Beamion LUNG-1
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.
Overview
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.
- 71 vs 48 out of 100 had their tumour shrink with Zongertinib, previously treated, no prior HER2-directed therapy compared with Zongertinib after a HER2 antibody-drug conjugate; 23 more per 100.
- Roughly one extra person helped for every 4 treated. That is a rough figure taken from the two percentages, not a guarantee for any one person.
- A response rate counts how many people had their tumours shrink by a set amount; shrinking is encouraging but does not by itself show that people live longer or feel better.
- These results apply to the people the trial enrolled: 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. People in a different situation may not see the same effect.
- The trial selected people by a biomarker (HER2); the result should not be assumed for people whose cancer does not have it.
Numbers are from the trial as recorded here; see the source links in the table below. This is orientation, not medical advice: ask your team how closely the trial population matches you.
| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Confirmed objective response rateprimary | Zongertinib, previously treated, no prior HER2-directed therapy | 75 | 71% | - | - | link |
| Zongertinib after a HER2 antibody-drug conjugate | 31 | 48% |
Similar pages
not linked directly; found by shared links- TreatmentSevabertinib
Shares Zongertinib, HER2-mutant non-small-cell lung cancer, Trastuzumab deruxtecan, HER2.
- TrialBeamion LUNG-2: A Study to Test Whether Zongertinib (BI 1810631) Helps People With Advanced Non-small Cell Lung Cancer With HER2 Mutations Compared With Standard Treatment
Shares Zongertinib, Boehringer Ingelheim, HER2-mutant non-small-cell lung cancer, Non-small-cell lung cancer.
- TrialBeamion 44: A Study to Test How Well Zongertinib is Tolerated by People With Advanced Non-small Cell Lung Cancer With HER2 Mutations When Given in Combination With Chemotherapy With or Without Pembrolizumab
Shares Zongertinib, Boehringer Ingelheim, Non-small-cell lung cancer.
- TrialBeamion PANTUMOR-1: A Study to Test Whether Zongertinib Helps People With Advanced Cancers With HER2 Alterations
Shares Zongertinib, Boehringer Ingelheim.
- TrialBeamion BCGC-1: A Study to Find a Suitable Dose of Zongertinib Used Alone and in Combination With Other Treatments to Test Whether it Helps People Wit
Shares Zongertinib, Boehringer Ingelheim, Trastuzumab deruxtecan.
- TrialBeamion LUNG-3: Adjuvant Zongertinib vs Standard Treatment in People With Completely Resected Stage II-IIIB NSCLC Harboring Activating HER2 TKD Mutati
Shares Zongertinib, Boehringer Ingelheim, Non-small-cell lung cancer.
- TrialDESTINY-Lung02
Shares HER2-mutant non-small-cell lung cancer, Trastuzumab deruxtecan, HER2, Non-small-cell lung cancer.
- TreatmentAfatinib
Shares Boehringer Ingelheim, HER2-mutant non-small-cell lung cancer, HER2, Small-molecule kinase inhibitors.