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Study identifier: NCT07486817 Synced from ClinicalTrials.gov · July 28, 2026
● Recruiting

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

Condition: Lung Cancer, Non-squamous, Non-small Cell  ·  Sponsor: Boehringer Ingelheim

PhasePhase 2
Planned participants60
Who can joinAll sexes, 18 Years to no upper limit
Healthy volunteersNo

About this study

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 …

This description comes directly from the study's public registry record.

Talk to the study team

Boehringer Ingelheim  ·  18002430127  ·  clintriage.rdg@boehringer-ingelheim.com

Always discuss trial participation with your own doctor first.

Locations (17)

Royal North Shore HospitalSt Leonards, New South Wales, AustraliaNot Yet Recruiting
Cabrini HealthMalvern, Victoria, AustraliaNot Yet Recruiting
Fiona Stanley HospitalMurdoch, Western Australia, AustraliaNot Yet Recruiting
Guangdong Provincial People's HospitalGuangzhou, ChinaRecruiting
Shanghai Geriatric Medical CenterShanghai, ChinaRecruiting
CTR Leon BerardLyon, FranceRecruiting
INS CurieParis, FranceNot Yet Recruiting
Universitätsklinikum Köln (AöR)Cologne, GermanyRecruiting
Thoraxklinik-Heidelberg gGmbH am Universitätsklinikum HeidelbergHeidelberg, GermanyRecruiting
Kindai University HospitalOsaka, Sakai, JapanRecruiting
National Cancer Center HospitalTokyo, Chuo-ku, JapanRecruiting
Severance HospitalSeoul, South KoreaNot Yet Recruiting

+ 5 more locations — full list on the registry record.

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Source record: clinicaltrials.gov/study/NCT07486817