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

NCT06088290 | Recruiting Phase 3 DMC FDA Drug

• 2 other identifiers: PM1183-C-010-222022-502975-45
• Study Type: interventional
• Target: 450
• Locations: 12 countries
• Sites: 97

Brief 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

Leiomyosarcoma

Keywords

Leiomyosarcoma; Oncology

Outcome Measures

Primary Outcomes (1)

• PFS by IRC

  Up to approximately 41 months

Secondary Outcomes (13)

• Overall Survival (OS)

  Up to approximately 66 months

• PFS by Investigator's Assessment (IA)

  Up to approximately 41 months

• Overall Response Rate (ORR) by IRC and IA

  Up to approximately 66 months

• Duration of Response (DoR) by IRC and IA

  Up to approximately 66 months

• Clinical Benefit Rate (CBR) by IRC and IA

  Up to approximately 66 months

Study Arms (3)

Doxorubicin (Dose A) + Lurbinectedin (Dose B)

EXPERIMENTAL

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

Drug: Lurbinectedin; Drug: Doxorubicin

Doxorubicin (Dose C) + Lurbinectedin (Dose D)

EXPERIMENTAL

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

Drug: Lurbinectedin; Drug: Doxorubicin

Doxorubicin

ACTIVE COMPARATOR

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

Drug: Doxorubicin

Interventions

Lurbinectedin DRUG

IV Infusion

Doxorubicin (Dose A) + Lurbinectedin (Dose B); Doxorubicin (Dose C) + Lurbinectedin (Dose D)

Doxorubicin DRUG

Short IV push or bolus (according to label)

Doxorubicin; Doxorubicin (Dose A) + Lurbinectedin (Dose B); Doxorubicin (Dose C) + Lurbinectedin (Dose D)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Radiologically measurable disease according to the Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1.
• 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.
• Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤ 1.
• Adequate hematological, renal, metabolic and hepatic function:
• 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.
• Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3.0 x upper limit of normal (ULN).
• Total bilirubin ≤ 1.5 x ULN or direct bilirubin ≤ ULN if total bilirubin is \> ULN.
• Albumin ≥ 3.0 g/dL.
• Calculated creatinine clearance (CrCL) ≥ 30 mL/min (using Cockcroft and Gault's formula).
• Left ventricular ejection fraction (LVEF) \> 50% assessed by multiple-gated acquisition scan (MUGA) or echocardiography (ECHO) or cardiac magnetic resonance imaging (MRI).
• Wash-out periods:

You may not qualify if:

• 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.
• Concomitant diseases/conditions:
• History of cardiac disease: myocardial infarction or angina within the year prior to enrollment; severe vascular disease; or symptomatic arrhythmia despite ongoing treatment.
• Participants with any immunodeficiency, including those known to be infected by human immunodeficiency virus (HIV).
• 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.
• Active uncontrolled infection.
• 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.
• Use of strong inducers of CYP3A4 activity within two weeks prior to the first infusion of lurbinectedin.
• 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.
• Known myopathy (history of resolved steroid-induced myopathy is allowed).
• 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.
• Limitation of the participant's ability to comply with the treatment or to follow-up the protocol.
• Women who are pregnant or breast feeding and fertile participants (men and women) who are not using a highly effective method of contraception.

Sponsors & Collaborators

• PharmaMar: lead

Study Sites (97)

Mayo Clinic Hospital - Phoenix

Phoenix, Arizona, 85054, United States

RECRUITING

Precision NextGen Oncology & Research Center

Beverly Hills, California, 90212, United States

RECRUITING

Cedars-Sinai Medical Center

Los Angeles, California, 90025, United States

NOT YET RECRUITING

Norris Comprehensive Cancer Center

Los Angeles, California, 90033, United States

RECRUITING

Sarcoma Oncology Center

Los Angeles, California, 90057, United States

RECRUITING

Stanford University (Leland Stanford Junior University)

