# Beamion LUNG-1: zongertinib in previously treated HER2-mutant non-small-cell lung cancer

Source: https://onco.cc/key-papers/paper-beamion-lung-1-zongertinib-nejm-2025/  
OnCo record `paper-beamion-lung-1-zongertinib-nejm-2025` (Key paper). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

The oral HER2-selective kinase inhibitor zongertinib shrank tumours in about seven in ten patients with previously treated HER2-mutant lung cancer with little of the diarrhoea and rash that plagued earlier HER2 pills, becoming the first oral drug approved for this driver.

## Summary

Phase 1a/1b study; the primary cohort treated 75 patients with previously treated HER2 tyrosine kinase domain-mutant advanced non-small-cell lung cancer with zongertinib 120 mg daily.

Objective response was 71 percent with a median progression-free survival of 12.4 months, intracranial activity in patients with brain metastases, and mainly low-grade diarrhoea and rash; a separate cohort showed activity after prior trastuzumab deruxtecan.

## Fields

- Kind: Key paper
- Last checked: 2026-09-17
- Journal: New England Journal of Medicine
- Year: 2025
- DOI: 10.1056/NEJMoa2503704
- Authors: Heymach JV, Ruiter G, Ahn MJ, et al.
- Findings: Objective response 71 percent.; Median progression-free survival 12.4 months.
- What it means: Zongertinib gives HER2-mutant lung cancer an oral targeted option with brain activity, used after platinum chemotherapy and increasingly before or after trastuzumab deruxtecan.
- Caveats: Single-arm phase 1 data; first-line trials against chemo-immunotherapy are ongoing.

## Sources

- N Engl J Med 2025: https://doi.org/10.1056/NEJMoa2503704
- PubMed: https://pubmed.ncbi.nlm.nih.gov/40293180/

## Connected records

- cancers: [HER2-mutant non-small-cell lung cancer](https://onco.cc/cancers/her2-mutant-nsclc/)
- drugs: [Zongertinib](https://onco.cc/drugs/zongertinib/)
- trials: [Beamion LUNG-1](https://onco.cc/trials/beamion-lung-1/)
- journals: [New England Journal of Medicine](https://onco.cc/journals/nejm/)

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