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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: Active, no longer recruiting
Phase of Trial: Phase III

Latest Information Update: 19 May 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

  • 15 May 2026 Status changed from recruiting to active, no longer recruiting.
  • 27 Feb 2026 According to a Pharmamar media release, the recruitment is expected to be completed in the middle of this year with data expected in the 1st half of 2027.
  • 17 Aug 2025 Protocol has been amended to change phase from phase II/ III to phase III and patient number increased to 450.

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