{"entity":{"id":"tropion-lung01","kind":"trial","name":"TROPION-Lung01","aka":[],"tldr":"A TROP2 ADC helped in non-squamous lung cancer but not squamous, and the overall survival result fell short.","summary":"TROPION-Lung01, trial NCT04656652 sponsored by AstraZeneca and Daiichi Sankyo and reported in 2023, found that the TROP2 antibody-drug conjugate datopotamab deruxtecan helped in previously treated non-squamous non-small-cell lung cancer but not in squamous disease, and that the overall survival result fell short. It randomised 604 patients to datopotamab deruxtecan or docetaxel, met its primary progression-free survival endpoint with a modest effect driven by the non-squamous subgroup, while overall survival, also a primary endpoint, was not significantly different. It led to a narrowed EGFR-mutant approval based on TROPION-Lung05 rather than an all-comers indication, and whether TROP2 ADCs have a place in lung cancer without a driver mutation is the open question.","status":"mixed","asOf":"2026-09-04","links":[{"label":"ClinicalTrials.gov NCT04656652","url":"https://clinicaltrials.gov/study/NCT04656652"}],"tags":[],"related":[],"cancers":["nsclc","pdl1-high-nsclc"],"sections":[],"technologies":["adc","topoisomerase-inhibitors"],"targets":[],"drugs":["datopotamab-deruxtecan"],"companies":["astrazeneca","daiichi-sankyo"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":["benjamin-besse"],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04656652","phase":"3","setting":"Previously treated advanced NSCLC: Dato-DXd vs docetaxel","sponsor":"AstraZeneca / Daiichi Sankyo","result":"PFS HR 0.75; OS HR 0.94.","started":"2020-12-21","startedType":"actual","yearReported":2023,"enrolled":605,"enrolledBasis":"registry","outcomes":[{"endpoint":"Progression-free survival (BICR)","primary":true,"unit":"months","arms":[{"name":"Datopotamab deruxtecan","n":299,"value":4.4},{"name":"Docetaxel","n":305,"value":3.7}],"hr":0.75,"ci":[0.62,0.91],"p":"0.004","source":"https://ascopubs.org/doi/10.1200/JCO.24.01544"},{"endpoint":"Overall survival","primary":true,"unit":"months","arms":[{"name":"Datopotamab deruxtecan","value":12.9,"note":"Not significant"},{"name":"Docetaxel","value":11.8}],"hr":0.94,"ci":[0.78,1.14],"source":"https://ascopubs.org/doi/10.1200/JCO.24.01544"},{"endpoint":"Progression-free survival, non-squamous","unit":"months","arms":[{"name":"Datopotamab deruxtecan","value":5.5},{"name":"Docetaxel","value":3.6}],"hr":0.63,"ci":[0.51,0.79],"source":"https://ascopubs.org/doi/10.1200/JCO.24.01544"}],"replication":"Mixed result; the approval that followed was narrowed to EGFR-mutant NSCLC on the basis of TROPION-Lung05 (single-arm), not this trial."},"route":"/trials/tropion-lung01/","neighbours":{"cancer":[{"id":"lung-adenocarcinoma","kind":"cancer","name":"Adenocarcinoma of the lung","route":"/cancers/lung-adenocarcinoma/"},{"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/"},{"id":"pdl1-high-nsclc","kind":"cancer","name":"PD-L1-high non-small-cell lung cancer without a driver mutation","route":"/cancers/pdl1-high-nsclc/"}],"technology":[{"id":"adc","kind":"technology","name":"Antibody-drug conjugate (ADC)","route":"/technologies/adc/"},{"id":"topoisomerase-inhibitors","kind":"technology","name":"Topoisomerase-I inhibitors (and ADC payloads)","route":"/technologies/topoisomerase-inhibitors/"}],"drug":[{"id":"datopotamab-deruxtecan","kind":"drug","name":"Datopotamab deruxtecan","route":"/drugs/datopotamab-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":"benjamin-besse","kind":"person","name":"Benjamin Besse","route":"/people/benjamin-besse/"}],"trial":[{"id":"tropion-lung05","kind":"trial","name":"TROPION-Lung05","route":"/trials/tropion-lung05/"}],"roadmap":[{"id":"trop2-adc-roadmap","kind":"roadmap","name":"TROP2 ADC roadmap: sacituzumab govitecan → Dato-DXd → sac-TMT → bispecifics and PET","route":"/roadmaps/trop2-adc-roadmap/"}],"idea":[{"id":"idea-trop2-pet-selection","kind":"idea","name":"TROP2 PET to choose and sequence TROP2 ADCs","route":"/ideas/idea-trop2-pet-selection/"}]}}