{"entity":{"id":"destiny-lung01","kind":"trial","name":"DESTINY-Lung01","aka":[],"tldr":"DESTINY-Lung01 showed that the antibody-drug conjugate trastuzumab deruxtecan shrank tumours in more than half of people whose lung cancer carried a HER2 mutation, which led to the first approved HER2-targeted treatment for lung cancer.","summary":"DESTINY-Lung01 was a two-cohort phase 2 study of trastuzumab deruxtecan, an antibody-drug conjugate that delivers a topoisomerase I inhibitor to HER2-expressing cells, in metastatic non-small-cell lung cancer that had progressed on standard therapy. One cohort enrolled HER2-mutant tumours and the other HER2-overexpressing tumours.\n\nIn the HER2-mutant cohort the drug produced responses in a majority of patients with durable disease control, including in the brain. Interstitial lung disease was the toxicity that needed monitoring. The result led to accelerated approval in the United States in August 2022 for HER2-mutant non-small-cell lung cancer after prior systemic therapy, the first HER2-directed approval in lung cancer. The HER2-overexpressing cohort showed lower activity.","status":"positive","asOf":"2026-09-17","links":[{"label":"ClinicalTrials.gov NCT03505710","url":"https://clinicaltrials.gov/study/NCT03505710"}],"tags":["subtype-trials"],"related":[],"cancers":["her2-mutant-nsclc","nsclc","lung-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":["trastuzumab-deruxtecan"],"companies":["daiichi-sankyo","astrazeneca"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":["bob-li"],"bottlenecks":[],"keyPapers":["paper-destiny-lung01-nejm-2022"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03505710","phase":"2","setting":"Previously treated HER2-mutant or HER2-overexpressing metastatic non-small-cell lung cancer: single-arm trastuzumab deruxtecan","sponsor":"Daiichi Sankyo","result":"High response rate with durable responses in HER2-mutant non-small-cell lung cancer; accelerated approval in August 2022.","yearReported":2022,"enrolled":181,"outcomes":[]},"route":"/trials/destiny-lung01/","neighbours":{"cancer":[{"id":"her2-mutant-nsclc","kind":"cancer","name":"HER2-mutant non-small-cell lung cancer","route":"/cancers/her2-mutant-nsclc/"},{"id":"lung-cancer","kind":"cancer","name":"Lung cancer (all types)","route":"/cancers/lung-cancer/"},{"id":"nsclc","kind":"cancer","name":"Non-small-cell lung cancer","route":"/cancers/nsclc/"}],"drug":[{"id":"trastuzumab-deruxtecan","kind":"drug","name":"Trastuzumab deruxtecan","route":"/drugs/trastuzumab-deruxtecan/"}],"company":[{"id":"astrazeneca","kind":"company","name":"AstraZeneca","route":"/companies/astrazeneca/"},{"id":"daiichi-sankyo","kind":"company","name":"Daiichi Sankyo","route":"/companies/daiichi-sankyo/"}],"person":[{"id":"bob-li","kind":"person","name":"Bob T. Li","route":"/people/bob-li/"}],"paper":[{"id":"paper-destiny-lung01-nejm-2022","kind":"paper","name":"DESTINY-Lung01: trastuzumab deruxtecan in HER2-mutant non-small-cell lung cancer","route":"/key-papers/paper-destiny-lung01-nejm-2022/"}]}}