Beamion 44: A Study to Test How Well Zongertinib is Tolerated by People With Advanced Non-small Cell Lung Cancer With HER2 Mutations When Given in Combination With Chemotherapy With or Without Pembrolizumab
This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.
About the trial
This study is open to adults with a type of lung cancer called HER2-mutant non-squamous non-small cell lung cancer (NSCLC) that is advanced or has spread. People who have a tumor with a HER2 mutation and have not received previous treatment for their lung cancer can participate in the study. The purpose of this study is to find out how well a medicine called zongertinib is tolerated in people with this type of lung cancer, when combined with chemotherapy, with or without pembrolizumab. Zongertinib works by targeting and blocking HER2, a protein involved in cancer cell growth. Participants are put into two groups randomly, which means by chance. One group gets zongertinib tablets combined with platinum-based chemotherapy. The other group gets the same treatment plus an additional medicine called pembrolizumab. Chemotherapy and pembrolizumab are given as an infusion into a vein. Participants take zongertinib by mouth once a day, while chemotherapy is given every 3 weeks for up to 3 months, followed by maintenance treatment for up to 2 years. Pembrolizumab is given every 3 weeks for up to 2 years. This study does not have a fixed duration. Participants can receive some of the study treatments for up to about 2 years and may continue to take zongertinib as long as they benefit from treatment and can tolerate it. During this time, they visit the study site regularly. Doctors regularly check the size of the tumor and whether it has spread. They also monitor participants' health and take note of any unwanted effects.
Original English text from ClinicalTrials.gov
Who can (and can't) join
✓ Qualifies
- •Osoby w wieku 18 lat lub starsze.
- •Zaawansowany rak płuca (nie płaskonabłonkowy) z potwierdzoną mutacją HER2.
- •Pacjenci, którzy wcześniej nie byli leczeni z powodu tego raka.
- •Obecność przynajmniej jednej widocznej zmiany nowotworowej (nie w mózgu).
- •Ogólny dobry stan zdrowia (wg skali ECOG 0 lub 1).
✗ Disqualifies
- •Nowotwory z innymi usterkami genetycznymi, dla których istnieje już skuteczne leczenie.
- •Przerzuty do opon mózgowych lub historia takiej choroby.
- •Niedawne leczenie radioterapią lub przyjmowanie innych leków z grupy HER2.
- •Poważne zabiegi chirurgiczne w ciągu ostatnich 4 tygodni lub planowane w ciągu 6 miesięcy.
Simplified criteria — AI translation
Trial details
- Minimum age
- 18 Years
- Last updated (source)
- July 22, 2026
- Sex
- No restrictions
Therapies / drugs in trial
Locations (17)
Royal North Shore Hospital
St Leonards, Australia
Cabrini Health
Malvern, Australia
Fiona Stanley Hospital
Murdoch, Australia
Guangdong Provincial People's Hospital
Guangzhou, China
Shanghai Geriatric Medical Center
Shanghai, China
CTR Leon Berard
Lyon, France
INS Curie
Paris, France
Universitätsklinikum Köln (AöR)
Cologne, Germany
Thoraxklinik-Heidelberg gGmbH am Universitätsklinikum Heidelberg
Heidelberg, Germany
Kindai University Hospital
Osaka, Sakai, Japan
National Cancer Center Hospital
Tokyo, Chuo-ku, Japan
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 Universitario 12 de Octubre
Madrid, Spain
Hospital Virgen del Rocío
Seville, Spain
Trial contact
Boehringer Ingelheim
Contact information from ClinicalTrials.gov. Contact in English.
Share this trial
Data from ClinicalTrials.gov. AI-assisted translation, last sync: 7/8/2026.
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