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LeiomyosarcomaPhase 3SaLuDoNCT06088290

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

A Phase 3 study testing Lurbinectedin and Doxorubicin in people with Leiomyosarcoma, run by PharmaMar at 97 sites in 12 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

The primary objective of this phase III trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Leiomyosarcoma
What is being tested?
Lurbinectedin and Doxorubicin
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
469 participants
Where
97 sitesin 12 countries
Study dates
21 Sep 2023to 30 Aug 2029
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Voluntary signed and dated written informed consent of the participants obtained before any trial-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.
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  • 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:
  • 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.
  • 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.

Who cannot join

  • 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).
Show all 16Show fewer
  • 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 trial.
  • 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.
  • Participants in whom rapid tumor shrinkage is needed (e.g., when a tumor is close to a critical structure).

Trial locations and contacts

97 sites in 12 countries.

97 sites in 12 countries

United States24 sites

  • University of Michigan

    Ann Arbor, Michigan, 48109

  • Augusta University Georgia Cancer Center

    Augusta, Georgia, 30912

  • University of Colorado Hospital - Anschutz Medical Campus

    Aurora, Colorado, 80045

  • Precision NextGen Oncology & Research Center

    Beverly Hills, California, 90212

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

  • Dana-Farber Cancer Institute

    Boston, Massachusetts, 02215

  • Cleveland Clinic Main Campus

    Cleveland, Ohio, 44195

  • UT Southwestern Harold C. Simmons Comprehensive Cancer Center

    Dallas, Texas, 75390-8562

  • University of Texas MD Anderson Cancer Center

    Houston, Texas, 77030

  • Mayo Clinic - Jacksonville

    Jacksonville, Florida, 32224

  • Cedars-Sinai Medical Center

    Los Angeles, California, 90025

  • Norris Comprehensive Cancer Center

    Los Angeles, California, 90033

  • Sarcoma Oncology Center

    Los Angeles, California, 90057

  • Vanderbilt - Ingram Cancer Center

    Nashville, Tennessee, 37232

  • Memorial Sloan Kettering Cancer Center - New York

    New York, New York, 10065

  • Stanford University (Leland Stanford Junior University)

    Palo Alto, California, 94304

  • University of Pennsylvania Abramson Cancer Center

    Philadelphia, Pennsylvania, 19104

  • Mayo Clinic Hospital - Phoenix

    Phoenix, Arizona, 85054

  • University of Pittsburgh Medical Center (UPMC) Hillman Cancer Center

    Pittsburgh, Pennsylvania, 15232

  • Oregon Health and Science University

    Portland, Oregon, 97239

  • Mayo Clinic - Rochester

    Rochester, Minnesota, 55905

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

    Seattle, Washington, 98109

  • Washington University School of Medicine in St. Louis

    St Louis, Missouri, 63110

  • Moffitt Cancer Center

    Tampa, Florida, 33612

Other trials in United States

Spain15 sites

  • Complejo Hospitalario Universitario A Coruña

    A Coruña, 15006

  • Complejo Hospitalario Universitario de Santiago (CHUS)

