TROPION-Urothelial03
Study of Datopotamab Deruxtecan Plus Carboplatin or Cisplatin Versus Gemcitabine Plus Carboplatin or Cisplatin in Participants With Locally Advanced or Metastatic Urothelial Carcinoma
- NCT07129993 ↗
- Recruiting
- Daiichi Sankyo
- Focused
We haven't built an HCP commentary report on TROPION-Urothelial03 (datopotamab deruxtecan in advanced urothelial carcinoma after enfortumab vedotin plus pembrolizumab) yet. This page shows the registry record and the public commentary we found that names the trial. A report reads that commentary and sets out what clinicians said about the trial, each point linked to its source. How reports are made.
Indexed commentary on TROPION-Urothelial03 so far
Podcasts, YouTube videos and X posts we have indexed that name the trial. It is where a report starts, not where it ends: the build searches for more, so finished reports usually cover more than this.
| Channel | Indexed | |
|---|---|---|
| X threads | 4 |
The trial
ClinicalTrials.gov- 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)
- Phase
- Phase 2/Phase 3
- Status
- Recruiting
- Conditions
- Urothelial Cancer; Bladder Cancer
- Interventions
- Dato-DXd; Carboplatin; Cisplatin; Gemcitabine
- Arms
- Part A (Phase 2): Dato-DXd, 4 mg/kg with Platinum · Experimental
- Part A (Phase 2): Dato-DXd, 6 mg/kg with Platinum · Experimental
- Part B (Phase 3): Dato-DXd, RP3D with Platinum · Experimental
- Part B (Phase 3): Gemcitabine with Platinum · Active comparator
- Enrollment
- 630 (estimated)
- Primary outcomes
- Overall Response Rate - Part A (Phase 2)
- Progression Free Survival as Assessed by Blinded Independent Central Review (BICR) - Part B (Phase 3)
- Overall Survival - Part B (Phase 3)
- Sponsor
- Daiichi Sankyo with AstraZeneca
- Start
- Sep 26, 2025
- Primary completion
- Jun 1, 2029 (estimated)
- Results posted
- No
- Registry record
- NCT07129993 · updated Aug 20, 2026
Publications
linked from the registry- 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. PubMed 42142358