{"entity":{"id":"nct06350097","kind":"trial","name":"Phase III, Open-label Study of First-line Osimertinib With or Without Datopotamab Deruxtecan for EGFRm Locally Advanced or Metastatic Non-small Cell L","aka":["TROPION-Lung14"],"tldr":"A phase 3 trial of Osimertinib, Datopotamab deruxtecan in non-small-cell lung cancer and small-cell lung cancer, run by AstraZeneca, now recruiting.","summary":"Phase III, Open-label Study of First-line Osimertinib With or Without Datopotamab Deruxtecan for EGFRm Locally Advanced or Metastatic Non-small Cell Lung Cancer. ClinicalTrials.gov record last updated 2026-08-26: recruiting. Enrollment is planned at 582 participants. Primary completion is estimated at 2028-03-21. No tabular results are posted on ClinicalTrials.gov; this does not exclude separate publications. Registered interventions: Osimertinib, Datopotamab Deruxtecan. Registered primary measures: To demonstrate the superiority of osimertinib in combination with Datopotamab Deruxtecan relative to osimertinib by assessment of Progression Free Survival (PFS) by BICR in all randomised participants..","status":"recruiting","asOf":"2026-10-06","links":[{"label":"ClinicalTrials.gov NCT06350097","url":"https://clinicaltrials.gov/study/NCT06350097"}],"tags":["ctgov-ingest"],"related":[],"cancers":["nsclc","sclc"],"sections":[],"technologies":["adc","kinase-inhibitors","topoisomerase-inhibitors"],"targets":["trop2"],"drugs":["osimertinib","datopotamab-deruxtecan"],"companies":["astrazeneca"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":["ClinicalTrials.gov record last updated 2026-08-26: recruiting. Enrollment is planned at 582 participants. Primary completion is estimated at 2028-03-21. No tabular results are posted on ClinicalTrials.gov; this does not exclude separate publications."],"nct":"NCT06350097","phase":"3","setting":"Phase III, Open-label Study of First-line Osimertinib With or Without Datopotamab Deruxtecan for EGFRm Locally Advanced or Metastatic Non-small Cell Lung Cancer","sponsor":"AstraZeneca","participation":[{"nct":"NCT06350097","source":"https://clinicaltrials.gov/study/NCT06350097","fetchedAt":"2026-10-07T16:54:34.595Z","studySha256":"c9505b9fb9279d6710bfdb5454bb09647cd304aaf2a81e162d43ccd66ecd3cfb","overallStatus":"RECRUITING","lastUpdatePosted":"2026-08-26","leadSponsor":"AstraZeneca","collaboratorCount":1,"minimumAge":"18 Years","sex":"ALL","healthyVolunteers":false,"hasEligibility":true,"enrolment":582,"enrolmentType":"ESTIMATED","siteCount":167,"recruitingSiteCount":133,"countries":["Australia","Brazil","Canada","China","France","Germany","Hong Kong","India","Italy","Japan","Poland","Puerto Rico","South Korea","Spain","Taiwan","Thailand","Turkey (Türkiye)","United States","Vietnam"]}],"started":"2024-04-29","startedType":"actual","enrolled":582,"enrolledBasis":"registry","outcomes":[]},"route":"/trials/nct06350097/","neighbours":{"cancer":[{"id":"nsclc","kind":"cancer","name":"Non-small-cell lung cancer","route":"/cancers/nsclc/"},{"id":"sclc","kind":"cancer","name":"Small-cell lung cancer","route":"/cancers/sclc/"}],"technology":[{"id":"adc","kind":"technology","name":"Antibody-drug conjugate (ADC)","route":"/technologies/adc/"},{"id":"kinase-inhibitors","kind":"technology","name":"Small-molecule kinase inhibitors","route":"/technologies/kinase-inhibitors/"},{"id":"topoisomerase-inhibitors","kind":"technology","name":"Topoisomerase-I inhibitors (and ADC payloads)","route":"/technologies/topoisomerase-inhibitors/"}],"target":[{"id":"trop2","kind":"target","name":"TROP2","route":"/targets/trop2/"}],"drug":[{"id":"datopotamab-deruxtecan","kind":"drug","name":"Datopotamab deruxtecan","route":"/drugs/datopotamab-deruxtecan/"},{"id":"osimertinib","kind":"drug","name":"Osimertinib","route":"/drugs/osimertinib/"}],"company":[{"id":"astrazeneca","kind":"company","name":"AstraZeneca","route":"/companies/astrazeneca/"}]}}