Beamion LUNG-3: A Study to Test Whether Zongertinib Helps People With Surgically Removed, Non-small Cell Lung Cancer With HER2 Mutations Compared With Standard Treatment

Inclusion Criteria

• •1. Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial
• •2. Patients must be ≥18 years old or over the legal age of consent in their country
• •3. Male or female patients. Women of childbearing potential (WOCBP) must be ready and able to use dual highly effective methods of birth control per ICH M3 (R2) that result in a low failure rate of less than 1% per year when used consistently and correctly. A list of contraception methods meeting these criteria is provided in the patient information and in the study protocol
• •4. HER2 mutation: Documented Tyrosine kinase domain (TKD) activating Human epidermal growth factor receptor 2 (HER2) mutations
• •5. Histology and tumor sample: Histologically confirmed diagnosis of primary NSCLC
• •6. An archival tumor tissue sample must be submitted to the central laboratory after inclusion of the patient to retrospectively confirm the HER2 status
• •7. Staging: Pretherapeutic classification not exceeding Stage IIIB
• •8. Performance status and organ function:
• •* Eastern Cooperative Oncology Group (ECOG) score of 0 or 1