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
NCT ID: NCT07195695
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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NOT_YET_RECRUITING
PHASE3
400 participants
INTERVENTIONAL
2025-12-05
2036-09-02
Brief Summary
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In 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).
Participants 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.
Doctors 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.
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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Zongertinib treatment arm
Zongertinib
Zongertinib
Standard of Care (SoC) treatment arm
Pembrolizumab
Pembrolizumab
Atezolizumab
Atezolizumab
Durvalumab
Durvalumab
Nivolumab
Nivolumab
Interventions
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Zongertinib
Zongertinib
Pembrolizumab
Pembrolizumab
Atezolizumab
Atezolizumab
Durvalumab
Durvalumab
Nivolumab
Nivolumab
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
Exclusion Criteria
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
18 Years
ALL
No
Sponsors
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Boehringer Ingelheim
INDUSTRY
Responsible Party
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Locations
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Premier Cancer Care
Fresno, California, United States
OPN Healthcare, Inc.
Glendale, California, United States
Sutter Health
Roseville, California, United States
University of California Los Angeles
Santa Monica, California, United States
Northern California Kaiser Permanente
Vallejo, California, United States
George Washington University Cancer Center
Washington D.C., District of Columbia, United States
Mid Florida Hematology and Oncology Center
Orange City, Florida, United States
Piedmont Cancer Institute
Atlanta, Georgia, United States
Northwest Georgia Oncology Centers
Marietta, Georgia, United States
Saint Alphonsus Regional Medical Center - Boise
Boise, Idaho, United States
Northwestern University
Chicago, Illinois, United States
University of Illinois Hospital and Health Sciences System
Chicago, Illinois, United States
Duly Health and Care - Lisle
Lisle, Illinois, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
Cancer Care Specialists
Reno, Nevada, United States
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States
Laura & Isaac Perlmutter Cancer Center at NYU Langone Health
New York, New York, United States
Memorial Sloan-Kettering Cancer Center
New York, New York, United States
Providence Cancer Institute
Portland, Oregon, United States
Hendrick Health
Abilene, Texas, United States
Community Cancer Trials of Utah
Ogden, Utah, United States
Virginia Cancer Specialists, PC
Fairfax, Virginia, United States
Centro de Investigaciones Médicas y Desarrollo LC S.R.L. (LC Investigación)
CABA, , Argentina
Hospital Britanico de Buenos Aires
CABA, , Argentina
Centro Oncologico Korben
CABA, , Argentina
Clinica Adventista Belgrano
CABA, , Argentina
Instituto Medico Especializado Alexander Fleming
Capital Federal, , Argentina
Clinic Floridsdorf
Vienna, , Austria
Edegem - UNIV UZ Antwerpen
Edegem, , Belgium
UZ Leuven
Leuven, , Belgium
Centre Hospitalier Universitaire de Liège
