Beamion LUNG-1: A Study to Test Different Doses of Zongertinib in People With Different Types of Advanced Cancer (Solid Tumours With Changes in the HER2 Gene)
NCT ID: NCT04886804
Last Updated: 2025-12-22
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
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
PHASE1
554 participants
INTERVENTIONAL
2021-07-02
2028-08-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
The second part is open to people with non-small cell lung cancer with a specific mutation in the HER2 gene.
The purpose of the first study part is to find the highest dose of a medicine called zongertinib the participants can tolerate. Once this dose is found, it will be used in the second study part to test whether zongertinib can make tumours shrink.
In this study, zongertinib is given to people for the first time. Participants take zongertinib as tablets once a day or twice a day.
The participants are in the study for as long as they benefit from and can tolerate treatment.
Study doctors regularly check the participants' health and monitor the tumours. The doctors also take note of any unwanted effects that could have been caused by zongertinib.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Phase Ia - Dose escalation part
Consecutive cohorts of patients treated with escalating doses of BI 1810631 monotherapy.
zongertinib
zongertinib
Phase Ib - Dose expansion part: Cohort 1
zongertinib
zongertinib
Phase Ib - Dose expansion part: Cohort 2
zongertinib
zongertinib
Phase Ib - Dose expansion part: Cohort 3
zongertinib
zongertinib
Phase Ib - Dose expansion part: Cohort 4
zongertinib
zongertinib
Phase Ib - Dose expansion part: Cohort 5
zongertinib
zongertinib
Phase Ib - Dose expansion part: Cohort 6
Cohort only in the United States of America (USA)
zongertinib
zongertinib
Phase Ib - Dose expansion part: Cohort 7
Cohort only in Japan
zongertinib
zongertinib
Phase Ib - Dose expansion part: Cohort 8
Cohort only in the United States of America (USA)
zongertinib
zongertinib
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
zongertinib
zongertinib
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Eastern Cooperative Oncology Group (ECOG) score of 0, 1 or 2 (ECOG=2 only for Cohorts 6 and 7) .
* Availability and patient willingness to provide a sample of tumour for confirmation of the patient´s Human epidermal growth factor receptor 2 (HER2) status. This sample can be archival material obtained at any time prior to study enrollment.
* Patient willing and able to comply with the protocol requirements for tumour biopsies (biopsies from brain metastases are not allowed).
* Adequate organ function defined as all of the following:
* Absolute neutrophil count (ANC) ≥ 1.5 x 10\^9/L (≥ 1.5 x 10\^3/μL) (≥ 1500/mm\^3); haemoglobin ≥ 9.0 g/dL (≥ 90 g/L) (≥ 5.6 mmol/L); platelets ≥ 100 x 10\^9/L (100 x 10\^3/μL) (100 x 10\^3/mm3) without the use of hematopoietic growth factors within 4 weeks of start of trial medication.
* Total bilirubin ≤ 1.5 times the upper limit of normal (ULN), except for patients with Gilbert's syndrome: total bilirubin ≤ 3 x ULN or direct bilirubin ≤ 1.5 x ULN.
* Estimated Glomerular Filtration Rate (eGFR) ≥ 50 mL/min - calculated using Chronic Kidney Disease Epidemiology (CKD-EPI) formula.
* Aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 3 x ULN if no demonstrable liver metastases, or otherwise ≤ 5 x ULN if transaminase elevation is attributable to liver metastases.
* Alkaline Phosphatase \< 5 x ULN.
* Recovered from any previous therapy-related toxicity to ≤ Common Terminology Criteria for Adverse Events (CTCAE) Grade 1 at start of treatment (except for alopecia, stable sensory neuropathy and hypothyroidism (patients on thyroid replacement therapy) which must be ≤ CTCAE Grade 2)
* Life expectancy of at least 12 weeks at the start of treatment in the opinion of the investigator.
* At least 18 years of age at the time of consent or over the legal age of consent in countries where that is greater than 18 years.
* Signed and dated written informed consent in accordance with International Council on Harmonisation-Good Clinical Practice (ICH-GCP) and local legislation prior to admission to the trial.
* Male or female patients. Women of childbearing potential (WOCBP) and men who are able to father a child must be ready and able to use highly effective methods of birth control per International Council on Harmonisation (ICH) M3 (R2) that result in a low failure rate of less than 1% per year when used consistently and correctly.
