Beamion LUNG-2: A Study to Test Whether Zongertinib (BI 1810631) Helps People With Advanced Non-small Cell Lung Cancer With HER2 Mutations Compared With Standard Treatment
NCT ID: NCT06151574
Last Updated: 2025-11-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
416 participants
INTERVENTIONAL
2024-02-09
2028-01-28
Brief Summary
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Participants are put into 2 groups by chance. One group receives zongertinib at regular times throughout the study and the other group receives infusions of pembrolizumab, pemetrexed and cisplatin or carboplatin (pembrolizumab plus platinum-pemetrexed chemotherapy) into a vein.
Participants may be in the study up to a maximum of 70 months. During this time, they visit the study site about every 3 weeks for study procedures. The doctors regularly check the size of the tumour with a CT or MRI scan, at the beginning of the study and every 6 weeks. After 18 months they check the tumour size every 12 weeks. Doctors regularly check whether the cancer has spread to other parts of the body. The doctors also regularly check participants' health and take note of any unwanted effects. The time it takes for the cancer to worsen is compared between the 2 groups to see whether the treatment works. The participants also fill in questionnaires about their symptoms and quality of life.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Experimental treatment arm
zongertinib only
zongertinib
zongertinib
Comparator arm
pembrolizumab plus platinum-pemetrexed chemotherapy
pembrolizumab
pembrolizumab
cisplatin
platinum-pemetrexed chemotherapy
carboplatin
platinum-pemetrexed chemotherapy
pemetrexed
platinum-pemetrexed chemotherapy
Interventions
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zongertinib
zongertinib
pembrolizumab
pembrolizumab
cisplatin
platinum-pemetrexed chemotherapy
carboplatin
platinum-pemetrexed chemotherapy
pemetrexed
platinum-pemetrexed chemotherapy
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Patients ≥18 years of age or over the legal age of consent in countries where that is greater than 18 years at the time of signature of the ICF.
3. Histologically or cytologically confirmed diagnosis of an advanced and/or metastatic non-squamous Non-small cell lung cancer (NSCLC).
4. Documented Human epidermal growth factor receptor 2 (HER2) mutation in the Tyrosine kinase domain (TKD) as per local lab results.
5. An archival tumor tissue sample must be submitted to the central laboratory after inclusion of the patient to retrospectively confirm the HER2 status. If no archival tissue is available, this may be acceptable in exceptional cases after written agreement with the sponsor.
6. Patients who have not received any systemic treatment for unresectable, locally advanced or metastatic disease and are not eligible for curative therapy.
7. Presence of at least one measurable lesion according to Response evaluation criteria in solid tumors (RECIST) 1.1, as determined by the local site investigator/radiology assessment.
8. Eligible to receive treatment with the selected platinum-based doublet-chemotherapy (i.e. cisplatin/pemetrexed or carboplatin/pemetrexed) and pembrolizumab in accordance with the Summaries of Product Characteristics (SmPC)/Product Information.
Exclusion Criteria
* effectively treated non-melanoma skin cancers
* effectively treated carcinoma in situ of the cervix
* effectively treated ductal carcinoma in situ
* other effectively treated malignancy that is considered cured by local treatment
2. Tumors with targetable alterations with approved available therapy.
3. Lung-specific intercurrent clinically significant severe illness based on investigators assessment.
4. Patients who must or wish to continue the intake of restricted medications or any drug considered likely to interfere with the safe conduct of the trial.
5. Major surgery (major according to the investigator's assessment) performed within 4 weeks prior to randomization or planned within 6 months after screening, e.g. hip replacement.
6. Any history of or concomitant condition that, in the opinion of the investigator, would compromise the patient's ability to comply with the trial or interfere with the evaluation of the safety and efficacy of the test drug.
7. History or presence of cardiovascular abnormalities such as uncontrolled hypertension, congestive heart failure New York Heart Association (NYHA) classification of ≥ III or IV, unstable angina or poorly controlled arrhythmia which are considered as clinically relevant by the investigator. Myocardial infarction, stroke, or pulmonary embolism within 6 months prior to randomization.
