Ignite Creation Date:
2025-12-24 @ 1:30 PM
Ignite Modification Date:
2025-12-30 @ 5:08 AM
Study NCT ID:
NCT07195695
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-12-22
First Post:
2025-09-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Beamion LUNG-3: A Study to Test Whether Zongertinib Helps People With Surgically Removed, Non-small Cell Lung Cancer With HER2 Mutations Compared With Standard Treatment
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002289', 'term': 'Carcinoma, Non-Small-Cell Lung'}], 'ancestors': [{'id': 'D002283', 'term': 'Carcinoma, Bronchogenic'}, {'id': 'D001984', 'term': 'Bronchial Neoplasms'}, {'id': 'D008175', 'term': 'Lung Neoplasms'}, {'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C582435', 'term': 'pembrolizumab'}, {'id': 'C000594389', 'term': 'atezolizumab'}, {'id': 'C000613593', 'term': 'durvalumab'}, {'id': 'D000077594', 'term': 'Nivolumab'}], 'ancestors': [{'id': 'D061067', 'term': 'Antibodies, Monoclonal, Humanized'}, {'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 400}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-12-29', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2036-09-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-19', 'studyFirstSubmitDate': '2025-09-25', 'studyFirstSubmitQcDate': '2025-09-25', 'lastUpdatePostDateStruct': {'date': '2025-12-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-09-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2032-02-26', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Disease-free survival (DFS) by investigator's assessment", 'timeFrame': 'up to 8 years and 5 months', 'description': 'DFS is defined as the time from randomization until recurrence of tumor or death from any cause, whichever occurs earlier'}], 'secondaryOutcomes': [{'measure': 'Key secondary endpoint: Overall survival (OS), defined as the time from randomization until death from any cause', 'timeFrame': 'up to 8 years and 5 months'}, {'measure': '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', 'timeFrame': 'up to 3 years', 'description': 'AEs are graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 5.0'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Non-small Cell Lung Cancer']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.mystudywindow.com', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': "This study is open to adults 18 years and older who have early-stage non-small cell lung cancer (NSCLC). Their cancer must have a specific change in a gene called HER2. Genes provide the instructions for making proteins, and this change leads to a faulty HER2 protein. People can join if their lung cancer was removed by surgery, and they have already received certain other anti-cancer treatments. The purpose of this study is to find out if a study medicine called zongertinib helps people with this type of cancer live longer without their cancer coming back after surgery, when compared to standard treatment. Zongertinib is being developed to target the faulty HER2 protein, which can cause cancer cells to grow.\n\nIn this study, participants are assigned by chance to one of two treatment groups, with an equal chance of being in either group. One group takes the study medicine, zongertinib, by mouth once a day for up to 3 years. The other group receives a standard treatment, chosen by their doctor. This standard treatment may be an immunotherapy medicine given by infusion into a vein every 3 or 4 weeks for up to 1 year, or regular check-ups without active study medicine (observation).\n\nParticipants can be in this study for up to about 11 years. During this time, they visit the study site regularly for check-ups and study-related tests. The frequency of these visits varies depending on their treatment and how long they have been in the study. In addition to visits at the study site, participants in some treatment groups will also have phone calls with the study team every 3 weeks to check on their health between their scheduled visits.