RecruitingPhase 3NCT06088290

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

Sponsor

PharmaMar

Enrollment

450 participants

Start Date

Sep 21, 2023

Study Type

INTERVENTIONAL

Conditions

Leiomyosarcoma

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing two treatment options for advanced leiomyosarcoma (a rare cancer of smooth muscle tissue) that has spread and cannot be surgically removed: the drug doxorubicin alone, versus doxorubicin combined with a newer drug called lurbinectedin. Researchers want to see if the combination works better as a first treatment. **You may be eligible if...** - You are 18 or older - You have been diagnosed with metastatic leiomyosarcoma confirmed by biopsy - You have not received prior chemotherapy for metastatic disease, and have never received an anthracycline drug (like doxorubicin) - You have at least one measurable tumor on imaging - You are in good physical condition (ECOG 0–1) **You may NOT be eligible if...** - You have had prior chemotherapy with an anthracycline - You have significant heart disease - You have poor liver or kidney function - You are pregnant or breastfeeding - You have brain metastases that are not stable Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGLurbinectedin

IV Infusion

DRUGDoxorubicin

Short IV push or bolus (according to label)

Locations(97)

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

Massachusetts General Hospital

Boston, Massachusetts, United States

Dana-Farber Cancer Institute

Boston, Massachusetts, United States

University of Michigan

Ann Arbor, Michigan, United States

Mayo Clinic - Rochester

Rochester, Minnesota, United States

Washington University School of Medicine in St. Louis

St Louis, Missouri, United States

Memorial Sloan Kettering Cancer Center - New York

New York, New York, United States

Cleveland Clinic Main Campus

Cleveland, Ohio, United States

Oregon Health and Science University

Portland, Oregon, United States

University of Pennsylvania Abramson Cancer Center

Philadelphia, Pennsylvania, United States

University of Pittsburgh Medical Center (UPMC) Hillman Cancer Center

Pittsburgh, Pennsylvania, United States

Vanderbilt - Ingram Cancer Center

Nashville, Tennessee, United States

UT Southwestern Harold C. Simmons Comprehensive Cancer Center

Dallas, Texas, United States

University of Texas MD Anderson Cancer Center

Houston, Texas, United States

Fred Hutchinson Cancer Center - Seattle Cancer Care Alliance (SCCA) Location

Seattle, Washington, United States

Universitaetsklinikum Graz - Universitätsklinik für Innere Medizin

Graz, Austria

Medizinische Universität Innsbruck

Innsbruck, Austria

Ordensklinikum Linz GmbH Barmherzige Schwestern

Linz, Austria

Medizinische Universität Wien

Vienna, Austria

Universitair Ziekenhuis Bruseel

Jette, Brussels Capital, Belgium

Institut Jules Bordet

Anderlecht, Belgium

Cliniques Universitaires Saint-Luc

Brussels, Belgium

Universitair Ziekenhuis Leuven - Campus Gasthuisberg

Leuven, Belgium

Centre Léon Bérard

Lyon, Auvergne-Rhône-Alpes, France

Centre Hospitalier Régional et Universitaire de Besançon - Hôpital Jean-Minjoz

Besançon, Doubs, France

Institut de Cancérologie de l'Ouest - Angers

Angers, Pays de la Loire Region, France

Centre Antoine Lacassagne

Nice, Provence-Alpes-Côte d'Azur Region, France

Institut Bergonié

Bordeaux, France

Centre de Lutte contre le Cancer - Centre Oscar Lambret

Lille, France

Centre Hospitalier Universitaire Dupuytren 1

Limoges, France

Hôspital de la Timone

Marseille, France

Institut Curie

Paris, France

Centre Hospitalier Universitaire de Poitiers

Poitiers, France

Centre Eugène Marquis

Rennes, France

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

Saint-Herblain, France

Gustave Roussy

Villejuif, France

LMU Klinikum - Campus Großhadern

München, Bavaria, Germany

Helios Klinikum Bad Saarow

Bad Saarow, Germany

Universitatsklinikum Carl Gustav Carus Dresden

Dresden, Germany

Medizinische Hochschule Hannover

Hanover, Germany

Universitätsklinikum Heidelberg

Heidelberg, Germany

Universitätsmedizin Mannheim

Manheim, Germany

Universitätsklinikum Münster

Münster, Germany

Universitätsklinikum Tübingen

Tübingen, Germany

Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) - Istituto Clinico Humanitas

