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NCT06088290 · ClinicalTrials.gov registry record · Phase 3
Study of Lurbinectedin in Combination With Doxorubicin Versus Doxorubicin Alone as First-line Treatment in Participants With Metastatic Leiomyosarcoma (SaLuDo)
A Phase 3 study of Leiomyosarcoma, sponsored by PharmaMar.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 450
- Enrollment target
- 20
- Study locations
NCT06088290: Recruiting Phase 3 study of Leiomyosarcoma, sponsored by PharmaMar.
NCT06088290 is a Phase 3 study of Leiomyosarcoma that is actively recruiting participants, run by PharmaMar. The registered enrollment target is 450 participants, above the 94-participant average among 16 other Leiomyosarcoma trials with a reported enrollment target (379% higher). The trial reports 20 study locations across 14 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06088290, a Phase 3 study of Leiomyosarcoma, is actively recruiting participants, sponsored by PharmaMar.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 450 participants
- Enrollment target
- 20
- Study locations
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 Studied
Interventions
- DRUG Doxorubicin
- DRUG Lurbinectedin
Study Locations (20)
California
- Precision NextGen Oncology & Research Center - Beverly Hills
- Cedars-Sinai Medical Center - Los Angeles
- Norris Comprehensive Cancer Center - Los Angeles
- Sarcoma Oncology Center - Los Angeles
- Stanford University (Leland Stanford Junior University) - Palo Alto
Florida
- Mayo Clinic - Jacksonville - Jacksonville
- Moffitt Cancer Center - Tampa
Massachusetts
- Massachusetts General Hospital - Boston
- Dana-Farber Cancer Institute - Boston
Arizona
- Mayo Clinic Hospital - Phoenix - Phoenix
Colorado
- University of Colorado Hospital - Anschutz Medical Campus - Aurora
Georgia
- Augusta University Georgia Cancer Center - Augusta
Michigan
- University of Michigan - Ann Arbor
Minnesota
- Mayo Clinic - Rochester - Rochester
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 450 participants |
| Start Date | 2023-09-21 |
| Est. Completion | 2029-08-30 |
| Phase | Phase 3 |
What NCT06088290 shows while recruiting
NCT06088290 is an interventional study that assigns participants to a tested intervention. The registered 450 participants enrollment target is mid-sized for trials with a published cap, above the 94-participant average among 16 other Leiomyosarcoma trials with a reported enrollment target (379% higher).
The record links to 1 condition, with Leiomyosarcoma appearing as the primary indexed condition, and to 2 interventions - of which Doxorubicin is the first listed.
NCT06088290 names 20 study sites across 14 states, led by California, Florida, Massachusetts.
Frequently Asked Questions
What is clinical trial NCT06088290 about?
NCT06088290 is a clinical study titled "Study of Lurbinectedin in Combination With Doxorubicin Versus Doxorubicin Alone as First-line Treatment in Participants With Metastatic Leiomyosarcoma (SaLuDo)". 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 adm...
What is the current status of trial NCT06088290?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 450 participants. The study started on 2023-09-21. Estimated completion is 2029-08-30.
What conditions does trial NCT06088290 study?
This clinical trial studies the following conditions: Leiomyosarcoma.
What interventions are being tested in trial NCT06088290?
The interventions under investigation include: Doxorubicin (DRUG), Lurbinectedin (DRUG).
Who is sponsoring clinical trial NCT06088290?
This trial is sponsored by PharmaMar, which has 32 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06088290 being conducted?
This trial has 20 study locations across Arizona, California, Colorado, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Leiomyosarcoma
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06088290's enrollment target sits among peer trials
450 1st of 16 higher than 16 of 16 other Leiomyosarcoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Leiomyosarcoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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