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New hope for leiomyosarcoma: drug combo trial aims to slow tumor growth

NCT ID NCT06088290

Disease control Sponsor: PharmaMar Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This phase 3 trial tests whether adding lurbinectedin to standard doxorubicin chemotherapy helps people with metastatic leiomyosarcoma live longer without their cancer growing. About 469 adults who have not had prior treatment for advanced disease are being studied. The main goal is to see if the combination delays tumor progression compared to doxorubicin alone.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
lurbinectedin and doxorubicin
What this could lead to
If successful, this combination could become a new first-line treatment option for people with metastatic leiomyosarcoma, potentially slowing tumor growth better than current standard therapy.
What could go wrong
This is a phase 3 trial, but results are not yet available. The combination may not improve survival or could cause more side effects than doxorubicin alone. Success is not guaranteed.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

469 people

The number who actually took part.

Started

Sep 2023

Expected to finish

Aug 2029

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Voluntary signed and dated written informed consent of the participants obtained before any trial-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 trial. 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).

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Conditions

The condition(s) this trial relates to.

leiomyosarcoma neoplasm

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Leiomyosarcoma

Contacts and locations

Locations

  • Augusta University Georgia Cancer Center

    Augusta, Georgia, 30912, United States

  • Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone

    Palermo, 90127, Italy

  • Azienda Ospedaliero - Universitaria San Luigi Gonzaga

    Orbassano, 10043, Italy

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

    Torino, 10126, Italy

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

    Bologna, Italy

  • Cambridge University Hospitals NHS Foundation Trust

    Cambridge, CB2 0QQ, United Kingdom

  • Cedars-Sinai Medical Center

    Los Angeles, California, 90025, United States

  • Centre Antoine Lacassagne

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

  • Centre Eugène Marquis

    Rennes, 35042, France

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

    Besançon, Doubs, 25030, France

  • Centre Hospitalier Universitaire Dupuytren 1

    Limoges, 87042, France

  • Centre Hospitalier Universitaire Vaudois Lausanne

    Lausanne, 1011, Switzerland

  • Centre Hospitalier Universitaire de Poitiers

    Poitiers, 86000, France

  • Centre Léon Bérard

    Lyon, Auvergne-Rhône-Alpes, 69008, France

  • Centre de Lutte contre le Cancer - Centre Oscar Lambret

    Lille, 59000, France

  • Centro di Riferimento Oncologico

    Aviano, 33081, Italy

  • Cleveland Clinic Main Campus

    Cleveland, Ohio, 44195, United States

  • Cliniques Universitaires Saint-Luc

    Brussels, 1200, Belgium

  • Complejo Hospitalario Universitario A Coruña

    A Coruña, 15006, Spain

  • Complejo Hospitalario Universitario de Santiago (CHUS)

    A Coruña, 15006, Spain

  • Dana-Farber Cancer Institute

    Boston, Massachusetts, 02215, United States

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

    Seattle, Washington, 98109, United States

  • Gustave Roussy

    Villejuif, 94805, France

  • Helios Klinikum Bad Saarow

    Bad Saarow, 15526, Germany

  • Het Nederlands Kanker Instituut

    Amsterdam, North Holland, 1066 CX, Netherlands

  • Hospital Clínico San Carlos

    Madrid, 28040, Spain

  • Hospital Clínico Universitario de Valencia

    Valencia, 46010, Spain

  • Hospital General Universitario Gregorio Marañón

    Madrid, 28007, Spain

  • Hospital Universitari Vall d'Hebrón

    Barcelona, 08035, Spain

  • Hospital Universitari i Politècnic La Fe

    Valencia, 46026, Spain

  • Hospital Universitario Fundación Jiménez Díaz

    Madrid, 28040, Spain

  • Hospital Universitario La Paz

    Madrid, 28046, Spain

  • Hospital Universitario Miguel Servet

    Zaragoza, 50009, Spain

  • Hospital Universitario Virgen del Rocío

    Seville, 41013, Spain

  • Hospital Universitario de Canarias

    San Cristóbal de La Laguna, 38320, Spain

  • Hospital de la Santa Creu i Sant Pau

    Barcelona, 08025, Spain

  • Hôspital de la Timone

    Marseille, 13005, France

  • Institut Bergonié

    Bordeaux, 33076, France

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

    Barcelona, 08908, Spain

  • Institut Curie

    Paris, 75005, France

  • Institut Jules Bordet

    Anderlecht, 1070, Belgium

  • Institut de Cancérologie de l'Ouest - Angers

    Angers, Pays de la Loire Region, 49055, France

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

    Saint-Herblain, 44805, France

  • Instituto Portugues De Oncologia De Lisboa Francisco Gentil

    Lisbon, Lisbon District, 1099-023, Portugal

  • Instituto Português de Oncologia do Porto Francisco Gentil

    Porto, 4200-072, Portugal

  • Istituto Nazionale Tumori IRCCS Fondazione G. Pascale

    Naples, Naples, 80131, Italy

  • Istituto Nazionale Tumori Regina Elena

    Roma, 00144, Italy

  • Istituto Oncologico Veneto - IRCCS

    Padova, 35128, Italy

  • Istituto Ortopedico Rizzoli

    Bologna, 40136, Italy

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

    Candiolo, 10060, Italy

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

    Rozzano, Milan, 20089, Italy

  • LMU Klinikum - Campus Großhadern

    München, Bavaria, 81675, Germany

  • Leids Universitair Medisch Centrum (LUMC)