    A Coruña, 15006

  • Hospital de la Santa Creu i Sant Pau

    Barcelona, 08025

  • Hospital Universitari Vall d'Hebrón

    Barcelona, 08035

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

    Barcelona, 08908

  • Hospital General Universitario Gregorio Marañón

    Madrid, 28007

  • Hospital Clínico San Carlos

    Madrid, 28040

  • Hospital Universitario Fundación Jiménez Díaz

    Madrid, 28040

  • Hospital Universitario La Paz

    Madrid, 28046

  • START Madrid - CIOCC - HM Sanchinarro

    Madrid, 28050

  • Hospital Universitario de Canarias

    San Cristóbal de La Laguna, 38320

  • Hospital Universitario Virgen del Rocío

    Seville, 41013

  • Hospital Clínico Universitario de Valencia

    Valencia, 46010

  • Hospital Universitari i Politècnic La Fe

    Valencia, 46026

  • Hospital Universitario Miguel Servet

    Zaragoza, 50009

Other trials in Spain

France13 sites

  • Institut de Cancérologie de l'Ouest - Angers

    Angers, Pays de la Loire Region, 49055

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

    Besançon, Doubs, 25030

  • Institut Bergonié

    Bordeaux, 33076

  • Centre de Lutte contre le Cancer - Centre Oscar Lambret

    Lille, 59000

  • Centre Hospitalier Universitaire Dupuytren 1

    Limoges, 87042

  • Centre Léon Bérard

    Lyon, Auvergne-Rhône-Alpes, 69008

  • Hôspital de la Timone

    Marseille, 13005

  • Centre Antoine Lacassagne

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

  • Institut Curie

    Paris, 75005

  • Centre Hospitalier Universitaire de Poitiers

    Poitiers, 86000

  • Centre Eugène Marquis

    Rennes, 35042

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

    Saint-Herblain, 44805

  • Gustave Roussy

    Villejuif, 94805

Other trials in France

Italy12 sites

  • Centro di Riferimento Oncologico

    Aviano, 33081

  • Istituto Ortopedico Rizzoli

    Bologna, 40136

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

    Bologna

  • Istituto di Candiolo - Fondazione del Piemonte per l'Oncologia

    Candiolo, 10060

  • Istituto Nazionale Tumori IRCCS Fondazione G. Pascale

    Naples, Naples, 80131

  • Azienda Ospedaliero - Universitaria San Luigi Gonzaga

    Orbassano, 10043

  • Istituto Oncologico Veneto - IRCCS

    Padova, 35128

  • Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone

    Palermo, 90127

  • Università Campus Bio-Medico di Roma

    Roma, 00128

  • Istituto Nazionale Tumori Regina Elena

    Roma, 00144

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

    Rozzano, Milan, 20089

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

    Torino, 10126

Other trials in Italy

Germany8 sites

  • Helios Klinikum Bad Saarow

    Bad Saarow, 15526

  • Universitatsklinikum Carl Gustav Carus Dresden

    Dresden, 01307

  • Medizinische Hochschule Hannover

    Hanover, 30625

  • Universitätsklinikum Heidelberg

    Heidelberg, 69120

  • Universitätsmedizin Mannheim

    Manheim, 68167

  • LMU Klinikum - Campus Großhadern

    München, Bavaria, 81675

  • Universitätsklinikum Münster

    Münster, 48149

  • Universitätsklinikum Tübingen

    Tübingen, 72016

Other trials in Germany

United Kingdom7 sites

  • University Hospital Birmingham NHS Foundation Trust

    Birmingham, B15 2GW

  • Cambridge University Hospitals NHS Foundation Trust

    Cambridge, CB2 0QQ

  • The Clatterbridge Cancer Centre NHS Foundation Trust

    Liverpool, L7 8YA

  • University College London Hospitals NHS Foundation Trust

    London, NW1 2BU

  • The Royal Marsden NHS Foundation Trust

    London, SW3 6JJ

  • The Christie NHS Foundation Trust

    Manchester, M20 4BX

  • Oxford University Hospitals NHS Foundation Trust

    Oxford, OX3 7LE

Other trials in United Kingdom

Austria4 sites

  • Universitaetsklinikum Graz - Universitätsklinik für Innere Medizin

    Graz, 8036

  • Medizinische Universität Innsbruck

    Innsbruck, 6020

  • Ordensklinikum Linz GmbH Barmherzige Schwestern

    Linz, 4010

  • Medizinische Universität Wien

    Vienna, 1090

Other trials in Austria

Belgium4 sites

  • Institut Jules Bordet

    Anderlecht, 1070

  • Cliniques Universitaires Saint-Luc

    Brussels, 1200

  • Universitair Ziekenhuis Bruseel

    Jette, Brussels Capital, 1090

  • Universitair Ziekenhuis Leuven - Campus Gasthuisberg

    Leuven, 3000

Other trials in Belgium

Portugal4 sites

  • Unidade Local de Saúde de Coimbra

    Coimbra, 3000-075

  • Instituto Portugues De Oncologia De Lisboa Francisco Gentil

    Lisbon, Lisbon District, 1099-023

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

    Porto, 4050-342

  • Instituto Português de Oncologia do Porto Francisco Gentil

    Porto, 4200-072

Other trials in Portugal

Netherlands2 sites

  • Het Nederlands Kanker Instituut

    Amsterdam, North Holland, 1066 CX

  • Leids Universitair Medisch Centrum (LUMC)

