{"entity":{"id":"beamion-lung-1","kind":"trial","name":"Beamion LUNG-1","aka":[],"tldr":"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.\n\nIn 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.\n\nThe 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.","status":"positive","asOf":"2026-09-17","links":[{"label":"ClinicalTrials.gov NCT04886804","url":"https://clinicaltrials.gov/study/NCT04886804"},{"label":"New England Journal of Medicine 2025","url":"https://doi.org/10.1056/NEJMoa2503704"}],"tags":[],"related":[],"cancers":["nsclc","her2-mutant-nsclc"],"sections":[],"technologies":["kinase-inhibitors","her2-tyrosine-kinase-inhibitors"],"targets":["her2"],"drugs":["zongertinib","trastuzumab-deruxtecan"],"companies":["boehringer-ingelheim"],"institutions":[],"pathways":[],"terms":["hepatotoxicity"],"trials":[],"people":["john-heymach"],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"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.","yearReported":2025,"outcomes":[{"endpoint":"Confirmed objective response rate","primary":true,"unit":"%","arms":[{"name":"Zongertinib, previously treated, no prior HER2-directed therapy","n":75,"value":71},{"name":"Zongertinib after a HER2 antibody-drug conjugate","n":31,"value":48}],"source":"https://doi.org/10.1056/NEJMoa2503704"}],"replication":"SOHO-01 (sevabertinib) reported high response rates with a second HER2-selective inhibitor; Beamion LUNG-2 (NCT06151574) is the confirmatory trial."},"route":"/trials/beamion-lung-1/","neighbours":{"cancer":[{"id":"her2-mutant-nsclc","kind":"cancer","name":"HER2-mutant non-small-cell lung cancer","route":"/cancers/her2-mutant-nsclc/"},{"id":"nsclc","kind":"cancer","name":"Non-small-cell lung cancer","route":"/cancers/nsclc/"}],"technology":[{"id":"her2-tyrosine-kinase-inhibitors","kind":"technology","name":"HER2 tyrosine kinase inhibitors","route":"/technologies/her2-tyrosine-kinase-inhibitors/"},{"id":"kinase-inhibitors","kind":"technology","name":"Small-molecule kinase inhibitors","route":"/technologies/kinase-inhibitors/"}],"target":[{"id":"her2","kind":"target","name":"HER2","route":"/targets/her2/"}],"drug":[{"id":"trastuzumab-deruxtecan","kind":"drug","name":"Trastuzumab deruxtecan","route":"/drugs/trastuzumab-deruxtecan/"},{"id":"zongertinib","kind":"drug","name":"Zongertinib","route":"/drugs/zongertinib/"}],"company":[{"id":"boehringer-ingelheim","kind":"company","name":"Boehringer Ingelheim","route":"/companies/boehringer-ingelheim/"}],"term":[{"id":"hepatotoxicity","kind":"term","name":"Hepatotoxicity (liver enzyme elevation)","route":"/terms/hepatotoxicity/"}],"person":[{"id":"john-heymach","kind":"person","name":"John V. Heymach","route":"/people/john-heymach/"}]}}