Liège, , Belgium
Hospital de Amor
Barretos, , Brazil
NewData Clinical Research - Maceió
Maceió, , Brazil
Centro de Pesquisa Oncology Natal
Natal, , Brazil
Centro Gaúcho Integrado de Oncologia, Hematologia, Ensino e Pesquisa
Porto Alegre, , Brazil
CEPHO - Centro de Estudos e Pesquisas em Hematologia e Oncologia
Santo André, , Brazil
ICESP - Instituto do Cancer do Estado de Sao Paulo
São Paulo, , Brazil
A.C. Camargo
São Paulo, , Brazil
Princess Margaret Cancer Centre
Toronto, Ontario, Canada
Centro de Estudios Clinicos SAGA
Providencia, , Chile
Bradford Hill- Centro de Investigación Clínica
Recoleta, , Chile
China-Japan Friendship Hospital
Beijing, , China
The First Hospital of Jilin University
Changchun, , China
Sichuan Cancer Hospital
Chengdu, , China
West China Hospital of Sichuan University
Chengdu, , China
The First Affiliated Hospital, Zhejiang University
Hangzhou, , China
Harbin Medical University Cancer Hospital
Harbin, , China
Shandong Cancer Hospital
Jinan, , China
Yunnan Provincial Tumor Hospital
Kunming, , China
Linyi Cancer Hospital
Linyi, , China
The First Affiliated Hospital of Nanchang University
Nanchang, , China
Shanghai East Hospital
Shanghai, , China
Shanghai Pulmonary Hospital
Shanghai, , China
Hebei Provincial Tumor Hospital
Shijiazhuang, , China
The First Affiliated Hospital of Soochow University
Suzhou, , China
Taizhou Hospital of Zhejiang Province
Taizhou, , China
Tianjin Cancer Hospital
Tianjin, , China
Tianjin Medical University General Hospital
Tianjin, , China
Wuhan Union Hospital
Wuhan, , China
Affiliated Hospital, Xuzhou Medical college
Xuzhou, , China
Northern Jiangsu People's Hospital
Yangzhou, , China
Sjællands Universitetshospital
Roskilde, , Denmark
National Cancer Institute, Cairo University
Cairo, , Egypt
Shefaa El Orman Oncology Hospital
Luxor, , Egypt
HOP Louis Pradel
Bron, , France
HOP Nord Laennec
Nantes, , France
HOP Pontchaillou
Rennes, , France
Centre Régional de Lutte Contre le Cancer Paul Stauss
Strasbourg, , France
HOP Larrey
Toulouse, , France
INS Gustave Roussy
Villejuif, , France
Universitätsklinikum Köln (AöR)
Cologne, , Germany
Klinikum Esslingen
Esslingen am Neckar, , Germany
Varisano LungenZentrum (VLZ)
Frankfurt, , Germany
Asklepios Fachkliniken München-Gauting
Gauting, , Germany
LungenClinic Grosshansdorf GmbH
Großhansdorf, , Germany
Thoraxklinik-Heidelberg gGmbH am Universitätsklinikum Heidelberg
Heidelberg, , Germany
Pius-Hospital, Oldenburg
Oldenburg, , Germany
Universitätsklinikum Würzburg AÖR
Würzburg, , Germany
Henry Dunant Hospital, Athens
Athens, , Greece
Chest Hospital of Athens "Sotiria"
Athens, , Greece
University General Hospital Attikon
Athens, , Greece
Queen Elizabeth Hospital-Hong Kong-51727
Hong Kong, , Hong Kong
Prince of Wales Hospital-Hong Kong-20715
Hong Kong, , Hong Kong
Princess Margaret Hospital
Hong Kong, , Hong Kong
Queen Mary Hospital
Hong Kong, , Hong Kong
Rambam Health Care Campus
Haifa, , Israel
Shaare Zedek Medical Center, Jerusalem 91031
Jerusalem, , Israel
Meir Medical Center
Kfar Saba, , Israel
Sheba Medical Center
Ramat Gan, , Israel
Sourasky Medical Center
Tel Aviv, , Israel
Istituto Tumori Giovanni Paolo II
Bari, , Italy
Fondazione IRCCS Istituto Nazionale dei Tumori
Milan, , Italy
Humanitas Istituto Clinico Catanese S.p.A.