Palo Alto, California, 94304, United States

RECRUITING

University of Colorado Hospital - Anschutz Medical Campus

Aurora, Colorado, 80045, United States

RECRUITING

Mayo Clinic - Jacksonville

Jacksonville, Florida, 32224, United States

RECRUITING

Moffitt Cancer Center

Tampa, Florida, 33612, United States

RECRUITING

Augusta University Georgia Cancer Center

Augusta, Georgia, 30912, United States

RECRUITING

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

RECRUITING

Dana-Farber Cancer Institute

Boston, Massachusetts, 02215, United States

RECRUITING

University of Michigan

Ann Arbor, Michigan, 48109, United States

RECRUITING

Mayo Clinic - Rochester

Rochester, Minnesota, 55905, United States

RECRUITING

Washington University School of Medicine in St. Louis

St Louis, Missouri, 63110, United States

RECRUITING

Memorial Sloan Kettering Cancer Center - New York

New York, New York, 10065, United States

RECRUITING

Cleveland Clinic Main Campus

Cleveland, Ohio, 44195, United States

COMPLETED

Oregon Health and Science University

Portland, Oregon, 97239, United States

RECRUITING

University of Pennsylvania Abramson Cancer Center

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

University of Pittsburgh Medical Center (UPMC) Hillman Cancer Center

Pittsburgh, Pennsylvania, 15232, United States

RECRUITING

Vanderbilt - Ingram Cancer Center

Nashville, Tennessee, 37232, United States

RECRUITING

UT Southwestern Harold C. Simmons Comprehensive Cancer Center

Dallas, Texas, 75390-8562, United States

RECRUITING

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

RECRUITING

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

Seattle, Washington, 98109, United States

RECRUITING

Universitaetsklinikum Graz - Universitätsklinik für Innere Medizin

Graz, 8036, Austria

RECRUITING

Medizinische Universität Innsbruck

Innsbruck, 6020, Austria

RECRUITING

Ordensklinikum Linz GmbH Barmherzige Schwestern

Linz, 4010, Austria

NOT YET RECRUITING

Medizinische Universität Wien

Vienna, 1090, Austria

RECRUITING

Universitair Ziekenhuis Bruseel

Jette, Brussels Capital, 1090, Belgium

RECRUITING

Institut Jules Bordet

Anderlecht, 1070, Belgium

RECRUITING

Cliniques Universitaires Saint-Luc

Brussels, 1200, Belgium

RECRUITING

Universitair Ziekenhuis Leuven - Campus Gasthuisberg

Leuven, 3000, Belgium

RECRUITING

Centre Léon Bérard

Lyon, Auvergne-Rhône-Alpes, 69008, France

RECRUITING

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

Besançon, Doubs, 25030, France

RECRUITING

Institut de Cancérologie de l'Ouest - Angers

Angers, Pays de la Loire Region, 49055, France

RECRUITING

Centre Antoine Lacassagne

Nice, Provence-Alpes-Côte d'Azur Region, 06189, France

RECRUITING

Institut Bergonié

Bordeaux, 33076, France

RECRUITING

Centre de Lutte contre le Cancer - Centre Oscar Lambret

Lille, 59000, France

ACTIVE NOT RECRUITING

Centre Hospitalier Universitaire Dupuytren 1

Limoges, 87042, France

RECRUITING

Hôspital de la Timone

Marseille, 13005, France

COMPLETED

Institut Curie

Paris, 75005, France

RECRUITING

Centre Hospitalier Universitaire de Poitiers

Poitiers, 86000, France

RECRUITING

Centre Eugène Marquis

Rennes, 35042, France

RECRUITING

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

Saint-Herblain, 44805, France

RECRUITING

Gustave Roussy

Villejuif, 94805, France

RECRUITING

LMU Klinikum - Campus Großhadern

München, Bavaria, 81675, Germany

RECRUITING

Helios Klinikum Bad Saarow

Bad Saarow, 15526, Germany

RECRUITING

Universitatsklinikum Carl Gustav Carus Dresden

Dresden, 01307, Germany

RECRUITING

Medizinische Hochschule Hannover

Hanover, 30625, Germany

RECRUITING

Universitätsklinikum Heidelberg

Heidelberg, 69120, Germany

ACTIVE NOT RECRUITING

Universitätsmedizin Mannheim

Manheim, 68167, Germany

RECRUITING

Universitätsklinikum Münster

Münster, 48149, Germany

RECRUITING

Universitätsklinikum Tübingen

Tübingen, 72016, Germany

RECRUITING

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

Rozzano, Milan, 20089, Italy

RECRUITING

Istituto Nazionale Tumori IRCCS Fondazione G. Pascale

Naples, Naples, 80131, Italy

RECRUITING

Centro di Riferimento Oncologico

Aviano, 33081, Italy

RECRUITING

Istituto Ortopedico Rizzoli

Bologna, 40136, Italy

RECRUITING

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

Bologna, Italy

RECRUITING

Istituto di Candiolo - Fondazione del Piemonte per l'Oncologia

Candiolo, 10060, Italy

RECRUITING

Azienda Ospedaliero - Universitaria San Luigi Gonzaga

Orbassano, 10043, Italy

RECRUITING

Istituto Oncologico Veneto - IRCCS

Padova, 35128, Italy

RECRUITING

Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone

Palermo, 90127, Italy

RECRUITING

Università Campus Bio-Medico di Roma

Roma, 00128, Italy

RECRUITING

Istituto Nazionale Tumori Regina Elena

Roma, 00144, Italy

RECRUITING

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

Torino, 10126, Italy

COMPLETED

Het Nederlands Kanker Instituut

Amsterdam, North Holland, 1066 CX, Netherlands

RECRUITING

Leids Universitair Medisch Centrum (LUMC)

