RecruitingRecruiting
Beamion LUNG-3: Adjuvant Zongertinib vs Standard Treatment in People With Completely Resected Stage II-IIIB NSCLC Harboring Activating HER2 TKD Mutations
NCT07195695 · Boehringer Ingelheim
In plain English
Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.
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
About this study
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.
Eligibility criteria
Inclusion criteria:
1. Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial
2. Patients must be ≥18 years old or over the legal age of consent in their country
3. 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
4. HER2 mutation: Documented Tyrosine kinase domain (TKD) activating Human epidermal growth factor receptor 2 (HER2) mutations
5. Histology and tumor sample: Histologically confirmed diagnosis of primary NSCLC
6. An archival tumor tissue sample must be submitted to the central laboratory after inclusion of the patient to retrospectively confirm the HER2 status
7. Staging: Pretherapeutic classification not exceeding Stage IIIB
8. 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.
Exclusion criteria:
1. Diagnosis of NSCLC with mixed histology/positive neuroendocrine markers (synaptophysin/CD56)
2. Major surgery (major according to the investigator's assessment) performed within 4 weeks prior to randomization
3. Treatment with radiation therapy for primary NSCLC
4. Co-occurring actionable mutation with approved targeted therapy (e.g. Epidermal growth factor receptor (EGFR) or Anaplastic lymphoma kinase (ALK))
5. Any investigational drug within 5 half-lives of the compound or any of its related material, if known
6. 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
* 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.
Study design
Enrollment target: 400 participants
Allocation: randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2026-01-16
Estimated completion: 2036-09-02
Last updated: 2026-06-01
Interventions
Drug: ZongertinibDrug: PembrolizumabDrug: AtezolizumabDrug: DurvalumabDrug: Nivolumab
Primary outcomes
- • Disease-free survival (DFS) by investigator's assessment (up to 8 years and 5 months)
Sponsor
Boehringer Ingelheim · industry
Contacts & investigators
ContactBoehringer Ingelheim · contact · clintriage.rdg@boehringer-ingelheim.com · 1-800-243-0127
All locations (199)
ClinRé 001-022 (Premier Cancer Care and Infusion Center)Recruiting
Fresno, California, United States
OPN Healthcare, Inc.Recruiting
Glendale, California, United States
University of California IrvineNot Yet Recruiting
Irvine, California, United States
Sutter HealthNot Yet Recruiting
Roseville, California, United States
University of California San FranciscoNot Yet Recruiting
San Francisco, California, United States
Sarcoma Oncology CenterNot Yet Recruiting
Santa Monica, California, United States
University of California Los AngelesRecruiting
Santa Monica, California, United States
Northern California Kaiser PermanenteNot Yet Recruiting
Vallejo, California, United States
George Washington University Cancer CenterNot Yet Recruiting
Washington D.C., District of Columbia, United States
Mid Florida Hematology and Oncology CenterRecruiting
Orange City, Florida, United States
Piedmont Cancer InstituteRecruiting
Atlanta, Georgia, United States
Northwest Georgia Oncology CentersRecruiting
Marietta, Georgia, United States
Saint Alphonsus Regional Medical Center - BoiseNot Yet Recruiting
Boise, Idaho, United States
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Chicago, Illinois, United States
University of Illinois Hospital and Health Sciences SystemRecruiting
Chicago, Illinois, United States
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Lisle, Illinois, United States
Dana-Farber Cancer InstituteRecruiting
Boston, Massachusetts, United States
Cancer Care SpecialistsRecruiting
Reno, Nevada, United States
Dartmouth-Hitchcock Medical CenterNot Yet Recruiting
