{"entity":{"id":"tropion-lung05","kind":"trial","name":"TROPION-Lung05","aka":[],"tldr":"The study that got Datroway approved for EGFR-mutant lung cancer after other treatments fail.","summary":"TROPION-Lung05, trial NCT04484142 sponsored by AstraZeneca and Daiichi Sankyo and reported in 2023, is the phase 2 study that supported approval of datopotamab deruxtecan for EGFR-mutant non-small-cell lung cancer after targeted therapy and platinum chemotherapy have failed. It enrolled 137 patients with actionable genomic alterations in a single-arm design, the objective response rate by blinded review was higher in the 78 EGFR-mutant patients than overall, and pooled with EGFR-mutant patients from TROPION-Lung01 the data supported accelerated approval in June 2025. OnCo links it to TROP2 and EGFR as targets and to TROPION-Lung01. As a single-arm phase 2 it cannot show that the drug improves survival over the alternatives, and the randomised TROPION-Lung15 trial will be the confirmatory study. Datopotamab deruxtecan has its own page.","status":"positive","asOf":"2026-09-06","links":[{"label":"ClinicalTrials.gov NCT04484142","url":"https://clinicaltrials.gov/study/NCT04484142"}],"tags":[],"related":[],"cancers":["nsclc","egfr-mutant-nsclc"],"sections":[],"technologies":["adc","topoisomerase-inhibitors"],"targets":["trop2","egfr"],"drugs":["datopotamab-deruxtecan"],"companies":["astrazeneca","daiichi-sankyo"],"institutions":[],"pathways":[],"terms":[],"trials":["tropion-lung01"],"people":[],"bottlenecks":[],"keyPapers":["paper-tropion-lung05-j-clin-oncol-2025"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04484142","phase":"2","setting":"Actionable-genomic-alteration NSCLC after targeted therapy and platinum: datopotamab deruxtecan single arm","sponsor":"AstraZeneca / Daiichi Sankyo","result":"ORR 43.6% in EGFR-mutant disease.","started":"2021-03-30","startedType":"actual","yearReported":2023,"enrolled":137,"enrolledBasis":"registry","outcomes":[{"endpoint":"Objective response rate (BICR)","primary":true,"unit":"%","arms":[{"name":"Datopotamab deruxtecan, all","n":137,"value":35.8},{"name":"EGFR-mutant subgroup","n":78,"value":43.6}],"source":"https://ascopubs.org/doi/10.1200/JCO.24.00821"}],"replication":"Single-arm phase 2 that supported the EGFR-mutant NSCLC approval; TROPION-Lung15 (randomised) will be the confirmatory trial."},"route":"/trials/tropion-lung05/","neighbours":{"cancer":[{"id":"egfr-mutant-nsclc","kind":"cancer","name":"EGFR-mutated non-small-cell lung cancer","route":"/cancers/egfr-mutant-nsclc/"},{"id":"nsclc","kind":"cancer","name":"Non-small-cell lung cancer","route":"/cancers/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/"}],"target":[{"id":"egfr","kind":"target","name":"EGFR","route":"/targets/egfr/"},{"id":"trop2","kind":"target","name":"TROP2","route":"/targets/trop2/"}],"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/"}],"trial":[{"id":"tropion-lung01","kind":"trial","name":"TROPION-Lung01","route":"/trials/tropion-lung01/"}],"paper":[{"id":"paper-tropion-lung05-j-clin-oncol-2025","kind":"paper","name":"Datopotamab Deruxtecan in Advanced or Metastatic Non-Small Cell Lung Cancer With Actionable Genomic Alterations: Results From the Phase II TROPION-Lung05 Study","route":"/key-papers/paper-tropion-lung05-j-clin-oncol-2025/"}]}}