# Beamion LUNG-1

Source: https://onco.cc/trials/beamion-lung-1/  
OnCo record `beamion-lung-1` (Trial). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

Beamion LUNG-1 showed that zongertinib, a pill that blocks mutant HER2 while sparing EGFR, shrinks about seven in ten HER2-mutant lung cancers after chemotherapy, and it became the first oral HER2 drug approved for lung cancer.

## Summary

Beamion LUNG-1 enrolled patients with advanced HER2-mutant non-small-cell lung cancer into a dose-finding phase and then expansion cohorts: previously treated patients naive to HER2-directed therapy, patients who had received a HER2 antibody-drug conjugate, and patients with non-tyrosine-kinase-domain mutations. Earlier HER2 inhibitors such as poziotinib and pyrotinib had produced modest responses with heavy EGFR-mediated diarrhoea and rash.

In the primary cohort of 75 previously treated patients the confirmed response rate was 71 percent, and 48 percent in 31 patients who had already received a HER2 antibody-drug conjugate. Diarrhoea and rash were mostly low grade and liver enzyme rises were the main reason for dose changes; interstitial lung disease was rare.

The FDA granted accelerated approval to zongertinib in August 2025 for previously treated HER2-mutant lung cancer. Beamion LUNG-2 is comparing it with standard first-line chemoimmunotherapy.

## Fields

- Kind: Trial
- Status: positive
- Last checked: 2026-09-17
- Registry id: NCT04886804
- Phase: 1/2
- Setting: Previously treated advanced HER2 (ERBB2)-mutant non-small-cell lung cancer: zongertinib, an oral HER2-selective tyrosine kinase inhibitor, in cohorts by prior HER2-directed therapy
- Sponsor: Boehringer Ingelheim
- Result: Confirmed response rate 71% in 75 previously treated patients naive to HER2-directed therapy; 48% after a HER2 antibody-drug conjugate; FDA accelerated approval August 2025.
- Outcomes: Confirmed objective response rate: Zongertinib, previously treated, no prior HER2-directed therapy 71% vs Zongertinib after a HER2 antibody-drug conjugate 48%
- Replication: SOHO-01 (sevabertinib) reported high response rates with a second HER2-selective inhibitor; Beamion LUNG-2 (NCT06151574) is the confirmatory trial.

## Sources

- ClinicalTrials.gov NCT04886804: https://clinicaltrials.gov/study/NCT04886804
- New England Journal of Medicine 2025: https://doi.org/10.1056/NEJMoa2503704

## Connected records

- cancers: [HER2-mutant non-small-cell lung cancer](https://onco.cc/cancers/her2-mutant-nsclc/), [Non-small-cell lung cancer](https://onco.cc/cancers/nsclc/)
- technologies: [HER2 tyrosine kinase inhibitors](https://onco.cc/technologies/her2-tyrosine-kinase-inhibitors/), [Small-molecule kinase inhibitors](https://onco.cc/technologies/kinase-inhibitors/)
- targets: [HER2](https://onco.cc/targets/her2/)
- drugs: [Trastuzumab deruxtecan](https://onco.cc/drugs/trastuzumab-deruxtecan/), [Zongertinib](https://onco.cc/drugs/zongertinib/)
- companies: [Boehringer Ingelheim](https://onco.cc/companies/boehringer-ingelheim/)
- terms: [Hepatotoxicity (liver enzyme elevation)](https://onco.cc/terms/hepatotoxicity/)
- people: [John V. Heymach](https://onco.cc/people/john-heymach/)

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