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 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

Trial Details

NCT ID
NCT07486817
Phase
PHASE2
Sponsor
Boehringer Ingelheim
Status
RECRUITING
Cancer Type
Lung Cancer
Interventions
  • Zongertinib
  • Cisplatin
  • Carboplatin
  • Pemetrexed
  • Pembrolizumab
Locations (sample)
  • St Leonards, New South Wales, Australia|-33.82344,151.19836
  • Malvern, Victoria, Australia|-37.86259,145.02811
  • Murdoch, Western Australia, Australia|-32.06987,115.83757
  • Guangzhou, China|23.11667,113.25
  • Shanghai, China|31.22222,121.45806

Key Eligibility Criteria

  • Patients ≥18 years of age or over the legal age of consent in countries where that is greater than 18 years at the time of signature of the informe…
  • Histologically or cytologically confirmed diagnosis of an advanced and/or metastatic non-squamous non-small cell lung cancer (NSCLC)
  • Documented activating human epidermal growth factor receptor 2 (HER2) mutation as per existing local lab result
  • An archival tumor tissue sample must be submitted to the central laboratory after randomization to retrospectively confirm the HER2 status

For full eligibility, visit ClinicalTrials.gov.

Check If You May Be Eligible

Trialify translates complex eligibility criteria into plain yes-or-no questions to help you understand if this trial might be right for you.

Find Lung Cancer Trials on Trialify →