Lebanon, New Hampshire, United States
Laura & Isaac Perlmutter Cancer Center at NYU Langone HealthRecruiting
New York, New York, United States
Memorial Sloan-Kettering Cancer CenterRecruiting
New York, New York, United States
Levine Cancer InstituteNot Yet Recruiting
Charlotte, North Carolina, United States
Durham VA Health Care SystemNot Yet Recruiting
Durham, North Carolina, United States
Providence Cancer InstituteRecruiting
Portland, Oregon, United States
Providence Cancer InstituteNot Yet Recruiting
Portland, Oregon, United States
Hendrick HealthRecruiting
Abilene, Texas, United States
The University of Texas MD Anderson Cancer CenterNot Yet Recruiting
Houston, Texas, United States
Community Cancer Trials of UtahRecruiting
Ogden, Utah, United States
Virginia Cancer Specialists, PCNot Yet Recruiting
Fairfax, Virginia, United States
Centro de Investigaciones Médicas y Desarrollo LC S.R.L. (LC Investigación)Recruiting
CABA, Argentina
Hospital Britanico de Buenos AiresRecruiting
CABA, Argentina
Centro Oncologico KorbenRecruiting
CABA, Argentina
Clinica Adventista BelgranoRecruiting
CABA, Argentina
Instituto Medico Especializado Alexander FlemingNot Yet Recruiting
Capital Federal, Argentina
Royal North Shore HospitalNot Yet Recruiting
Sydney, New South Wales, Australia
Princess Alexandra HospitalNot Yet Recruiting
Woolloongabba, Queensland, Australia
Flinders Medical CentreNot Yet Recruiting
Bedford Park, South Australia, Australia
Austin HealthNot Yet Recruiting
Heidelberg, Victoria, Australia
St John of God Subiaco HospitalRecruiting
Subiaco, Western Australia, Australia
Medical University of InnsbruckNot Yet Recruiting
Innsbruck, Austria
Clinic FloridsdorfNot Yet Recruiting
Vienna, Austria
Edegem - UNIV UZ AntwerpenRecruiting
Edegem, Belgium
UZ LeuvenRecruiting
Leuven, Belgium
Centre Hospitalier Universitaire de LiègeNot Yet Recruiting
Liège, Belgium
Hospital de AmorRecruiting
Barretos, Brazil
NewData Clinical Research - MaceióNot Yet Recruiting
Maceió, Brazil
Centro de Pesquisa Oncology NatalRecruiting
Natal, Brazil
Centro Gaúcho Integrado de Oncologia, Hematologia, Ensino e PesquisaRecruiting
Porto Alegre, Brazil
CEPHO - Centro de Estudos e Pesquisas em Hematologia e OncologiaRecruiting
Santo André, Brazil
ICESP - Instituto do Cancer do Estado de Sao PauloNot Yet Recruiting
São Paulo, Brazil
A.C. CamargoRecruiting
São Paulo, Brazil
Cross Cancer Institute (University of Alberta)Not Yet Recruiting
Edmonton, Alberta, Canada
Princess Margaret Cancer CentreNot Yet Recruiting
Toronto, Ontario, Canada
Centro de Estudios Clinicos SAGANot Yet Recruiting
Providencia, Chile
Bradford Hill- Centro de Investigación ClínicaNot Yet Recruiting
Recoleta, Chile
China-Japan Friendship HospitalRecruiting
Beijing, China
Beijing Chest Hospital, Capital Medical UniversityRecruiting
Beijing, China
The First Hospital of Jilin UniversityRecruiting
Changchun, China
Xiangya Hospital, Central South UniversityNot Yet Recruiting
Changsha, China
Hunan Province Tumor HospitalNot Yet Recruiting
Changsha, China
Sichuan Cancer HospitalRecruiting
Chengdu, China
West China Hospital, Sichuan UniversityRecruiting
Chengdu, China
The First Affiliated Hospital,Sun Yat-sen UniversityRecruiting
Guangzhou, China
The First Affiliated Hospital, Zhejiang UniversityRecruiting
Hangzhou, China
Zhejiang Cancer HospitalNot Yet Recruiting
Hangzhou, China
Harbin Medical University Cancer HospitalRecruiting
Harbin, China
Shandong Cancer HospitalRecruiting
Jinan, China
Yunnan Provincial Tumor HospitalNot Yet Recruiting
Kunming, China
Linyi Cancer HospitalRecruiting
Linyi, China
The First Affiliated Hospital of Nanchang UniversityRecruiting
Nanchang, China
Nanjing Drum Tower HospitalRecruiting
Nanjing, China
Ningbo Second HospitalRecruiting
Ningbo, China
Shanghai East HospitalRecruiting
Shanghai, China
Shanghai Pulmonary HospitalRecruiting
Shanghai, China
Hebei Provincial Tumor HospitalNot Yet Recruiting
Shijiazhuang, China
The First Affiliated Hospital of Soochow UniversityRecruiting
