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Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.
Additional US locations available on demand. Please contact for options.
1-800-243-0127
Boehringer Ingelheim
1-800-243-0127
clintriage.rdg@boehringer-ingelheim.com
Neoplasm Metastasis Non-Small Cell Lung Cancer
This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.
The study has 2 parts. The first part is open to adults with different types of advanced cancer (solid tumours with changes in the HER2 gene) for whom previous treatment was not successful.
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.
Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.
The recruitment start and end dates are as follows:
"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."; "40293180"; "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."; "40030100"; "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."; "36528522"
You can take part if:
You may not be able to take part if:
This is in the inclusion criteria above
Below are the locations for where you can take part in the trial. Please note that not all sites may be open.
Boehringer Ingelheim
1-800-243-0127
clintriage.rdg@boehringer-ingelheim.com
Additional US locations available on demand. Please contact for options.
1-800-243-0127
The study is sponsored by Boehringer Ingelheim
Your feedback is important to us. It will help us improve the quality of the study information on this site. Please answer both questions.
You can print or share the study information with your GP/healthcare provider or contact the research team directly.
