{"entity":{"id":"nct05215340","kind":"trial","name":"Study of Dato-DXd Plus Pembrolizumab vs Pembrolizumab Alone in the First-line Treatment of Subjects With Advanced or Metastatic NSCLC Without Actionab","aka":["TROPION-Lung08"],"tldr":"A phase 3 trial of Datopotamab deruxtecan, Pembrolizumab in non-small-cell lung cancer and small-cell lung cancer, run by Daiichi Sankyo, active and no longer recruiting.","summary":"Study of Dato-DXd Plus Pembrolizumab vs Pembrolizumab Alone in the First-line Treatment of Subjects With Advanced or Metastatic NSCLC Without Actionable Genomic Alterations. ClinicalTrials.gov record last updated 2026-09-24: active not recruiting. Enrollment is actual at 740 participants. Primary completion is estimated at 2030-03-04. No tabular results are posted on ClinicalTrials.gov; this does not exclude separate publications. Registered interventions: Datopotamab Deruxtecan, Pembrolizumab. Registered primary measures: Progression-free Survival Based on Blinded Independent Central Review in Participants With Non-Squamous Histology Who Were Administered Dato-DXd in Combination With Pembrolizumab Compared With Pembrolizumab; Overall Survival (OS) in Participants With Non-Squamous Histology Who Were Administered Dato-DXd in Combination With Pembrolizumab Compared With Pembrolizumab.","status":"active","asOf":"2026-10-06","links":[{"label":"ClinicalTrials.gov NCT05215340","url":"https://clinicaltrials.gov/study/NCT05215340"}],"tags":["ctgov-ingest"],"related":[],"cancers":["nsclc","sclc","pdl1-high-nsclc"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":["trop2"],"drugs":["datopotamab-deruxtecan","pembrolizumab"],"companies":["daiichi-sankyo"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":["ClinicalTrials.gov record last updated 2026-09-24: active not recruiting. Enrollment is actual at 740 participants. Primary completion is estimated at 2030-03-04. No tabular results are posted on ClinicalTrials.gov; this does not exclude separate publications."],"nct":"NCT05215340","phase":"3","setting":"Study of Dato-DXd Plus Pembrolizumab vs Pembrolizumab Alone in the First-line Treatment of Subjects With Advanced or Metastatic NSCLC Without Actionable Genomic Alterations","sponsor":"Daiichi Sankyo","participation":[{"nct":"NCT05215340","source":"https://clinicaltrials.gov/study/NCT05215340","fetchedAt":"2026-10-07T16:53:37.286Z","studySha256":"f08dc0b6001a5ebcb74df5f13d1264f990a3a532216bc2c7b75789f3d73053ed","overallStatus":"ACTIVE_NOT_RECRUITING","lastUpdatePosted":"2026-09-24","leadSponsor":"Daiichi Sankyo","collaboratorCount":2,"minimumAge":"18 Years","sex":"ALL","healthyVolunteers":false,"hasEligibility":true,"enrolment":740,"enrolmentType":"ACTUAL","siteCount":234,"recruitingSiteCount":0,"countries":["Argentina","Australia","Austria","Belgium","Brazil","Canada","Chile","China","France","Germany","Greece","Hong Kong","Hungary","Italy","Japan","Mexico","Netherlands","Poland","Portugal","Romania","South Korea","Spain","Switzerland","Taiwan","Thailand","Turkey (Türkiye)","United Kingdom","United States"]}],"started":"2022-03-04","startedType":"actual","enrolled":740,"enrolledBasis":"registry","outcomes":[]},"route":"/trials/nct05215340/","neighbours":{"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/"},{"id":"sclc","kind":"cancer","name":"Small-cell lung cancer","route":"/cancers/sclc/"}],"technology":[{"id":"checkpoint-inhibitor","kind":"technology","name":"Immune checkpoint inhibitors","route":"/technologies/checkpoint-inhibitor/"}],"target":[{"id":"trop2","kind":"target","name":"TROP2","route":"/targets/trop2/"}],"drug":[{"id":"datopotamab-deruxtecan","kind":"drug","name":"Datopotamab deruxtecan","route":"/drugs/datopotamab-deruxtecan/"},{"id":"pembrolizumab","kind":"drug","name":"Pembrolizumab","route":"/drugs/pembrolizumab/"}],"company":[{"id":"daiichi-sankyo","kind":"company","name":"Daiichi Sankyo","route":"/companies/daiichi-sankyo/"}]}}