* Patients with a documented diagnosis of HER2 aberration: overexpression OR gene amplification OR non-synonymous somatic mutation OR gene rearrangement involving HER2 or Neuregulin 1 (NRG1)
* Patient who has failed conventional treatment or for whom no therapy of proven efficacy exists or who is not eligible for established treatment options. Patient must have exhausted, or not be a suitable candidate for, available treatment options known to prolong survival for their disease
* Non-squamous non-small cell lung cancer (NSCLC) patients with documented human epidermal growth factor receptor 2 (HER2) mutation in the tyrosine kinase domain (TKD) as per local lab results.
* Patient who had received, in the advanced/metastatic setting, at least one line of systemic therapy. Patients with non-squamous NSCLC harboring additionally genomic aberrations for which approved targeted therapy is available as standard of care.
* Non-squamous NSCLC patient with a documented HER2 mutation in the tyrosine kinase domain (TKD) as per local lab results.
* Treatment naïve for non-squamous NSCLC.
* NSCLC Patient with a documented HER2 mutation outside of the tyrosine kinase domain (TKD) as per local lab results or squamous NSCLC patient with mutation in the TKD as per local lab results.
* Patient who had received, in the advanced/metastatic setting, at least one line of systemic therapy. Patients with NSCLC harboring additionally genomic aberrations for which approved targeted therapy is available as standard of care.
* NSCLC patients with documented HER2 mutation in the TKD as per local lab results.
* NSCLC patients who are either treatment naïve or who had received any prior line of treatment, in the advanced/metastatic setting. Patients with NSCLC harboring additional genomic aberrations for which approved targeted therapy is available as standard of care.
* Patient with active brain metastases who are not eligible for immediate local therapy, as per investigator evaluation.
* Non-squamous NSCLC patients with documented HER2 mutation in the TKD as per local lab results.
* Patient should have received, in the advanced/metastatic setting, at least one line of systemic therapy that includes a platinum-based combination chemotherapy and should have been treated with previous HER2 directed antibody-drug conjugates (ADC) in the same advanced/metastatic setting and developed disease progression recurrence during or after completing this therapy. Patients with NSCLC harboring additional genomic aberrations for which approved targeted therapy is available as standard of care.
* Non-squamous NSCLC Patient with documented HER2 mutation in the TKD as per local lab results.
* Patient who had received, in the advanced/metastatic setting, at least one line of systemic therapy.
* Patient without active brain metastases or patient with active brain metastases who are not eligible for immediate local therapy, as per investigator evaluation.
* Patient who is not eligible for any other recruiting cohort.
* Non-squamous NSCLC patient with documented HER2 mutation in the TKD as per local lab results.
* Patient who had received, in the advanced/metastatic setting, at least one line of systemic therapy.
* Patient without active brain metastases or patient with active brain metastases who are not eligible for immediate local therapy, as per investigator evaluation.
* Patient who is not eligible for any other recruiting cohort.
* Treatment naïve for NSCLC
* NSCLC (adenocarcinoma or squamous) patient with documented HER2 mutation in the tyrosine kinase domain (TKD) or non-squamous NSCLC with a documented HER2 mutation in the non tyrosine kinase domain (non TKD) as per local lab results
Exclusion Criteria
* Previous or concomitant malignancies other than the one treated in this trial within the last 2 years, except:
* 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.
* Treatment with a systemic anti-cancer therapy or investigational drug within 21 days or 5 half-lives (whichever is shorter) of the first treatment with the study medication
* Patients who must or wish to continue the intake of restricted medication or any drug considered likely to interfere with the safe conduct of the trial
* Previous treatment with zongertinib.