    Leiden, South Holland, 2333 ZA

Other trials in Netherlands

Poland2 sites

  • Szpitale Pomorskie Spółka Z Ograniczoną Odpowiedzialnością

    Gdynia, Pomeranian Voivodeship, 81-519

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

    Warsaw, Masovian Voivodeship, 02-781

Other trials in Poland

Switzerland2 sites

  • Universitätsspital Basel

    Basel, 4031

  • Centre Hospitalier Universitaire Vaudois Lausanne

    Lausanne, 1011

Other trials in Switzerland

About this study

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

The primary objective of this phase III trial 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
Being tested
Lurbinectedin, Doxorubicin
Keywords
Leiomyosarcoma, Oncology
Medical subject headings
Leiomyosarcoma, Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LurbinectedinDrug

    IV Infusion

  • DoxorubicinDrug

    Short IV push or bolus (according to label)

Study groups in NCT06088290
Study groupRoleWhat they receive
Doxorubicin (Dose A) + Lurbinectedin (Dose B)ExperimentalParticipants will receive doxorubicin and lurbinectedin intravenously (IV) every three weeks (q3wk) on Day 1 of each treatment cycle (treatment cycle = three weeks).
Receives: Drug: Lurbinectedin; Drug: Doxorubicin
Doxorubicin (Dose C) + Lurbinectedin (Dose D)ExperimentalParticipants will receive doxorubicin and lurbinectedin IV q3wk on Day 1 of each treatment cycle (treatment cycle = three weeks).
Receives: Drug: Lurbinectedin; Drug: Doxorubicin
Doxorubicin (Dose E)Active comparatorParticipants will receive doxorubicin IV q3wk on Day 1 of each treatment cycle (treatment cycle = three weeks).
Receives: Drug: Doxorubicin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. PFS by IRC

    Measured: Up to approximately 41 months

Secondary outcomes (13)

  1. Overall Survival (OS)

    Measured: Up to approximately 66 months

  2. PFS by Investigator's Assessment (IA)

    Measured: Up to approximately 41 months

  3. Overall Response Rate (ORR) by IRC and IA

    Measured: Up to approximately 66 months

  4. Duration of Response (DoR) by IRC and IA

    Measured: Up to approximately 66 months

  5. Clinical Benefit Rate (CBR) by IRC and IA

    Measured: Up to approximately 66 months

  6. PFS on Next-line Therapy (PFS2) by IA

    Measured: Up to approximately 41 months

  7. Number of Participants Experiencing Adverse Events (AEs)

    Measured: Up to approximately 66 months

  8. Number of Participants Experiencing Serious Adverse Events (SAEs)

    Measured: Up to approximately 66 months

  9. Change in Quality of Life by European Organization for Research and Treatment of Cancer (EORTC) 30-item Quality of Life Questionnaire (QLQ-C30)

    Measured: Up to approximately 41 months

  10. Clearance of Lurbinectedin and Doxorubicin in the Plasma

    Measured: Cycle 1 Day 1, and Day 5 (One cycle = 3 weeks)

  11. Volume of Distribution of Lurbinectedin and Doxorubicin in the Plasma

    Measured: Cycle 1 Day 1, and Day 5 (One cycle = 3 weeks)

  12. Number of Participants With Presence or Absence of Mutation per Molecular Biomarker Associated With Response and/or Resistance to Treatment

    Measured: Up to approximately 41 months

  13. Expression Levels of Molecular Biomarkers Associated with Response and/or Resistance to Treatment

    Measured: Up to approximately 41 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Oct 2023
  2. Study start21 Sep 2023
  3. Primary completion30 Aug 2029 (estimated)
  4. Study completion30 Aug 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
469 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06088290
Sponsor's protocol ID
PM1183-C-010-22
Other IDs
2022-502975-45
Acronym
SaLuDo
Status last verified
Jun 2026
First submitted
28 Sep 2023
Last updated
18 Jun 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 39932221

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Lurbinectedin and Doxorubicin in people with Leiomyosarcoma, run by PharmaMar at 97 sites in 12 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 19 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 18 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 97 sites in United States, Spain, France, Italy, Germany and 7 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

PFS by IRC (time frame: Up to approximately 41 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06088290, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2026.

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