Misterbianco (CT), , Italy
Istituto Nazionale IRCCS Tumori Fondazione Pascale
Napoli, , Italy
AOU San Luigi Gonzaga
Orbassano (TO), , Italy
Istituti Fisioterapici Ospitalieri
Roma, , Italy
Istituto Clinico Humanitas
Rozzano (MI), , Italy
Azienda Ospedaliera Universitaria Integrata Verona
Verona, , Italy
Aichi Cancer Center Hospital
Aichi, Nagoya, , Japan
Fujita Health University Hospital
Aichi, Toyoake, , Japan
National Cancer Center Hospital East
Chiba, Kashiwa, , Japan
Kyushu University Hospital
Fukuoka, Fukuoka, , Japan
Hospital of the University of Occupational and Environmental Health
Fukuoka, Kitakyushu, , Japan
Hiroshima University Hospital
Hiroshima, Hiroshima, , Japan
Hokkaido Cancer Center
Hokkaido, Sapporo, , Japan
Kitasato University Hospital
Kanagawa, Sagamihara, , Japan
Kanagawa Cancer Center
Kanagawa, Yokohama, , Japan
Sendai Kousei Hospital
Miyagi, Sendai, , Japan
Niigata Cancer Center Hospital
Niigata, Niigata, , Japan
Okayama University Hospital
Okayama, Okayama, , Japan
Kansai Medical University Hospital
Osaka, Hirakata, , Japan
Osaka International Cancer Institute
Osaka, Osaka, , Japan
Kindai University Hospital
Osaka, Sakai, , Japan
National Hospital Organization Kinki-Chuo Chest Medical Center
Osaka, Sakai, , Japan
Saitama Medical University International Medical Center
Saitama, Hidaka, , Japan
Saitama Cancer Center
Saitama, Kitaadachi-gun, , Japan
Shizuoka Cancer Center
Shizuoka, Sunto-gun, , Japan
Jichi Medical University Hospital
Tochigi, Shimotsuke, , Japan
Juntendo University Hospital
Tokyo, Bunkyo-ku, , Japan
National Cancer Center Hospital
Tokyo, Chuo-ku, , Japan
Japanese Foundation for Cancer Research
Tokyo, Koto-ku, , Japan
Tokyo Medical University Hospital
Tokyo, Shinjuku-ku, , Japan
Wakayama Medical University Hospital
Wakayama, Wakayama, , Japan
Centro Oncologico Internacional
Jalisco, , Mexico
Centro de Infusion Profesional Integral (CIPI)
Mexico City, , Mexico
Instituto Nacional de Cancerologia
México, , Mexico
Centro Medico Zambrano Hellion
Monterrey, , Mexico
Nederlands Kanker Instituut - Antoni van Leeuwenhoek Amsterdam (METC AVL)
Amsterdam, , Netherlands
Hospital CUF Tejo
Lisbon, , Portugal
Hospital da Luz
Lisbon, , Portugal
Hospital CUF Porto
Porto, , Portugal
IPO Porto Francisco Gentil, EPE
Porto, , Portugal
Lotus Med
Bucharest, , Romania
Memorial Healthcare International
Bucharest, , Romania
Ovidius Clinical Hospital S.R.L
Ovidiu, , Romania
Polaris Medical S.A.
Suceagu/ Cluj Napoca, , Romania
National Cancer Center
Goyang, , South Korea
Seoul National University Bundang Hospital
Seongnam, , South Korea
Seoul National University 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
Ajou University Hospital
Suwon, , South Korea
Hospital del Mar
Barcelona, , Spain
Hospital Vall Hebron
Barcelona, , Spain
Hospital Universitario De Burgos
Burgos, , Spain
Hospital General Universitario de Elche
Elche, , Spain
Hospital Jerez de la Frontera
Jerez de la Frontera, , Spain
Hospital Duran i Reynals
L'Hospitalet de Llobregat, , Spain
Hospital Universitario Ramon Y Cajal
Madrid, , Spain
Fundación Jiménez Díaz
Madrid, , Spain
Hospital Universitario 12 de Octubre
Madrid, , Spain
Hospital Puerta de Hierro
Madrid, , Spain
Hospital Virgen de la Victoria
Málaga, , Spain
Complejo Hospitalario de Navarra
Pamplona, , Spain
Salut Sant Joan de Reus
Reus, , Spain
Hospital Virgen del Rocío
Seville, , Spain
Hospital Clinico Universitario De Valencia
Valencia, , Spain
Sahlgrenska Universitetsjukhuset
Gothenburg, , Sweden
Karolinska Universitetssjukhuset Solna
Stockholm, , Sweden
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, , Taiwan
China Medical University Hospital
Taichung, , Taiwan
National Taiwan University Hospital
Taipei, , Taiwan
Taipei Veterans General Hospital
Taipei, , Taiwan
Tri-Service General Hospital
Taipei, , Taiwan
Chang Gung Memorial Hospital, Linkou
Taoyuan, , Taiwan
Sağlık Bilimleri Üniversitesi Gülhane Eğitim ve Araştırma Hastanesi
Ankara, , Turkey (Türkiye)
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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U1111-1320-6149
Identifier Type: REGISTRY
Identifier Source: secondary_id
2025-521284-12-00
Identifier Type: CTIS
Identifier Source: secondary_id
1479-0032
Identifier Type: -
Identifier Source: org_study_id