Beamion LUNG-3 study evaluates whether zongertinib, an oral HER2-targeted treatment, can improve outcomes compared with standard adjuvant treatment in adults with completely resected Stage II-IIIB non-small cell lung cancer (NSCLC) whose tumors have activating HER2 tyrosine kinase domain (TKD) mutations. Eligible participants must have undergone curative-intent surgery and received guideline-appropriate perioperative systemic therapy, either neoadjuvant platinum-based chemotherapy with or without immunotherapy, or adjuvant platinum-based chemotherapy.
Participants are randomized 1:1 to receive zongertinib or standard of care, which may consist of approved adjuvant immunotherapy or active surveillance, based on local practice guidelines. The main purpose of the study is to determine whether zongertinib can prolong disease-free survival compared to standard treatment. Safety and patient-reported outcomes are also assessed.
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
Diagnosis of NSCLC with mixed histology/positive neuroendocrine markers (synaptophysin/CD56)
Major surgery (major according to the investigator's assessment) performed within 4 weeks prior to randomization
Treatment with radiation therapy for primary NSCLC
Co-occurring actionable mutation with approved targeted therapy (e.g. Epidermal growth factor receptor (EGFR) or Anaplastic lymphoma kinase (ALK))
Parallel
Zongertinib
DrugZongertinib
Pembrolizumab
DrugPembrolizumab
Atezolizumab
DrugAtezolizumab
Durvalumab
DrugDurvalumab
Nivolumab
DrugNivolumab
Disease-free survival (DFS) by investigator's assessment
DFS is defined as the time from randomization until recurrence of tumor or death from any cause, whichever occurs earlier
Key secondary endpoint: Overall survival (OS), defined as the time from randomization until death from any cause
Occurrence of trial-related Adverse Events (AEs) ≥ Grade 3 from first treatment administration (or from randomization for patients in the observation arm) until the earliest of tumor recurrence or 3 years since treatment start
AEs are graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 5.0
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