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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 · View on ClinicalTrials.gov ↗
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06088290
The ClinicalTrials.gov registry entry for NCT06088290 describes a study currently listed as recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 450 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is PharmaMar, which has 36 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT06088290 reports 20 study locations spanning 14 distinct geographic areas — top geographies include California, Florida, Massachusetts. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06088290?
The interventions under investigation include: Doxorubicin (DRUG), Lurbinectedin (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06088290?
This trial is sponsored by PharmaMar, which has 36 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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.
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