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

This study is open to adults 18 years and older who have early-stage non-small cell lung cancer (NSCLC). Their cancer must have a specific change in a gene called HER2. Genes provide the instructions for making proteins, and this change leads to a faulty HER2 protein. People can join if their lung cancer was removed by surgery, and they have already received certain other anti-cancer treatments. The purpose of this study is to find out if a study medicine called zongertinib helps people with this type of cancer live longer…

• : 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 * Adequate organ function based on laboratory values Further inclusion criteria apply.

Use the source registry for the full inclusion and exclusion criteria before discussing referral or enrolment.