Clinical Trial

Study of Lurbinectedin in Combination With Doxorubicin Versus Doxorubicin Alone as First-line Treatment in Participants With Metastatic Leiomyosarcoma (SaLuDo)

Study acronym: SaLuDo
Active, Not Recruiting Phase 3
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Summary
The primary objective of this phase III trial is to evaluate whether the combination of lurbinectedin plus doxorubicin given as first line treatment for metastatic leiomyosarcoma (LMS) prolongs the progression-free survival (PFS) by Independent Review Committee (IRC) when compared to doxorubicin administered as a single agent.
Protocol Amendment History 2 changes
critical Trial status changed: Recruiting → Active, Not Recruiting 2026-05-16
notable Trial sites expanded: 94 -> 97 locations 2026-04-18
Trial Details
NCT Number NCT06088290
Lead Sponsor PharmaMar
Conditions Leiomyosarcoma
Enrollment 469 participants
Start Date 2023-09-21
Primary Completion 2029-08-30 (estimated)
Study Completion 2029-08-30 (estimated)
Updated on ClinicalTrials.gov 2026-06-18