* Radiotherapy within 2 weeks prior to first study treatment, except palliative radiotherapy to regions other than the chest, which is allowed up to 1 week prior to first study treatment.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Boehringer Ingelheim
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University of Alabama at Birmingham
Birmingham, Alabama, United States
Precision NextGen Oncology
Beverly Hills, California, United States
City of Hope-Duarte-56419
Duarte, California, United States
City of Hope - Seacliff
Huntington Beach, California, United States
City of Hope-Irvine-69674
Irvine, California, United States
Valkyrie Clinical Trials
Los Angeles, California, United States
University of California Irvine
Orange, California, United States
University of California Davis
Sacramento, California, United States
Georgetown University
Washington D.C., District of Columbia, United States
Holy Cross Hospital-Fort Lauderdale-57892
Fort Lauderdale, Florida, United States
Winship Cancer Institute
Atlanta, Georgia, United States
Hawaii Cancer Care - Honolulu
Honolulu, Hawaii, United States
Laura & Isaac Perlmutter Cancer Center at NYU Langone Health
New York, New York, United States
Duke University Medical Center
Durham, North Carolina, United States
Cleveland Clinic
Cleveland, Ohio, United States
Sarah Cannon Research Institute-Nashville-48456
Nashville, Tennessee, United States
Mary Crowley Cancer Research Center
Dallas, Texas, United States
The University of Texas MD Anderson Cancer Center
Houston, Texas, United States
Virginia Cancer Specialists, PC
Fairfax, Virginia, United States
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States
Macquarie University
Macquarie Park, New South Wales, Australia
Ordensklinikum Linz GmbH
Linz, , Austria
Brussels - HOSP Jules Bordet
Anderlecht/Brussels-Capital, , Belgium
Beijing Cancer Hospital
Beijing, , China
Jilin Province Cancer Hospital
Changchun, , China
The First Hospital of Jilin University
Changchun, , China
Fujian Cancer Hospital
Fuzhou, , China
Guangdong Provincial People's Hospital
Guangzhou, , China
The First Affiliated Hospital, Zhejiang University
Hangzhou, , China
Zhejiang Cancer Hospital
Hangzhou, , China
Harbin Medical University Cancer Hospital
Harbin, , China
The Affiliated Cancer Hospital, Guangxi Medical University
Nanning, , China
Shanghai Chest Hospital
Shanghai, , China
Wuhan Union Hospital
Wuhan, , China
Tongji Hospital Affiliated Tongji Medical College Huazhong University of S & T
Wuhan, , China
First Affiliated Hospital of Xiamen University
Xiamen, , China
Henan Cancer Hospital
Zhengzhou, , China
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, , China
HOP Louis Pradel
Bron, , France
CTR Leon Berard
Lyon, , France
HOP Timone
Marseille, , France
INS Curie
Paris, , France
HOP Pontchaillou
Rennes, , France
INS Gustave Roussy
Villejuif, , France
Universitätsklinikum Augsburg
Augsburg, , Germany
Universitätsklinikum Köln (AöR)
Cologne, , Germany
Technische Universität Dresden
Dresden, , Germany
Justus-Liebig Universität Gießen
Giessen, , Germany
Pius-Hospital, Oldenburg
Oldenburg, , Germany
Prince of Wales Hospital-Hong Kong-20715
Hong Kong, , Hong Kong
Queen Mary Hospital
Hong Kong, , Hong Kong
Rambam Medical Center
Haifa, , Israel
Meir Medical Center
Kfar Saba, , Israel
Sourasky Medical Center
Tel Aviv, , Israel
The Chaim Sheba Medical Center Tel HaShomer
Tel Litwinsky, , Israel
Istituto Di Candiolo
Candiolo (TO), , Italy
Istituto Nazionale IRCCS Tumori Fondazione Pascale
Napoli, , Italy
Azienda Ospedaliera Unversitaria di Parma
Parma, , Italy
National Cancer Center Hospital East
Chiba, Kashiwa, , Japan
Shikoku Cancer Center
Ehime, Matsuyama, , Japan
Hiroshima University Hospital
Hiroshima, Hiroshima, , Japan
Osaka International Cancer Institute
Osaka, Osaka, , Japan
Kindai University Hospital
Osaka, Sakai, , Japan
Hamamatsu University Hospital
Shizuoka, Hamamatsu, , Japan
National Cancer Center Hospital
Tokyo, Chuo-ku, , Japan
Nederlands Kanker Instituut
Amsterdam, , Netherlands
Leids Universitair Medisch Centrum (LUMC)
Leiden, , Netherlands
Hospital CUF Porto
Porto, , Portugal
National University Hospital-Singapore-22806
Singapore, , Singapore
National Cancer Centre Singapore
Singapore, , Singapore
Chungbuk National University Hospital
Chungju, , South Korea
Seoul National University Bundang Hospital
Seongnam, , South Korea
Severance Hospital
Seoul, , South Korea
Asan Medical Center
Seoul, , South Korea
Samsung Medical Center
Seoul, , South Korea
Hospital Universitari Vall D Hebron
Barcelona, , Spain
Hospital Duran i Reynals
L'Hospitalet de Llobregat, , Spain
Hospital General Universitario Gregorio Marañón
Madrid, , Spain
Hospital Universitario 12 de Octubre
Madrid, , Spain
Hospital Virgen de la Victoria
Málaga, , Spain
Hospital Clinico Universitario De Valencia
Valencia, , Spain
Karolinska Universitetssjukhuset Solna
Stockholm, , Sweden
The Royal Marsden Hospital, Chelsea
London, , United Kingdom
Hammersmith Hospital
London, , United Kingdom
The Royal Marsden Hospital, Sutton
Sutton, , United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Additional US locations available on demand. Please contact for options.
