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

NCT06088290 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 455

Last updated 2026-05-15

No results posted yet for this study

Summary

The primary objective of this phase III study 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.

Conditions

  • Leiomyosarcoma

Interventions

DRUG

Lurbinectedin

IV Infusion

DRUG

Doxorubicin

Short IV push or bolus (according to label)

Sponsors & Collaborators

  • PharmaMar

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-09-21
Primary Completion
2029-08-30
Completion
2029-08-30
FDA Drug
Yes

Countries

  • United States
  • Austria
  • Belgium
  • France
  • Germany
  • Italy
  • Netherlands
  • Poland
  • Portugal
  • Spain
  • Switzerland
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06088290 on ClinicalTrials.gov