8. Any clinically important abnormalities (as assessed by the investigator) in rhythm, conduction, or morphology of resting electrocardiograms, e.g. complete left bundle branch block, third degree heart block.
18 Years
ALL
No
Sponsors
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Boehringer Ingelheim
INDUSTRY
Responsible Party
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Locations
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Clearview Cancer Institute
Huntsville, Alabama, United States
Pioneer Research Center - Bullhead City
Bullhead City, Arizona, United States
Precision NextGen Oncology
Beverly Hills, California, United States
ClinRé 001-022 (Premier Cancer Care and Infusion Center)
Fresno, California, United States
OPN Healthcare, Inc.
Glendale, California, United States
Scripps Green Hospital
La Jolla, California, United States
Valkyrie Clinical Trials
Los Angeles, California, United States
Sharp Memorial Hospital
San Diego, California, United States
St. Louis Cancer Care, LLP
Bridgeton, Missouri, United States
Oncology Hematology Associates
Springfield, Missouri, United States
Cancer Care Specialists
Reno, Nevada, United States
Northwell Health
Lake Success, New York, United States
Montefiore Medical Center
The Bronx, New York, United States
Regional Medical Oncology Center
Wilson, North Carolina, United States
Gabrail Cancer Center
Canton, Ohio, United States
Carolina Blood and Cancer Care Associates, PA
Rock Hill, South Carolina, United States
SCRI Oncology Partners
Nashville, Tennessee, United States
Huntsman Cancer Institute
Salt Lake City, Utah, United States
Virginia Cancer Specialists, PC
Fairfax, Virginia, United States
Swedish Cancer Institute
Edmonds, Washington, United States
Swedish Cancer Institute
Issaquah, Washington, United States
Swedish Cancer Institute
Seattle, Washington, United States
Clinica Adventista Belgrano
CABA, , Argentina
Instituto Medico Especializado Alexander Fleming
Ciudad Autónoma de Bs As, , Argentina
Instituto Oncologico de Cordoba
Córdoba, , Argentina
Centro Oncologico Riojano Integral (CORI)
La Rioja, , Argentina
Instituto Médico de la Fundación Estudios Clínicos
Rosario, , Argentina
Clinicas Viedma S.A.
Viedma, , Argentina
Prince of Wales Hospital-Randwick-66496
Randwick, New South Wales, Australia
Royal North Shore Hospital-St Leonards-20807
St Leonards, New South Wales, Australia
Princess Alexandra Hospital
Woolloongabba, Queensland, Australia
Austin Health
Heidelberg, Victoria, Australia
St John of God Subiaco Hospital
Subiaco, Western Australia, Australia
Krems University Hospital
Krems, , Austria
Clinic Floridsdorf
Vienna, , Austria
Brussels - HOSP Jules Bordet
Anderlecht, , Belgium
Universitair Ziekenhuis Gent
Ghent, , Belgium
UZ Leuven
Leuven, , Belgium
Associacao Dr. Bartholomeu Tacchini
Bento Gonçalves, , Brazil
Hospital do Cancer de Londrina
Londrina, , Brazil
Hospital Sao Lucas da PUCRS
Porto Alegre, , Brazil
OncoClinicas Rio de Janeiro
Rio de Janeiro, , Brazil
CEPHO - Centro de Estudos e Pesquisas em Hematologia e Oncologia
Santo André, , Brazil
Fundação Faculdade Regional de Medicina de São José do Rio Preto
São José do Rio Preto, , Brazil
ICESP - Instituto do Cancer do Estado de Sao Paulo
São Paulo, , Brazil
Princess Margaret Cancer Centre
Toronto, Ontario, Canada
Bradford Hill- Centro de Investigación Clínica
Recoleta, , Chile
Cancer Hospital of Chinese Academy of Medical Science
Beijing, , China
Beijing Cancer Hospital
Beijing, , China
West China Hospital of Sichuan University
Chengdu, , China
Fujian Cancer Hospital
Fuzhou, , China
Guangdong Provincial People's Hospital