    Leiden, South Holland, 2333 ZA, Netherlands

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114, United States

  • Mayo Clinic - Jacksonville

    Jacksonville, Florida, 32224, United States

  • Mayo Clinic - Rochester

    Rochester, Minnesota, 55905, United States

  • Mayo Clinic Hospital - Phoenix

    Phoenix, Arizona, 85054, United States

  • Medizinische Hochschule Hannover

    Hanover, 30625, Germany

  • Medizinische Universität Innsbruck

    Innsbruck, 6020, Austria

  • Medizinische Universität Wien

    Vienna, 1090, Austria

  • Memorial Sloan Kettering Cancer Center - New York

    New York, New York, 10065, United States

  • Moffitt Cancer Center

    Tampa, Florida, 33612, United States

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

    Warsaw, Masovian Voivodeship, 02-781, Poland

  • Norris Comprehensive Cancer Center

    Los Angeles, California, 90033, United States

  • Ordensklinikum Linz GmbH Barmherzige Schwestern

    Linz, 4010, Austria

  • Oregon Health and Science University

    Portland, Oregon, 97239, United States

  • Oxford University Hospitals NHS Foundation Trust

    Oxford, OX3 7LE, United Kingdom

  • Precision NextGen Oncology & Research Center

    Beverly Hills, California, 90212, United States

  • START Madrid - CIOCC - HM Sanchinarro

    Madrid, 28050, Spain

  • Sarcoma Oncology Center

    Los Angeles, California, 90057, United States

  • Stanford University (Leland Stanford Junior University)

    Palo Alto, California, 94304, United States

  • Szpitale Pomorskie Spółka Z Ograniczoną Odpowiedzialnością

    Gdynia, Pomeranian Voivodeship, 81-519, Poland

  • The Christie NHS Foundation Trust

    Manchester, M20 4BX, United Kingdom

  • The Clatterbridge Cancer Centre NHS Foundation Trust

    Liverpool, L7 8YA, United Kingdom

  • The Royal Marsden NHS Foundation Trust

    London, SW3 6JJ, United Kingdom

  • UT Southwestern Harold C. Simmons Comprehensive Cancer Center

    Dallas, Texas, 75390-8562, United States

  • Unidade Local de Saúde de Coimbra

    Coimbra, 3000-075, Portugal

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

    Porto, 4050-342, Portugal

  • Universitaetsklinikum Graz - Universitätsklinik für Innere Medizin

    Graz, 8036, Austria

  • Universitair Ziekenhuis Bruseel

    Jette, Brussels Capital, 1090, Belgium

  • Universitair Ziekenhuis Leuven - Campus Gasthuisberg

    Leuven, 3000, Belgium

  • Universitatsklinikum Carl Gustav Carus Dresden

    Dresden, 01307, Germany

  • University College London Hospitals NHS Foundation Trust

    London, NW1 2BU, United Kingdom

  • University Hospital Birmingham NHS Foundation Trust

    Birmingham, B15 2GW, United Kingdom

  • University of Colorado Hospital - Anschutz Medical Campus

    Aurora, Colorado, 80045, United States

  • University of Michigan

    Ann Arbor, Michigan, 48109, United States

  • University of Pennsylvania Abramson Cancer Center

    Philadelphia, Pennsylvania, 19104, United States

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

    Pittsburgh, Pennsylvania, 15232, United States

  • University of Texas MD Anderson Cancer Center

    Houston, Texas, 77030, United States

  • Università Campus Bio-Medico di Roma

    Roma, 00128, Italy

  • Universitätsklinikum Heidelberg

    Heidelberg, 69120, Germany

  • Universitätsklinikum Münster

    Münster, 48149, Germany

  • Universitätsklinikum Tübingen

    Tübingen, 72016, Germany

  • Universitätsmedizin Mannheim

    Manheim, 68167, Germany

  • Universitätsspital Basel

    Basel, 4031, Switzerland

  • Vanderbilt - Ingram Cancer Center

    Nashville, Tennessee, 37232, United States

  • Washington University School of Medicine in St. Louis

    St Louis, Missouri, 63110, United States

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