, Sapporo, 003-0804, Japan
Kitasato University Hospital
Kanagawa, Sagamihara, 252-0375, Japan
Kanagawa Cancer Center
Kanagawa, Yokohama, 241-8515, Japan
Sendai Kousei Hospital
Miyagi, Sendai, 981-0914, Japan
Niigata Cancer Center Hospital
Niigata, Niigata, 951-8566, Japan
Okayama University Hospital
Okayama, Okayama, 700-8558, Japan
Kansai Medical University Hospital
Osaka, Hirakata, 573-1191, Japan
Osaka International Cancer Institute
Osaka, Osaka, 541-8567, Japan
Kindai University Hospital
Osaka, Sakai, 590-0197, Japan
National Hospital Organization Kinki-Chuo Chest Medical Center
Osaka, Sakai, 591-8555, Japan
Saitama Medical University International Medical Center
Saitama, Hidaka, 350-1298, Japan
Saitama Cancer Center
Saitama, Kitaadachi-gun, 362-0806, Japan
Shizuoka Cancer Center
Shizuoka, Sunto-gun, 411-8777, Japan
Jichi Medical University Hospital
Tochigi, Shimotsuke, 329-0498, Japan
Juntendo University Hospital
Tokyo, Bunkyo-ku, 113-8431, Japan
National Cancer Center Hospital
Tokyo, Chuo-ku, 104-0045, Japan
Japanese Foundation for Cancer Research
Tokyo, Koto-ku, 135-8550, Japan
Tokyo Medical University Hospital
Tokyo, Shinjuku-ku, 160-0023, Japan
Wakayama Medical University Hospital
Wakayama, Wakayama, 641-8510, Japan
Centro Oncologico Internacional
Jalisco, 45640, Mexico
Centro de Infusion Profesional Integral (CIPI)
Mexico City, 14210, Mexico
Centro Oncologico Personalizado
México, 06760, Mexico
Instituto Nacional de Cancerologia
México, 14080, Mexico
Centro Medico Zambrano Hellion
Monterrey, 66278, Mexico
Nederlands Kanker Instituut - Antoni van Leeuwenhoek Amsterdam (METC AVL)
Amsterdam, 1066CX, Netherlands
Hospital CUF Tejo
Lisbon, 1350-352, Portugal
Hospital da Luz
Lisbon, 1500-650, Portugal
Hospital CUF Porto
Porto, 4100-180, Portugal
IPO Porto Francisco Gentil, EPE
Porto, 4200-072, Portugal
Lotus Med
Bucharest, 012292, Romania
Memorial Healthcare International
Bucharest, 013823, Romania
Ovidius Clinical Hospital S.R.L
Ovidiu, 905900, Romania
Polaris Medical S.A.
Suceagu/ Cluj Napoca, 407062, Romania
National Cancer Centre Singapore
Singapore, 168583, Singapore
National Cancer Center
Goyang, 10408, South Korea
Seoul National University Bundang Hospital
Seongnam, 13620, South Korea
Seoul National University Hospital
Seoul, 03080, South Korea
Severance Hospital
Seoul, 03722, South Korea
Asan Medical Center
Seoul, 05505, South Korea
Samsung Medical Center
Seoul, 06351, South Korea
The Catholic University of Korea, St.Vincent's Hospital
Suwon, 16247, South Korea
Ajou University Hospital
Suwon, 16499, South Korea
Hospital del Mar
Barcelona, 08003, Spain
Hospital Universitari Vall D Hebron
Barcelona, 08035, Spain
Hospital Universitario De Burgos
Burgos, 09006, Spain
Hospital General Universitario de Elche
Elche, 03203, Spain
Hospital Jerez de la Frontera
Jerez de la Frontera, 11407, Spain
Hospital Duran i Reynals
L'Hospitalet de Llobregat, 08908, Spain
Hospital Universitario Ramon Y Cajal
Madrid, 28034, Spain
Fundación Jiménez Díaz
Madrid, 28040, Spain
Hospital Universitario 12 de Octubre
Madrid, 28041, Spain
Hospital Puerta de Hierro
Majadahonda, 28222, Spain
Hospital Universitario Virgen de la Victoria
Málaga, 29010, Spain
Complejo Hospitalario de Navarra
Pamplona, 31008, Spain
Salut Sant Joan de Reus
Reus, 43204, Spain
Hospital Virgen del Rocío
Seville, 41013, Spain
Hospital Clinico Universitario de Valencia
Valencia, 46010, Spain
Sahlgrenska Universitetsjukhuset
Gothenburg, 413 46, Sweden
Karolinska Universitetssjukhuset Solna
Stockholm, 171 76, Sweden
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, 807, Taiwan
China Medical University Hospital
Taichung, 40447, Taiwan
National Taiwan University Hospital
Taipei, 10048, Taiwan
Taipei Veterans General Hospital
Taipei, 11217, Taiwan
Tri-Service General Hospital
Taipei, 114, Taiwan
Chang Gung Memorial Hospital, Linkou
Taoyuan City, 333, Taiwan
Sağlık Bilimleri Üniversitesi Gülhane Eğitim ve Araştırma Hastanesi
Ankara, 06018, Turkey (Türkiye)
Medeniyet University
Istanbul, 34862, Turkey (Türkiye)
Velindre Cancer Centre
Cardiff, CF14 2TL, United Kingdom
Western General Hospital
Edinburgh, EH4 2XU, United Kingdom
Guy's Hospital
London, SE1 9RT, United Kingdom
The Royal Marsden Hospital, Chelsea
London, SW3 6JJ, United Kingdom
The Christie
Manchester, M20 4BX, United Kingdom
The Royal Marsden Hospital, Sutton
Sutton, SM2 5PT, United Kingdom
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 25, 2025
First Posted
September 29, 2025
Study Start
January 16, 2026
Primary Completion (Estimated)
February 26, 2032
Study Completion (Estimated)
September 2, 2036
Last Updated
June 1, 2026
Record last verified: 2026-05
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- One year after the approval has been granted by major Regulatory Authorities and after the primary manuscript has been accepted for publication, or after termination of the development program.
- Access Criteria
- For study documents - upon signing of a "Document Sharing Agreement". For study data - 1. after the submission and approval of the research proposal (checks will be performed by the sponsor and/or the independent review panel, including checking that the planned analysis does not compete with sponsor's publication plan); 2. and upon signing of a legal agreement.
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.