\n\nDoctors check for any signs of cancer coming back using imaging scans (like CT or MRI scans); these scans are generally done every 3 months for the first 2 years, then every 6 months for the next 3 years, and then yearly. Participants also fill in questionnaires about their overall wellbeing, health and symptoms. Throughout the study, doctors also check participants' health and note any unwanted effects."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion criteria:\n\n1. Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial\n2. Patients must be ≥18 years old or over the legal age of consent in their country\n3. 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\n4. HER2 mutation: Documented Tyrosine kinase domain (TKD) activating Human epidermal growth factor receptor 2 (HER2) mutations\n5. Histology and tumor sample: Histologically confirmed diagnosis of primary NSCLC\n6. An archival tumor tissue sample must be submitted to the central laboratory after inclusion of the patient to retrospectively confirm the HER2 status\n7. Staging: Pretherapeutic classification not exceeding Stage IIIB\n8. Performance status and organ function:\n\n * Eastern Cooperative Oncology Group (ECOG) score of 0 or 1\n * Adequate organ function based on laboratory values Further inclusion criteria apply.\n\nExclusion criteria:\n\n1. Diagnosis of NSCLC with mixed histology/positive neuroendocrine markers (synaptophysin/CD56)\n2. Major surgery (major according to the investigator's assessment) performed within 4 weeks prior to randomization\n3. Treatment with radiation therapy for primary NSCLC\n4. Co-occurring actionable mutation with approved targeted therapy (e.g. Epidermal growth factor receptor (EGFR) or Anaplastic lymphoma kinase (ALK))\n5. Any investigational drug within 5 half-lives of the compound or any of its related material, if known\n6. History or presence of\n\n * Active or known pre-existing or history of non-infectious interstitial lung disease/pneumonitis\n * Active infectious disease requiring systemic therapy\n * Uncontrolled gastrointestinal disorders affecting drug intake/absorption\n * Previous or concomitant malignancies within the last 3 years, except certain effectively treated cancers\n * 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."}, 'identificationModule': {'nctId': 'NCT07195695', 'briefTitle': 'Beamion LUNG-3: A Study to Test Whether Zongertinib Helps People With Surgically Removed, Non-small Cell Lung Cancer With HER2 Mutations Compared With Standard Treatment', 'organization': {'class': 'INDUSTRY', 'fullName': 'Boehringer Ingelheim'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': '1479-0032'}, 'secondaryIdInfos': [{'id': 'U1111-1320-6149', 'type': 'REGISTRY', 'domain': 'WHO - International Clinical Trials Registry Platform (ICTRP)'}, {'id': '2025-521284-12-00', 'type': 'CTIS'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Zongertinib treatment arm', 'interventionNames': ['Drug: Zongertinib']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Standard of Care (SoC) treatment arm', 'interventionNames': ['Drug: Pembrolizumab', 'Drug: Atezolizumab', 'Drug: Durvalumab', 'Drug: Nivolumab']}], 'interventions': [{'name': 'Zongertinib', 'type': 'DRUG', 'otherNames': ['BI 1810631, Hernexeos®'], 'description': 'Zongertinib', 'armGroupLabels': ['Zongertinib treatment arm']}, {'name': 'Pembrolizumab', 'type': 'DRUG', 'description': 'Pembrolizumab', 'armGroupLabels': ['Standard of Care (SoC) treatment arm']}, {'name': 'Atezolizumab', 'type': 'DRUG', 'description': 'Atezolizumab', 'armGroupLabels': ['Standard of Care (SoC) treatment arm']}, {'name': 'Durvalumab', 'type': 'DRUG', 'description': 'Durvalumab', 'armGroupLabels': ['Standard of Care (SoC) treatment arm']}, {'name': 'Nivolumab', 'type': 'DRUG', 'description': 'Nivolumab', 'armGroupLabels': ['Standard of Care (SoC) treatment arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '93720', 'city': 'Fresno', 'state': 'California', 'country': 'United States', 'contacts': [{'name': 'Boehringer Ingelheim', 'role': 'CONTACT', 'email': 'unitedstates@bitrialsupport.com', 'phone': '833-602-2368'}], 'facility': 'Premier Cancer Care', 'geoPoint': {'lat': 36.74773, 'lon': -119.77237}}, {'zip': '91203', 'city': 'Glendale', 'state': 'California', 'country': 'United States', 'contacts': [{'name': 'Boehringer Ingelheim', 'role': 'CONTACT', 'email': 'unitedstates@bitrialsupport.com', 'phone': '833-602-2368'}], 'facility': 'OPN Healthcare, Inc.', 'geoPoint': {'lat': 34.14251, 'lon': -118.25508}}, {'zip': '95661', 'city': 'Roseville', 'state': 'California', 'country': 'United States', 'contacts': [{'name': 'Boehringer Ingelheim', 'role': 'CONTACT', 'email': 'unitedstates@bitrialsupport.com', 'phone': '833-602-2368'}], 'facility': 'Sutter Health', 'geoPoint': {'lat': 38.75212, 'lon': -121.28801}}, {'zip': '90404', 'city': 'Santa Monica', 'state': 'California', 'country': 'United States', 'contacts': [{'name': 'Boehringer Ingelheim', 'role': 'CONTACT', 'email': 'unitedstates@bitrialsupport.com', 'phone': '833-602-2368'}], 'facility': 'University of California Los Angeles', 'geoPoint': {'lat': 34.01949, 'lon': -118.49138}}, {'zip': '94589', 'city': 'Vallejo', 'state': 'California', 'country': 'United States', 'contacts': [{'name': 'Boehringer Ingelheim', 'role': 'CONTACT', 'email': 'unitedstates@bitrialsupport.com', 'phone': '833-602-2368'}], 'facility': 'Northern California Kaiser Permanente', 'geoPoint': {'lat': 38.10409, 'lon': -122.25664}}, {'zip': '20037', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'contacts': [{'name': 'Boehringer Ingelheim', 'role': 'CONTACT', 'email': 'unitedstates@bitrialsupport.com', 'phone': '833-602-2368'}], 'facility': 'George Washington University Cancer Center', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'zip': '32763', 'city': 'Orange City', 'state': 'Florida', 'country': 'United States', 'contacts': [{'name': 'Boehringer Ingelheim', 'role': 'CONTACT', 'email': 'unitedstates@bitrialsupport.com', 'phone': '833-602-2368'}], 'facility': 'Mid Florida Hematology and Oncology Center', 'geoPoint': {'lat': 28.94888, 'lon': -81.29867}}, {'zip': '30318', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'contacts': [{'name': 'Boehringer Ingelheim', 'role': 'CONTACT', 'email': 'unitedstates@bitrialsupport.com', 'phone': '833-602-2368'}], 'facility': 'Piedmont Cancer Institute', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '30060', 'city': 'Marietta', 'state': 'Georgia', 'country': 'United States', 'contacts': [{'name': 'Boehringer Ingelheim', 'role': 'CONTACT', 'email': 'unitedstates@bitrialsupport.com', 'phone': '833-602-2368'}], 'facility': 'Northwest Georgia Oncology Centers', 'geoPoint': {'lat': 33.9526, 'lon': -84.54993}}, {'zip': '83706', 'city': 'Boise', 'state': 'Idaho', 'country': 'United States', 'contacts': [{'name': 'Boehringer Ingelheim', 'role': 'CONTACT', 'email': 'unitedstates@bitrialsupport.com', 'phone': '833-602-2368'}], 'facility': 'Saint Alphonsus Regional Medical Center - 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(LC Investigación)'}, {'zip': '1280AEB', 'city': 'CABA', 'country': 'Argentina', 'contacts': [{'name': 'Boehringer Ingelheim', 'role': 'CONTACT', 'email': 'argentina@bitrialsupport.com', 'phone': '08002667801'}], 'facility': 'Hospital Britanico de Buenos Aires'}, {'zip': '1426', 'city': 'CABA', 'country': 'Argentina', 'contacts': [{'name': 'Boehringer Ingelheim', 'role': 'CONTACT', 'email': 'argentina@bitrialsupport.com', 'phone': '08002667801'}], 'facility': 'Centro Oncologico Korben'}, {'zip': '1430', 'city': 'CABA', 'country': 