Suzhou, China
Taizhou Hospital of Zhejiang ProvinceRecruiting
Taizhou, China
Tianjin Cancer HospitalRecruiting
Tianjin, China
Tianjin Medical University General HospitalRecruiting
Tianjin, China
Wuhan Union HospitalRecruiting
Wuhan, China
Affiliated Hospital, Xuzhou Medical collegeRecruiting
Xuzhou, China
Northern Jiangsu People's HospitalRecruiting
Yangzhou, China
Henan Cancer HospitalNot Yet Recruiting
Zhengzhou, China
Sjællands UniversitetshospitalNot Yet Recruiting
Roskilde, Denmark
Hôpital Louis PradelRecruiting
Bron, France
HOP NordRecruiting
Marseille, France
HOP Nord LaennecRecruiting
Nantes, France
HOP Tenon - One AP-HPNot Yet Recruiting
Paris, France
HOP PontchaillouRecruiting
Rennes, France
Centre Régional de Lutte Contre le Cancer Paul StaussRecruiting
Strasbourg, France
Hôpital Larrey - CHU de ToulouseRecruiting
Toulouse, France
Institut Gustave RoussyNot Yet Recruiting
Villejuif, France
Universitätsklinikum Köln (AöR)Not Yet Recruiting
Cologne, Germany
Klinikum EsslingenRecruiting
Esslingen am Neckar, Germany
Varisano LungenZentrum (VLZ)Not Yet Recruiting
Frankfurt, Germany
Asklepios Fachkliniken München-GautingNot Yet Recruiting
Gauting, Germany
LungenClinic Grosshansdorf GmbHRecruiting
Großhansdorf, Germany
Thoraxklinik-Heidelberg gGmbH am Universitätsklinikum HeidelbergRecruiting
Heidelberg, Germany
Pius-Hospital, OldenburgRecruiting
Oldenburg, Germany
Universitätsklinikum Würzburg AÖRRecruiting
Würzburg, Germany
Henry Dunant Hospital, AthensNot Yet Recruiting
Athens, Greece
Chest Hospital of Athens "Sotiria"Not Yet Recruiting
Athens, Greece
University General Hospital AttikonNot Yet Recruiting
Athens, Greece
Queen Elizabeth Hospital-Hong Kong-51727Recruiting
Hong Kong, Hong Kong
Prince of Wales Hospital-Hong Kong-20715Recruiting
Hong Kong, Hong Kong
Princess Margaret HospitalRecruiting
Hong Kong, Hong Kong
Queen Mary HospitalRecruiting
Hong Kong, Hong Kong
Rambam Health Care CampusNot Yet Recruiting
Haifa, Israel
Shaare Zedek Medical Center, Jerusalem 91031Not Yet Recruiting
Jerusalem, Israel
Meir Medical CenterNot Yet Recruiting
Kfar Saba, Israel
Sheba Medical CenterNot Yet Recruiting
Ramat Gan, Israel
Sourasky Medical CenterNot Yet Recruiting
Tel Aviv, Israel
Istituto Tumori Giovanni Paolo IINot Yet Recruiting
Bari, Italy
Fondazione IRCCS Istituto Nazionale dei TumoriNot Yet Recruiting
Milan, Italy
Humanitas Istituto Clinico Catanese S.p.A.Not Yet Recruiting
Misterbianco (CT), Italy
Istituto Nazionale IRCCS Tumori Fondazione PascaleRecruiting
Naples, Italy
AOU San Luigi GonzagaNot Yet Recruiting
Orbassano (TO), Italy
Istituti Fisioterapici OspitalieriRecruiting
Roma, Italy
Istituto Clinico HumanitasNot Yet Recruiting
Rozzano (MI), Italy
Azienda Ospedaliera Universitaria Integrata VeronaNot Yet Recruiting
Verona, Italy
Aichi Cancer Center HospitalRecruiting
Aichi, Nagoya, Japan
Fujita Health University HospitalRecruiting
Aichi, Toyoake, Japan
National Cancer Center Hospital EastNot Yet Recruiting
Chiba, Kashiwa, Japan
Kyushu University HospitalRecruiting
Fukuoka, Fukuoka, Japan
Hospital of the University of Occupational and Environmental HealthRecruiting
Fukuoka, Kitakyushu, Japan
Hiroshima University HospitalRecruiting
Hiroshima, Hiroshima, Japan
Hokkaido Cancer CenterRecruiting
Hokkaido, Sapporo, Japan
Kitasato University HospitalRecruiting
Kanagawa, Sagamihara, Japan
Kanagawa Cancer CenterRecruiting
Kanagawa, Yokohama, Japan
Sendai Kousei HospitalRecruiting
Miyagi, Sendai, Japan
Niigata Cancer Center HospitalRecruiting
Niigata, Niigata, Japan
Okayama University HospitalRecruiting
Okayama, Okayama, Japan
Kansai Medical University HospitalRecruiting
Osaka, Hirakata, Japan
Osaka International Cancer InstituteRecruiting
Osaka, Osaka, Japan
Kindai University HospitalRecruiting
Osaka, Sakai, Japan
National Hospital Organization Kinki-Chuo Chest Medical CenterRecruiting
Osaka, Sakai, Japan
Saitama Medical University International Medical CenterRecruiting
Saitama, Hidaka, Japan