Guangzhou, , China
The First Affiliated Hospital, Zhejiang University
Hangzhou, , China
Sir Run Run Shaw Hospital, Zhejiang University, School of Medicine
Hangzhou, , China
Zhejiang Cancer Hospital
Hangzhou, , China
Harbin Medical University Cancer Hospital
Harbin, , China
Fudan University Shanghai Cancer Center
Shanghai, , China
Zhongshan Hospital Affiliated to Fudan University
Shanghai, , China
Taizhou Hospital of Zhejiang Province
Taizhou, , China
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, , China
Wuhan Union Hospital
Wuhan, , China
First Affiliated Hospital of Xiamen University
Xiamen, , China
Henan Cancer Hospital
Zhengzhou, , China
HOP Louis Pradel
Bron, , France
CTR Leon Berard
Lyon, , France
HOP Nord
Marseille, , France
HOP Tenon
Paris, , France
INS Curie
Paris, , France
HOP Pontchaillou
Rennes, , France
HOP Civil
Strasbourg, , France
HOP Larrey
Toulouse, , France
INS Gustave Roussy
Villejuif, , France
Universitätsklinikum Augsburg
Augsburg, , Germany
Gemeinschaftskrankenhaus Havelhöhe gGmbH
Berlin, , Germany
Universitätsklinikum Köln (AöR)
Cologne, , Germany
Universitätsklinikum Carl Gustav Carus Dresden
Dresden, , Germany
Justus-Liebig Universität Gießen
Giessen, , Germany
Thoraxklinik-Heidelberg gGmbH am Universitätsklinikum Heidelberg
Heidelberg, , Germany
Pius-Hospital, Oldenburg
Oldenburg, , Germany
Universitätsklinikum Tübingen
Tübingen, , Germany
Queen Elizabeth Hospital-Hong Kong-51727
Hong Kong, , Hong Kong
Princess Margaret Hospital
Hong Kong, , Hong Kong
Queen Mary Hospital
Hong Kong, , Hong Kong
Koranyi National Institute For Pulmonolgy
Budapest, , Hungary
National Institute of Oncology
Budapest, , Hungary
Deszk Hospital of Chest Diseases
Deszk, , Hungary
Pulmonology Institute of Veszprem County, Farkasgyepu
Farkasgyepű, , Hungary
Fejer County Saint George University Teaching Hospital
Székesfehérvár, , Hungary
Rambam Medical Center
Haifa, , Israel
Meir Medical Center
Kfar Saba, , Israel
Rabin Medical Center Beilinson
Petah Tikva, , Israel
Sourasky Medical Center
Tel Aviv, , Israel
Istituto Tumori Giovanni Paolo II
Bari, , Italy
Istituto Di Candiolo
Candiolo (TO), , Italy
AOU Policlinico G. Rodolico San Marco
Catania, , Italy
Istituto Nazionale IRCCS Tumori Fondazione Pascale
Napoli, , Italy
Azienda Ospedaliera Unversitaria di Parma
Parma, , Italy
AOU Policlinico Umberto I
Roma, , Italy
A. O. Ospedale Circolo Fond. Macchi
Varese, , Italy
Aichi Cancer Center Hospital
Aichi, Nagoya, , Japan
Hirosaki University Hospital
Aomori, Hirosaki, , Japan
National Cancer Center Hospital East
Chiba, Kashiwa, , Japan
Shikoku Cancer Center
Ehime, Matsuyama, , Japan
Kyushu University Hospital
Fukuoka, Fukuoka, , Japan
Hakodate Goryoukaku Hospital
Hokkaido, Hakodate, , Japan
Hokkaido Cancer Center
Hokkaido, Sapporo, , Japan
Kanazawa University Hospital
Ishikawa, Kanazawa, , Japan
St. Marianna University Hospital
Kanagawa, Kawasaki, , Japan
Kanagawa Cancer Center
Kanagawa, Yokohama, , Japan
University Hospital Kyoto Prefectural University of Medicine
Kyoto, Kyoto, , Japan
Tohoku University Hospital
Miyagi, Sendai, , Japan
Okayama University Hospital
Okayama, Okayama, , Japan
Osaka International Cancer Institute
Osaka, Osaka, , Japan
Shizuoka Cancer Center
Shizuoka, Sunto-gun, , Japan
Juntendo University Hospital
Tokyo, Bunkyo-ku, , Japan
Komagome Hospital
Tokyo, Bunkyo-ku, , Japan
National Cancer Center Hospital
Tokyo, Chuo-ku, , Japan
Japanese Foundation for Cancer Research
Tokyo, Koto-ku, , Japan
Wakayama Medical University Hospital
Wakayama, Wakayama, , Japan
Health Pharma Professional Research S.A. de C.V.