'Argentina', 'contacts': [{'name': 'Boehringer Ingelheim', 'role': 'CONTACT', 'email': 'argentina@bitrialsupport.com', 'phone': '08002667801'}], 'facility': 'Clinica Adventista Belgrano'}, {'zip': 'C1426ANZ', 'city': 'Capital Federal', 'country': 'Argentina', 'contacts': [{'name': 'Boehringer Ingelheim', 'role': 'CONTACT', 'email': 'argentina@bitrialsupport.com', 'phone': '08002667801'}], 'facility': 'Instituto Medico Especializado Alexander Fleming'}, {'zip': '1210', 'city': 'Vienna', 'country': 'Austria', 'contacts': [{'name': 'Boehringer Ingelheim', 'role': 'CONTACT', 'email': 'oesterreich@bitrialsupport.com', 'phone': '0800017900'}], 'facility': 'Clinic Floridsdorf', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}, {'zip': '2650', 'city': 'Edegem', 'country': 'Belgium', 'contacts': [{'name': 'Boehringer Ingelheim', 'role': 'CONTACT', 'email': 'belgique@bitrialsupport.com', 'phone': '080049616'}], 'facility': 'Edegem - UNIV UZ Antwerpen', 'geoPoint': {'lat': 51.15662, 'lon': 4.44504}}, {'zip': '3000', 'city': 'Leuven', 'country': 'Belgium', 'contacts': [{'name': 'Boehringer Ingelheim', 'role': 'CONTACT', 'email': 'belgique@bitrialsupport.com', 'phone': '080049616'}], 'facility': 'UZ Leuven', 'geoPoint': {'lat': 50.87959, 'lon': 4.70093}}, {'zip': '4000', 'city': 'Liège', 'country': 'Belgium', 'contacts': [{'name': 'Boehringer Ingelheim', 'role': 'CONTACT', 'email': 'belgique@bitrialsupport.com', 'phone': '080049616'}], 'facility': 'Centre Hospitalier Universitaire de Liège', 'geoPoint': {'lat': 50.63373, 'lon': 5.56749}}, {'zip': '14784-400', 'city': 'Barretos', 'country': 'Brazil', 'contacts': [{'name': 'Boehringer Ingelheim', 'role': 'CONTACT', 'email': 'brasil@bitrialsupport.com', 'phone': '08008919295'}], 'facility': 'Hospital de Amor', 'geoPoint': {'lat': -20.55722, 'lon': -48.56778}}, {'zip': '57020-360', 'city': 'Maceió', 'country': 'Brazil', 'contacts': [{'name': 'Boehringer Ingelheim', 'role': 'CONTACT', 'email': 'brasil@bitrialsupport.com', 'phone': '08008919295'}], 'facility': 'NewData Clinical Research - Maceió', 'geoPoint': {'lat': -9.66583, 'lon': -35.73528}}, {'zip': '59020-400', 'city': 'Natal', 'country': 'Brazil', 'contacts': [{'name': 'Boehringer Ingelheim', 'role': 'CONTACT', 'email': 'brasil@bitrialsupport.com', 'phone': '08008919295'}], 'facility': 'Centro de Pesquisa Oncology Natal', 'geoPoint': {'lat': -5.795, 'lon': -35.20944}}, {'zip': '90110-270', 'city': 'Porto Alegre', 'country': 'Brazil', 'contacts': [{'name': 'Boehringer Ingelheim', 'role': 'CONTACT', 'email': 'brasil@bitrialsupport.com', 'phone': '08008919295'}], 'facility': 'Centro Gaúcho Integrado de Oncologia, Hematologia, Ensino e Pesquisa', 'geoPoint': {'lat': -30.03283, 'lon': -51.23019}}, {'zip': '09060-650', 'city': 'Santo André', 'country': 'Brazil', 'contacts': [{'name': 'Boehringer Ingelheim', 'role': 'CONTACT', 'email': 'brasil@bitrialsupport.com', 'phone': '08008919295'}], 'facility': 'CEPHO - Centro de Estudos e Pesquisas em Hematologia e Oncologia', 'geoPoint': {'lat': -23.66389, 'lon': -46.53833}}, {'zip': '01246-000', 'city': 'São Paulo', 'country': 'Brazil', 'contacts': [{'name': 'Boehringer Ingelheim', 'role': 'CONTACT', 'email': 'brasil@bitrialsupport.com', 'phone': '08008919295'}], 'facility': 'ICESP - Instituto do Cancer do Estado de Sao Paulo', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}, {'zip': '01509-010', 'city': 'São Paulo', 'country': 'Brazil', 'contacts': [{'name': 'Boehringer Ingelheim', 'role': 'CONTACT', 'email': 'brasil@bitrialsupport.com', 'phone': '08008919295'}], 'facility': 'A.C. 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signed "Document Sharing Agreement".\n\nFurthermore, 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.', 'accessCriteria': 'For study documents - upon signing of a "Document Sharing Agreement". 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