{"preliminary_commentary":{"by_channel":{"x_thread":4},"note":"Preliminary. Indexed podcasts, YouTube videos and X posts that name this trial so far. This is where a report starts, not where it ends: the build searches for more, so finished reports usually cover more than this."},"free_build":{"available":false},"commentary_summary":null,"drugs_tested":[["datopotamab deruxtecan"]],"indication":"advanced urothelial carcinoma after enfortumab vedotin plus pembrolizumab","name":"TROPION-Urothelial03","nct_id":"NCT07129993","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=tropion-urothelial03-nct07129993. The price is an estimate of verified statements from the commentary indexed so far, fixed at order. Final coverage is set when the report is built. We build the report within 24 hours of confirming the order and deliver it when it passes our checks; if it cannot be built to our standard, nothing is charged.","price_usd":750,"size":"focused","size_rule":"Focused: 1–150 verified statements, estimated at 14 per indexed commentary source"},"registry":{"acronym":null,"arms":[{"description":"Participants will receive Dato-DXd in combination with platinum (carboplatin or cisplatin). The RP3D will be determined using data collected from Part A.","label":"Part A (Phase 2): Dato-DXd, 4 mg/kg with Platinum","type":"EXPERIMENTAL"},{"description":"Participants will receive Dato-DXd in combination with platinum (carboplatin or cisplatin). The RP3D will be determined using data collected from Part A.","label":"Part A (Phase 2): Dato-DXd, 6 mg/kg with Platinum","type":"EXPERIMENTAL"},{"description":"Participants will receive Dato-DXd at the RP3D in combination with platinum (carboplatin or cisplatin).","label":"Part B (Phase 3): Dato-DXd, RP3D with Platinum","type":"EXPERIMENTAL"},{"description":"Participants will receive Gemcitabine in combination with platinum (carboplatin or cisplatin).","label":"Part B (Phase 3): Gemcitabine with Platinum","type":"ACTIVE_COMPARATOR"}],"collaborators":["AstraZeneca"],"completion_date":{"date":"2030-01-22","type":"ESTIMATED"},"conditions":["Urothelial Cancer","Bladder Cancer"],"enrollment":{"count":630,"type":"ESTIMATED"},"has_results":false,"interventions":[{"name":"Dato-DXd","otherNames":["Datopotamab Deruxtecan"],"type":"DRUG"},{"name":"Carboplatin","otherNames":[],"type":"DRUG"},{"name":"Cisplatin","otherNames":[],"type":"DRUG"},{"name":"Gemcitabine","otherNames":[],"type":"DRUG"}],"last_update":"2026-08-20","lead_sponsor":"Daiichi Sankyo","official_title":"A Randomized, Open-Label, Phase 2/3 Study of Datopotamab Deruxtecan (Dato-DXd) Plus Carboplatin or Cisplatin Versus Gemcitabine Plus Carboplatin or Cisplatin in Participants With Locally Advanced or Metastatic Urothelial Carcinoma (la/mUC) Who Progressed During or After Enfortumab Vedotin (EV) Plus Pembrolizumab Combination Treatment TROPION-Urothelial03 (TU03)","overall_status":"RECRUITING","phases":["PHASE2","PHASE3"],"primary_completion_date":{"date":"2029-06-01","type":"ESTIMATED"},"primary_outcomes":[{"measure":"Overall Response Rate - Part A (Phase 2)","timeFrame":"From Phase 2 randomization to the first documented radiographic disease progression or death due to any cause, whichever occurs first, up to approximately 34 months"},{"measure":"Progression Free Survival as Assessed by Blinded Independent Central Review (BICR) - Part B (Phase 3)","timeFrame":"From Phase 3 randomization to the first documented radiographic disease progression or death due to any cause, whichever occurs first, up to approximately 38 months"},{"measure":"Overall Survival - Part B (Phase 3)","timeFrame":"From Phase 3 randomization to death due to any cause, up to approximately 38 months"}],"references":[{"citation":"Galsky MD, Drakaki A, Basu A, McGregor B, Bedke J, Loriot Y, Kikuchi E, Guo J, Garmezy B, Sridhar SS, Singh P, Koshkin VS, Fleming M, Klauss G, Lin D, Liu C, Apolo AB, Powles T. TROPION-Urothelial03: a phase II/III study of datopotamab deruxtecan (Dato-DXd) for locally advanced or metastatic urothelial carcinoma. Future Oncol. 2026 May;22(12):1387-1396. doi: 10.1080/14796694.2026.2663956. Epub 2026 May 16.","pmid":"42142358","type":"DERIVED"}],"start_date":{"date":"2025-09-26","type":"ACTUAL"},"study_type":"INTERVENTIONAL","title":"Study of Datopotamab Deruxtecan Plus Carboplatin or Cisplatin Versus Gemcitabine Plus Carboplatin or Cisplatin in Participants With Locally Advanced or Metastatic Urothelial Carcinoma","url":"https://clinicaltrials.gov/study/NCT07129993"},"report":null,"schema_id":"erudio.trial_listing","schema_version":"3.1","state":"listed","state_text":"No report yet. It can be ordered.","url":"https://www.erudio.com/trials/tropion-urothelial03-nct07129993"}