Leiden, South Holland, 2333 ZA, Netherlands

RECRUITING

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

Warsaw, Masovian Voivodeship, 02-781, Poland

RECRUITING

Szpitale Pomorskie Spółka Z Ograniczoną Odpowiedzialnością

Gdynia, Pomeranian Voivodeship, 81-519, Poland

RECRUITING

Instituto Portugues De Oncologia De Lisboa Francisco Gentil

Lisbon, Lisbon District, 1099-023, Portugal

RECRUITING

Unidade Local de Saúde de Coimbra

Coimbra, 3000-075, Portugal

NOT YET RECRUITING

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

Porto, 4050-342, Portugal

RECRUITING

Instituto Português de Oncologia do Porto Francisco Gentil

Porto, 4200-072, Portugal

RECRUITING

Complejo Hospitalario Universitario A Coruña

A Coruña, 15006, Spain

RECRUITING

Complejo Hospitalario Universitario de Santiago (CHUS)

A Coruña, 15006, Spain

RECRUITING

Hospital de la Santa Creu i Sant Pau

Barcelona, 08025, Spain

RECRUITING

Hospital Universitari Vall d'Hebrón

Barcelona, 08035, Spain

RECRUITING

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

Barcelona, 08908, Spain

RECRUITING

Hospital General Universitario Gregorio Marañón

Madrid, 28007, Spain

RECRUITING

Hospital Clínico San Carlos

Madrid, 28040, Spain

RECRUITING

Hospital Universitario Fundación Jiménez Díaz

Madrid, 28040, Spain

RECRUITING

Hospital Universitario La Paz

Madrid, 28046, Spain

COMPLETED

START Madrid - CIOCC - HM Sanchinarro

Madrid, 28050, Spain

RECRUITING

Hospital Universitario de Canarias

San Cristóbal de La Laguna, 38320, Spain

NOT YET RECRUITING

Hospital Universitario Virgen del Rocío

Seville, 41013, Spain

RECRUITING

Hospital Clínico Universitario de Valencia

Valencia, 46010, Spain

RECRUITING

Hospital Universitari i Politècnic La Fe

Valencia, 46026, Spain

RECRUITING

Hospital Universitario Miguel Servet

Zaragoza, 50009, Spain

RECRUITING

Universitätsspital Basel

Basel, 4031, Switzerland

COMPLETED

Centre Hospitalier Universitaire Vaudois Lausanne

Lausanne, 1011, Switzerland

RECRUITING

University Hospital Birmingham NHS Foundation Trust

Birmingham, B15 2GW, United Kingdom

RECRUITING

Cambridge University Hospitals NHS Foundation Trust

Cambridge, CB2 0QQ, United Kingdom

NOT YET RECRUITING

The Clatterbridge Cancer Centre NHS Foundation Trust

Liverpool, L7 8YA, United Kingdom

RECRUITING

University College London Hospitals NHS Foundation Trust

London, NW1 2BU, United Kingdom

RECRUITING

The Royal Marsden NHS Foundation Trust

London, SW3 6JJ, United Kingdom

RECRUITING

The Christie NHS Foundation Trust

Manchester, M20 4BX, United Kingdom

RECRUITING

Oxford University Hospitals NHS Foundation Trust

Oxford, OX3 7LE, United Kingdom

RECRUITING

Related Publications (1)

• Cote GM, Chawla SP, Demetri G, Kasper B, Jones RL, Broto JM, Wooley J, Weiss MC, Tafuto S, Badalamenti G, Carrasco I, Peinado P, Blay JY, Boggio G, Fernandez C, Nieto A, Kahatt C, Alfaro V, Le Cesne A. SaLudo: a randomized phase IIb/III study of lurbinectedin plus doxorubicin as first-line treatment in leiomyosarcoma. Future Oncol. 2025 Apr;21(8):943-951. doi: 10.1080/14796694.2025.2463798. Epub 2025 Feb 11.

  PMID: 39932221 DERIVED

MeSH Terms

Conditions

Leiomyosarcoma; Neoplasms

Interventions

PM 01183; Doxorubicin

Condition Hierarchy (Ancestors)

Neoplasms, Muscle Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Sarcoma

Intervention Hierarchy (Ancestors)

Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates

Central Study Contacts

Gaston Federico Boggio, M.D.

CONTACT

+34 91 823 4524; gfboggio@pharmamar.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 28, 2023
• First Posted: October 18, 2023
• Study Start: September 21, 2023
• Primary Completion (Estimated): August 30, 2029
• Study Completion (Estimated): August 30, 2029
• Last Updated: April 17, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

GB (7); US (24); IT (12); NL (2); PT (4); AU (4); ES (15); BE (4); DE (8); PL (2); FR (13); CH (2)