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Randomized, Controlled, Open-label, Phase III Study of Lurbinectedin in Combination With Doxorubicin Versus Doxorubicin Alone as First-line Treatment in Patients With Metastatic Leiomyosarcoma

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Trial Profile

Randomized, Controlled, Open-label, Phase III Study of Lurbinectedin in Combination With Doxorubicin Versus Doxorubicin Alone as First-line Treatment in Patients With Metastatic Leiomyosarcoma

Status: Recruiting
Phase of Trial: Phase III

Latest Information Update: 14 Feb 2026

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At a glance

  • Drugs Doxorubicin (Primary) ; Lurbinectedin (Primary) ; Dexamethasone; Filgrastim; Ondansetron
  • Indications Leiomyosarcoma
  • Focus Therapeutic Use
  • Acronyms SaLuDo
  • Sponsors PharmaMar

Most Recent Events

  • 17 Aug 2025 Protocol has been amended to change phase from phase II/ III to phase III and patient number increased to 450.
  • 17 Aug 2025 Planned number of patients changed from 360 to 450.
  • 17 Aug 2025 Planned End Date changed from 26 Nov 2026 to 30 Aug 2029.

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