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

Summary

Objectives

This is a global, randomized, open-label, Phase 3 study designed to assess the efficacy
and safety of zongertinib as adjuvant therapy in participants with completely resected
Stage II-IIIB NSCLC and HER2 TKD-activating mutations.

Participants must have undergone complete resection and received perioperative systemic
therapy consistent with current standards, including either neoadjuvant platinum-based
chemotherapy with or without immunotherapy, or adjuvant platinum-based chemotherapy.

After completing surgery and required systemic treatment, eligible participants are
randomized 1:1 to receive either Zongertinib taken orally once daily for up to 3 years,
or standard treatment, which may include an approved adjuvant immunotherapy agent
administered according to its label, or observation, depending on local clinical practice
and patient status.

The primary objective is to evaluate whether zongertinib improves disease-free survival
(DFS) compared with standard treatment. Secondary objectives include overall survival
(OS), safety, tolerability, and patient-reported outcomes.