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

RECRUITINGPHASE3

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

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

NCT06088290•PharmaMar

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Voluntary signed and dated written informed consent of the participants obtained before any study-specific procedure.
•2. Age ≥ 18 years.
•3. Histologically confirmed diagnosis of metastatic LMS, in participants not candidates for curative resection.
•4. Radiologically measurable disease according to the Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1.
•5. No previous systemic therapy for metastatic disease (i.e., first-line setting) and no previous anthracyclines. Note: prior chemotherapy (without anthracycline) in the context of adjuvant or neoadjuvant therapy is allowed. Prior line/s of hormone therapy in the adjuvant/metastatic setting are also allowed.
•6. Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤ 1.
•7. Adequate hematological, renal, metabolic and hepatic function:
•1. Hemoglobin ≥ 9.0 g/dL (participants may have received prior red blood cell \[Red Blood Cell\] transfusion); absolute neutrophil count (ANC) ≥ 2.0 x 10\^9/L, and platelet count
•≥ 100 x 10\^9/L.
•2. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3.0 x upper limit of normal (ULN).
+9 more criteria

Exclusion Criteria

•1. Prior treatment with anthracyclines, lurbinectedin or trabectedin.
•2. Known low grade leiomyosarcoma (i.e., grade I).
•3. Known hypersensitivity to any of the components of the IV formulation of lurbinectedin or doxorubicin.
•4. Concomitant diseases/conditions:
•1. History of cardiac disease: myocardial infarction or angina within the year prior to enrollment; severe vascular disease; or symptomatic arrhythmia despite ongoing treatment.
•2. Participants with any immunodeficiency, including those known to be infected by human immunodeficiency virus (HIV).
•3. Known chronic active hepatitis or cirrhosis. For Hepatitis B, this includes positive tests for both Hepatitis B surface antigen and quantitative Hepatitis B polymerase chain reaction (PCR). For Hepatitis C, this includes positive tests for both Hepatitis C antibody and quantitative Hepatitis C PCR.
•4. Active uncontrolled infection.
•5. Any other major illness that (including severe cardiovascular disease) or risk factors that, in the Investigator's judgment, will substantially increase the risk associated with the patient's participation in this study.
•5. Use of strong inducers of CYP3A4 activity within two weeks prior to the first infusion of lurbinectedin.
+6 more criteria

Locations (94)

Mayo Clinic Hospital - Phoenix

Phoenix, Arizona, United States

Precision NextGen Oncology & Research Center

Beverly Hills, California, United States

Cedars-Sinai Medical Center

Los Angeles, California, United States

Norris Comprehensive Cancer Center

Los Angeles, California, United States

Sarcoma Oncology Center

Los Angeles, California, United States

Stanford University (Leland Stanford Junior University)

Palo Alto, California, United States

University of Colorado Hospital - Anschutz Medical Campus

Aurora, Colorado, United States

Mayo Clinic - Jacksonville

Jacksonville, Florida, United States

Moffitt Cancer Center

Tampa, Florida, United States

Augusta University Georgia Cancer Center

Augusta, Georgia, United States

Key Dates

Start Date

September 21, 2023

Primary Completion Date

August 30, 2029

Completion Date

August 30, 2029

Last Updated

March 11, 2026

Enrollment

450

ESTIMATED participants

Conditions

Leiomyosarcoma

Interventions

Lurbinectedin

DRUG

Doxorubicin

DRUG

Contacts

Gaston Federico Boggio, M.D.

CONTACT

+34 91 823 4524 gfboggio@pharmamar.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 11, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

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