Saitama Cancer CenterRecruiting
Saitama, Kitaadachi-gun, Japan
Shizuoka Cancer CenterRecruiting
Shizuoka, Sunto-gun, Japan
Jichi Medical University HospitalRecruiting
Tochigi, Shimotsuke, Japan
Juntendo University HospitalRecruiting
Tokyo, Bunkyo-ku, Japan
National Cancer Center HospitalNot Yet Recruiting
Tokyo, Chuo-ku, Japan
Japanese Foundation for Cancer ResearchRecruiting
Tokyo, Koto-ku, Japan
Tokyo Medical University HospitalRecruiting
Tokyo, Shinjuku-ku, Japan
Wakayama Medical University HospitalRecruiting
Wakayama, Wakayama, Japan
Centro Oncologico InternacionalNot Yet Recruiting
Jalisco, Mexico
Centro de Infusion Profesional Integral (CIPI)Not Yet Recruiting
Mexico City, Mexico
Centro Oncologico PersonalizadoNot Yet Recruiting
México, Mexico
Instituto Nacional de CancerologiaNot Yet Recruiting
México, Mexico
Centro Medico Zambrano HellionNot Yet Recruiting
Monterrey, Mexico
Nederlands Kanker Instituut - Antoni van Leeuwenhoek Amsterdam (METC AVL)Not Yet Recruiting
Amsterdam, Netherlands
Hospital CUF TejoRecruiting
Lisbon, Portugal
Hospital da LuzRecruiting
Lisbon, Portugal
Hospital CUF PortoRecruiting
Porto, Portugal
IPO Porto Francisco Gentil, EPENot Yet Recruiting
Porto, Portugal
Lotus MedRecruiting
Bucharest, Romania
Memorial Healthcare InternationalRecruiting
Bucharest, Romania
Ovidius Clinical Hospital S.R.LRecruiting
Ovidiu, Romania
Polaris Medical S.A.Not Yet Recruiting
Suceagu/ Cluj Napoca, Romania
National Cancer Centre SingaporeRecruiting
Singapore, Singapore
National Cancer CenterRecruiting
Goyang, South Korea
Seoul National University Bundang HospitalRecruiting
Seongnam, South Korea
Seoul National University HospitalRecruiting
Seoul, South Korea
Severance HospitalRecruiting
Seoul, South Korea
Asan Medical CenterRecruiting
Seoul, South Korea
Samsung Medical CenterRecruiting
Seoul, South Korea
The Catholic University of Korea, St.Vincent's HospitalRecruiting
Suwon, South Korea
Ajou University HospitalRecruiting
Suwon, South Korea
Hospital del MarRecruiting
Barcelona, Spain
Hospital Universitari Vall D HebronRecruiting
Barcelona, Spain
Hospital Universitario De BurgosRecruiting
Burgos, Spain
Hospital General Universitario de ElcheNot Yet Recruiting
Elche, Spain
Hospital Jerez de la FronteraRecruiting
Jerez de la Frontera, Spain
Hospital Duran i ReynalsNot Yet Recruiting
L'Hospitalet de Llobregat, Spain
Hospital Universitario Ramon Y CajalRecruiting
Madrid, Spain
Fundación Jiménez DíazRecruiting
Madrid, Spain
Hospital Universitario 12 de OctubreRecruiting
Madrid, Spain
Hospital Puerta de HierroNot Yet Recruiting
Majadahonda, Spain
Hospital Universitario Virgen de la VictoriaRecruiting
Málaga, Spain
Complejo Hospitalario de NavarraRecruiting
Pamplona, Spain
Salut Sant Joan de ReusRecruiting
Reus, Spain
Hospital Virgen del RocíoRecruiting
Seville, Spain
Hospital Clinico Universitario de ValenciaRecruiting
Valencia, Spain
Sahlgrenska UniversitetsjukhusetRecruiting
Gothenburg, Sweden
Karolinska Universitetssjukhuset SolnaRecruiting
Stockholm, Sweden
Kaohsiung Medical University Chung-Ho Memorial HospitalRecruiting
Kaohsiung City, Taiwan
China Medical University HospitalRecruiting
Taichung, Taiwan
National Taiwan University HospitalRecruiting
Taipei, Taiwan
Taipei Veterans General HospitalRecruiting
Taipei, Taiwan
Tri-Service General HospitalNot Yet Recruiting
Taipei, Taiwan
Chang Gung Memorial Hospital, LinkouRecruiting
Taoyuan City, Taiwan
Sağlık Bilimleri Üniversitesi Gülhane Eğitim ve Araştırma HastanesiNot Yet Recruiting
Ankara, Turkey (Türkiye)
Medeniyet UniversityNot Yet Recruiting
Istanbul, Turkey (Türkiye)
Velindre Cancer CentreNot Yet Recruiting
Cardiff, United Kingdom
Western General HospitalRecruiting
Edinburgh, United Kingdom
Guy's HospitalNot Yet Recruiting
London, United Kingdom
The Royal Marsden Hospital, ChelseaRecruiting
London, United Kingdom
The ChristieRecruiting
Manchester, United Kingdom
The Royal Marsden Hospital, SuttonRecruiting
Sutton, United Kingdom