Evaluating Oral Zongertinib Versus Standard Adjuvant Treatment After Surgery in Adults With Stage II-IIIB Non-Small Cell Lung Cancer Harboring HER2 TKD Mutations

What this Trial Is About

Researchers are evaluating zongertinib, an oral drug targeting HER2 mutations, to see if it can improve outcomes compared with standard adjuvant treatments in adults who have had complete surgical removal of Stage II-IIIB non-small cell lung cancer NSCLC with activating HER2 tyrosine kinase domain mutations. This Phase 3, global, randomized, open-label study involves participants who have already received appropriate perioperative systemic therapy, including neoadjuvant or adjuvant platinum-based chemotherapy, with or without immunotherapy. Participants are randomly assigned in equal numbers to receive either zongertinib once daily by mouth for up to 3 years or standard treatment, which may include approved adjuvant immunotherapy or observation depending on local guidelines and patient status. The study compares disease-free survival between these groups and also monitors safety and patient-reported outcomes. Tumor samples are collected centrally to confirm HER2 status. During the study, participants undergo regular assessments to monitor disease status, safety, and quality of life. The primary outcome is disease-free survival, tracked for up to 8 years and 5 months. Secondary outcomes include overall survival and occurrence of significant adverse events over up to 3 years. Participant involvement may last several years, with follow-up continuing after treatment to assess long-term outcomes and safety.

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