Rozzano, Milan, Italy

Istituto Nazionale Tumori IRCCS Fondazione G. Pascale

Naples, Naples, Italy

Centro di Riferimento Oncologico

Aviano, Italy

Istituto Ortopedico Rizzoli

Bologna, Italy

Azienda Ospedaliero-Universitaria di Bologna - Policlinico Sant Orsola-Malpighi

Bologna, Italy

Istituto di Candiolo - Fondazione del Piemonte per l'Oncologia

Candiolo, Italy

Azienda Ospedaliero - Universitaria San Luigi Gonzaga

Orbassano, Italy

Istituto Oncologico Veneto - IRCCS

Padova, Italy

Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone

Palermo, Italy

Università Campus Bio-Medico di Roma

Roma, Italy

Istituto Nazionale Tumori Regina Elena

Roma, Italy

Azienda Ospedaliero-Universitaria Citta della Salute e della Scienza di Torino

Torino, Italy

Het Nederlands Kanker Instituut

Amsterdam, North Holland, Netherlands

Leids Universitair Medisch Centrum (LUMC)

Leiden, South Holland, Netherlands

Narodowy Instytut Onkologii im. Marii Skłodowskiej-Curie - Państwowy Instytut Badawczy

Warsaw, Masovian Voivodeship, Poland

Szpitale Pomorskie Spółka Z Ograniczoną Odpowiedzialnością

Gdynia, Pomeranian Voivodeship, Poland

Instituto Portugues De Oncologia De Lisboa Francisco Gentil

Lisbon, Lisbon District, Portugal

Unidade Local de Saúde de Coimbra

Coimbra, Portugal

Unidade Local de Saúde de Santo António, E.P.E - Hospital Geral de Santo António

Porto, Portugal

Instituto Português de Oncologia do Porto Francisco Gentil

Porto, Portugal

Complejo Hospitalario Universitario A Coruña

A Coruña, Spain

Complejo Hospitalario Universitario de Santiago (CHUS)

A Coruña, Spain

Hospital de la Santa Creu i Sant Pau

Barcelona, Spain

Hospital Universitari Vall d'Hebrón

Barcelona, Spain

Institut Català d'Oncologia - Hospital Duran i Reynals (ICO L'Hospitalet)

Barcelona, Spain

Hospital General Universitario Gregorio Marañón

Madrid, Spain

Hospital Clínico San Carlos

Madrid, Spain

Hospital Universitario Fundación Jiménez Díaz

Madrid, Spain

Hospital Universitario La Paz

Madrid, Spain

START Madrid - CIOCC - HM Sanchinarro

Madrid, Spain

Hospital Universitario de Canarias

San Cristóbal de La Laguna, Spain

Hospital Universitario Virgen del Rocío

Seville, Spain

Hospital Clínico Universitario de Valencia

Valencia, Spain

Hospital Universitari i Politècnic La Fe

Valencia, Spain

Hospital Universitario Miguel Servet

Zaragoza, Spain

Universitätsspital Basel

Basel, Switzerland

Centre Hospitalier Universitaire Vaudois Lausanne

Lausanne, Switzerland

University Hospital Birmingham NHS Foundation Trust

Birmingham, United Kingdom

Cambridge University Hospitals NHS Foundation Trust

Cambridge, United Kingdom

The Clatterbridge Cancer Centre NHS Foundation Trust

Liverpool, United Kingdom

University College London Hospitals NHS Foundation Trust

London, United Kingdom

The Royal Marsden NHS Foundation Trust

London, United Kingdom

The Christie NHS Foundation Trust

Manchester, United Kingdom

Oxford University Hospitals NHS Foundation Trust

Oxford, United Kingdom

View Full Details on ClinicalTrials.gov

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NCT06088290

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