Beamion LUNG-3: Adjuvant Zongertinib vs Standard Treatment in People With Completely Resected Stage II-IIIB NSCLC Harboring Activating HER2 TKD Mutations

Prior treatment

• Major surgery (major according to the investigator's assessment) performed within 4 weeks prior to randomization
• Treatment with radiation therapy for primary NSCLC
• Any investigational drug within 5 half-lives of the compound or any of its related material, if known

Lab values

• Co-occurring actionable mutation with approved targeted therapy (e.g. Epidermal growth factor receptor (EGFR) or Anaplastic lymphoma kinase (ALK))
• History or presence of
  • Active or known pre-existing or history of non-infectious interstitial lung disease/pneumonitis
  • Active infectious disease requiring systemic therapy
  • Uncontrolled gastrointestinal disorders affecting drug intake/absorption
  • Previous or concomitant malignancies within the last 3 years, except certain effectively treated cancers
  • Significant and/or uncontrolled cardiovascular abnormalities, QT interval corrected for heart rate by Fridericia formula (QTcF) \>470 msec, or ejection fraction \<50% Further exclusion criteria apply.

Other

• Diagnosis of NSCLC with mixed histology/positive neuroendocrine markers (synaptophysin/CD56)

• 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.