Mexico City, , Mexico
Instituto Nacional de Cancerologia
México, , Mexico
FAICIC S de RL de C.V.
Veracruz, , Mexico
Nederlands Kanker Instituut - Antoni van Leeuwenhoek Amsterdam (METC AVL)
Amsterdam, , Netherlands
Maastricht University
Maastricht, , Netherlands
Vestre Viken HF, Drammen Sykehus
Drammen, , Norway
Oslo Universitetssykehus HF, Radiumhospitalet
Oslo, , Norway
Polish Mother's Memorial Hospital - Research Institute
Lodz, , Poland
Greater Poland Center of Pulmonology and Thoracic Surgery
Poznan, , Poland
MED POLONIA SP Z O O, Clinical Trials Department,Poznan
Poznan, , Poland
Oncology Center-Maria Sklodowska-Curie Institute
Warsaw, , Poland
Hospital CUF Tejo
Lisbon, , Portugal
Centro Hospitalar Lisboa Norte Hospital Pulido Valente
Lisbon, , Portugal
Hospital CUF Porto
Porto, , Portugal
Pan American Center for Oncology Trials, LLC
Rio Piedras, , Puerto Rico
National University Hospital-Singapore-22806
Singapore, , Singapore
National Cancer Centre Singapore
Singapore, , Singapore
Chungbuk National University Hospital
Cheongiu, , South Korea
National Cancer Center
Goyang, , South Korea
Gachon University Gil Medical Center
Incheon, , South Korea
Kangbuk Samsung Hospital
Seoul, , South Korea
Severance Hospital
Seoul, , South Korea
Asan Medical Center
Seoul, , South Korea
Samsung Medical Center
Seoul, , South Korea
The Catholic University of Korea, St.Vincent's Hospital
Suwon, , South Korea
Complejo Hospitalario Universitario A Coruña
A Coruña, , Spain
Hospital General Universitario de Alicante
Alicante, , Spain
Hospital Santa Creu i Sant Pau
Barcelona, , Spain
Hospital Universitari Vall D Hebron
Barcelona, , Spain
Hospital de Basurto
Bilbao, , Spain
Hospital Duran i Reynals
L'Hospitalet de Llobregat, , Spain
Hospital General Universitario Gregorio Marañón
Madrid, , Spain
Hospital Universitario Ramon Y Cajal
Madrid, , Spain
Hospital Universitario 12 de Octubre
Madrid, , Spain
Hospital Universitario La Paz
Madrid, , Spain
Hospital Regional Universitario de Málaga
Málaga, , Spain
Hospital Virgen del Rocío
Seville, , Spain
Hospital Clinico Universitario De Valencia
Valencia, , Spain
Sahlgrenska Universitetsjukhuset
Gothenburg, , Sweden
Karolinska Universitetssjukhuset Solna
Stockholm, , Sweden
Kaohsiung Chang Gung Memorial Hospital
Kaohsiung City, , Taiwan
Chung Shan Medical University Hospital
Taichung, , Taiwan
National Taiwan University Hospital
Taipei, , Taiwan
National Taiwan University Cancer Center
Taipei, , Taiwan
Chang Gung Memorial Hospital, Linkou
Taoyuan District, , Taiwan
Western General Hospital
Edinburgh, , United Kingdom
Leicester Royal Infirmary
Leicester, , United Kingdom
Guy's Hospital
London, , United Kingdom
The Royal Marsden Hospital, Chelsea
London, , United Kingdom
The Royal Marsden Hospital, Sutton
Sutton, , United Kingdom
Countries
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Central Contacts
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Facility Contacts
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Related Links
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Related Info
Other Identifiers
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2023-504308-27-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
U1111-1294-1407
Identifier Type: OTHER
Identifier Source: secondary_id
1479-0008
Identifier Type: -
Identifier Source: org_study_id