Lung Cancer Clinical Trials

• Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial

• Patients must be ≥18 years old or over the legal age of consent in their country

• 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

• HER2 mutation: Documented Tyrosine kinase domain (TKD) activating Human epidermal growth factor receptor 2 (HER2) mutations

• Histology and tumor sample: Histologically confirmed diagnosis of primary NSCLC

• An archival tumor tissue sample must be submitted to the central laboratory after inclusion of the patient to retrospectively confirm the HER2 status

• Staging: Pretherapeutic classification not exceeding Stage IIIB

• 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.