Recruiting

SaLuDoLurbinectedin and Doxorubicin for Metastatic Leiomyosarcoma

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What is being tested

Lurbinectedin

+ Doxorubicin

Drug
Who is being recruted

Leiomyosarcoma+3

+ Neoplasms

+ Neoplasms by Histologic Type

Over 18 Years
+20 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 3
Interventional
Study Start: September 2023
See protocol details

Summary

Principal SponsorPharmaMar
Study ContactGaston Federico Boggio, M.D.
Last updated: March 12, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: September 21, 2023

Actual date on which the first participant was enrolled.

This clinical trial investigates a treatment for people with metastatic leiomyosarcoma, a type of cancer that starts in the smooth muscles and has spread to other parts of the body. The study aims to see if a combination of two drugs, lurbinectedin and doxorubicin, can help patients live longer without their cancer getting worse, compared to using doxorubicin alone. This research is important because finding a more effective first-line treatment could significantly improve the quality of life and survival chances for those affected by this condition. Participants in the study will receive either the combination of lurbinectedin and doxorubicin or just doxorubicin. The drugs will be given according to a schedule set by the researchers, likely through injections, to see which option best controls the cancer's progression. The study carefully monitors how the cancer responds to the treatment, measuring how long it takes before the disease worsens. By comparing these two approaches, the study hopes to determine the best possible treatment plan for patients with this advanced cancer.

Official TitleRandomized, 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
Principal SponsorPharmaMar
Study ContactGaston Federico Boggio, M.D.
Last updated: March 12, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

450 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

LeiomyosarcomaNeoplasmsNeoplasms by Histologic TypeNeoplasms, Muscle TissueSarcomaNeoplasms, Connective and Soft Tissue

Criteria

9 inclusion criteria required to participate
Wash-out periods: At least three weeks since last prior systemic treatment. At least three weeks since last prior major surgery and one week since last prior minor surgery (port placement is excluded from this wash-out period). At least two weeks since last prior radiotherapy.
Voluntary signed and dated written informed consent of the participants obtained before any study-specific procedure.
Age ≥ 18 years.
Histologically confirmed diagnosis of metastatic LMS, in participants not candidates for curative resection.
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11 exclusion criteria prevent from participating
Prior treatment with anthracyclines, lurbinectedin or trabectedin.
Known low grade leiomyosarcoma (i.e., grade I).
Known hypersensitivity to any of the components of the IV formulation of lurbinectedin or doxorubicin.
Use of strong inducers of CYP3A4 activity within two weeks prior to the first infusion of lurbinectedin.
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Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

3 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Participants will receive doxorubicin and lurbinectedin intravenously (IV) every three weeks (q3wk) on Day 1 of each treatment cycle (treatment cycle = three weeks).

Group II

Experimental
Participants will receive doxorubicin IV q3wk on Day 1 of each treatment cycle (treatment cycle = three weeks).

Group III

Active Comparator
Participants will receive doxorubicin IV q3wk on Day 1 of each treatment cycle (treatment cycle = three weeks).

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 94 locations

Recruiting

Institut Curie

Paris, FranceOpen Institut Curie in Google Maps
Recruiting

Centre Hospitalier Universitaire de Poitiers

Poitiers, France
Recruiting

Centre Eugène Marquis

Rennes, France
Recruiting

Institut de Cancérologie de l'Ouest - Saint-Herblain - Site René Gauducheau

Saint-Herblain, France
Recruiting
94 Study Centers