Role: CONTACT
Phone: 1-800-243-0127
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Boehringer Ingelheim
Role: primary
Boehringer Ingelheim
Role: primary
Boehringer Ingelheim
Role: primary
Boehringer Ingelheim
Role: primary
Boehringer Ingelheim
Role: primary
Boehringer Ingelheim
Role: primary
Boehringer Ingelheim
Role: primary
Boehringer Ingelheim
Role: primary
Boehringer Ingelheim
Role: primary
Boehringer Ingelheim
Role: primary
Boehringer Ingelheim
Role: primary
Boehringer Ingelheim
Role: primary
Boehringer Ingelheim
Role: primary
Boehringer Ingelheim
Role: primary
Boehringer Ingelheim
Role: primary
Boehringer Ingelheim
Role: primary
Boehringer Ingelheim
Role: primary
Boehringer Ingelheim
Role: primary
Boehringer Ingelheim
Role: primary
Boehringer Ingelheim
Role: primary
Boehringer Ingelheim
Role: primary
Boehringer Ingelheim
Role: primary
Boehringer Ingelheim
Role: primary
Boehringer Ingelheim
Role: primary
Boehringer Ingelheim
Role: primary
Boehringer Ingelheim
Role: primary
Boehringer Ingelheim
Role: primary
Boehringer Ingelheim
Role: primary
References
Explore related publications, articles, or registry entries linked to this study.
Heymach JV, Ruiter G, Ahn MJ, Girard N, Smit EF, Planchard D, Wu YL, Cho BC, Yamamoto N, Sabari JK, Zhao Y, Tu HY, Yoh K, Nadal E, Sadrolhefazi B, Rohrbacher M, von Wangenheim U, Eigenbrod-Giese S, Zugazagoitia J; Beamion LUNG-1 Investigators. Zongertinib in Previously Treated HER2-Mutant Non-Small-Cell Lung Cancer. N Engl J Med. 2025 Jun 19;392(23):2321-2333. doi: 10.1056/NEJMoa2503704. Epub 2025 Apr 28.
Heymach JV, Opdam F, Barve M, Tu HY, Wu YL, Berz D, Schroter L, Botilde Y, Sadrolhefazi B, Serra J, Yoh K, Yamamoto N. HER2-Selective Tyrosine Kinase Inhibitor, Zongertinib (BI 1810631), in Patients With Advanced/Metastatic Solid Tumors With HER2 Alterations: A Phase Ia Dose-Escalation Study. J Clin Oncol. 2025 Apr 10;43(11):1337-1347. doi: 10.1200/JCO-24-01727. Epub 2025 Mar 3.
Heymach J, Opdam F, Barve M, Gibson N, Sadrolhefazi B, Serra J, Yamamoto N. A Phase I, Open-Label, Dose Confirmation, Escalation, and Expansion Trial of BI 1810631 as Monotherapy in Patients With Advanced or Metastatic Solid Tumors With HER2 Aberrations. Clin Lung Cancer. 2023 Mar;24(2):e65-e68. doi: 10.1016/j.cllc.2022.10.008. Epub 2022 Nov 11.
Related Links
Access external resources that provide additional context or updates about the study.
Related Info
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2020-004563-47
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
2024-511246-39-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
U1111-1312-5969
Identifier Type: REGISTRY
Identifier Source: secondary_id
1479-0001
Identifier Type: -
Identifier Source: org_study_id