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RECRUITING

NCT06088290

PHASE3

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

Sponsor: 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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

450

Start Date

2023-09-21

Completion Date

2029-08-30

Last Updated

2026-03-11

Healthy Volunteers

Conditions

Leiomyosarcoma

Interventions

DRUG

Lurbinectedin

IV Infusion

DRUG

Doxorubicin

Short IV push or bolus (according to label)

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). 3. Total bilirubin ≤ 1.5 x ULN or direct bilirubin ≤ ULN if total bilirubin is \> ULN. 4. Albumin ≥ 3.0 g/dL. 5. Calculated creatinine clearance (CrCL) ≥ 30 mL/min (using Cockcroft and Gault's formula). 6. Left ventricular ejection fraction (LVEF) \> 50% assessed by multiple-gated acquisition scan (MUGA) or echocardiography (ECHO) or cardiac magnetic resonance imaging (MRI). 8. Wash-out periods: 1. At least three weeks since last prior systemic treatment. 2. 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). 3. At least two weeks since last prior radiotherapy. 9. Evidence of non-childbearing status for women of childbearing potential (WOCBP). WOCBP must agree to use a highly effective contraceptive measure up to seven months after treatment discontinuation. Fertile male participants with WOCBP partners should use condoms during treatment and for four months following the last investigational medicinal product (IMP) dose. 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. Prior irradiation of a RECIST v.1.1 target lesion if only one target lesion is available, unless progression of the lesion has been confirmed. 7. Known myopathy (history of resolved steroid-induced myopathy is allowed). 8. History of malignancies other than LMS within three years prior to enrollment, except for malignancies with a negligible risk of metastasis or death (e.g., 5-year OS rate \>90%), such as adequately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, localized prostate cancer, non-muscle-invasive urothelial carcinomas, ductal carcinoma in situ, or stage I uterine cancer. Prior malignancies should have received curative treatment and should remain in remission. The Investigator should ensure, based on histology or clinical information, that the current metastatic sites are leiomyosarcoma and not recurrence of the original malignancy. 9. Limitation of the participant's ability to comply with the treatment or to follow-up the protocol. 10. Women who are pregnant or breast feeding and fertile participants (men and women) who are not using a highly effective method of contraception. 11. Participants in whom rapid tumor shrinkage is needed (e.g., when a tumor is close to a critical structure).

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

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

Vanderbilt - Ingram Cancer Center

Nashville, Tennessee, 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

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

Clinical Research Directory

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

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (94)