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Clinical trial

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)

NCT07129993 is registered in ClinicalTrials.gov with Daiichi Sankyo as lead sponsor.

NCT NCT07129993
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Registry record

As filed in ClinicalTrials.gov.

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)
Lead sponsor
Daiichi Sankyo
Phase
Phase 2/3
Overall status
Recruiting
Start date
September 26, 2025
Completion date
January 22, 2030
Enrollment
630 (estimated)
Sites
100

Conditions

As the registry lists them; a condition with its own page is linked.

bladder cancer, urothelial cancer