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

Inclusion criteria:

1. Signed and dated written informed consent in accordance with ICH-GCP and locallegislation 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 andable to use dual highly effective methods of birth control per ICH M3 (R2) thatresult in a low failure rate of less than 1% per year when used consistently andcorrectly. A list of contraception methods meeting these criteria is provided in thepatient information and in the study protocol

4. HER2 mutation: Documented Tyrosine kinase domain (TKD) activating Human epidermalgrowth 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 afterinclusion 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 criteriaapply.

Exclusion criteria:

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

2. Major surgery (major according to the investigator's assessment) performed within 4weeks prior to randomization

3. Treatment with radiation therapy for primary NSCLC

4. Co-occurring actionable mutation with approved targeted therapy (e.g. Epidermalgrowth factor receptor (EGFR) or Anaplastic lymphoma kinase (ALK))

5. Any investigational drug within 5 half-lives of the compound or any of its relatedmaterial, if known

6. History or presence of

• Active or known pre-existing or history of non-infectious interstitial lungdisease/pneumonitis

• Active infectious disease requiring systemic therapy

• Uncontrolled gastrointestinal disorders affecting drug intake/absorption

• Previous or concomitant malignancies within the last 3 years, except certaineffectively treated cancers

• Significant and/or uncontrolled cardiovascular abnormalities, QT intervalcorrected for heart rate by Fridericia formula (QTcF) >470 msec, or ejectionfraction <50% Further exclusion criteria apply.