Actively Recruiting
Study of Lurbinectedin in Combination With Doxorubicin Versus Doxorubicin Alone as First-line Treatment in Participants With Metastatic Leiomyosarcoma (SaLuDo)
Led by PharmaMar · Updated on 2026-04-17
450
Participants Needed
97
Research Sites
310 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Study of Lurbinectedin in Combination With Doxorubicin Versus Doxorubicin Alone as First-line Treatment in Participants With Metastatic Leiomyosarcoma (SaLuDo)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent before any study procedures
- Age 18 years or older
- Histologically confirmed metastatic leiomyosarcoma not suitable for curative surgery
- Measurable disease by RECIST v1.1 criteria
- No prior systemic therapy for metastatic disease and no previous anthracycline treatment
- ECOG performance status of 0 or 1
- Adequate blood counts, liver, kidney, and metabolic function as specified
- Left ventricular ejection fraction above 50% by heart imaging
- Required wash-out periods from previous treatments and surgeries
- Women of childbearing potential must use effective contraception during and after treatment; fertile men must use condoms during and after treatment
You will not qualify if you...
- Previous treatment with anthracyclines, lurbinectedin, or trabectedin
- Diagnosis of low grade (grade I) leiomyosarcoma
- Known allergy to components of lurbinectedin or doxorubicin
- History of recent or severe cardiac disease
- Immunodeficiency including HIV infection
- Chronic active hepatitis or cirrhosis
- Active uncontrolled infection
- Major illnesses increasing participation risk per investigator judgment
- Use of strong CYP3A4 inducers before lurbinectedin treatment
- Prior radiation to a target lesion unless progression confirmed
- Known myopathy (except resolved steroid-induced myopathy)
- Other malignancies within 3 years except certain low-risk cancers
- Inability to comply with treatment or follow-up
- Pregnancy, breastfeeding, or not using effective contraception
- Need for rapid tumor shrinkage due to tumor location
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 97 locations
1
Mayo Clinic Hospital - Phoenix
Phoenix, Arizona, United States, 85054
Actively Recruiting
2
Precision NextGen Oncology & Research Center
Beverly Hills, California, United States, 90212
Actively Recruiting
3
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90025
Not Yet Recruiting
4
Norris Comprehensive Cancer Center
Los Angeles, California, United States, 90033
Actively Recruiting
5
Sarcoma Oncology Center
Los Angeles, California, United States, 90057
Actively Recruiting
6
Stanford University (Leland Stanford Junior University)
Palo Alto, California, United States, 94304
Actively Recruiting
7
University of Colorado Hospital - Anschutz Medical Campus
Aurora, Colorado, United States, 80045
Actively Recruiting
8
Mayo Clinic - Jacksonville
Jacksonville, Florida, United States, 32224
Actively Recruiting
9
Moffitt Cancer Center
Tampa, Florida, United States, 33612
Actively Recruiting
10
Augusta University Georgia Cancer Center
Augusta, Georgia, United States, 30912
Actively Recruiting
11
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Actively Recruiting
12
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02215
Actively Recruiting
13
University of Michigan
Ann Arbor, Michigan, United States, 48109
Actively Recruiting
14
Mayo Clinic - Rochester
Rochester, Minnesota, United States, 55905
Actively Recruiting
15
Washington University School of Medicine in St. Louis
St Louis, Missouri, United States, 63110
Actively Recruiting
16
Memorial Sloan Kettering Cancer Center - New York
New York, New York, United States, 10065
Actively Recruiting
17
Cleveland Clinic Main Campus
Cleveland, Ohio, United States, 44195
Completed
18
Oregon Health and Science University
Portland, Oregon, United States, 97239
Actively Recruiting
19
University of Pennsylvania Abramson Cancer Center
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
20
University of Pittsburgh Medical Center (UPMC) Hillman Cancer Center
Pittsburgh, Pennsylvania, United States, 15232
Actively Recruiting
21
Vanderbilt - Ingram Cancer Center
Nashville, Tennessee, United States, 37232
Actively Recruiting
22
UT Southwestern Harold C. Simmons Comprehensive Cancer Center
Dallas, Texas, United States, 75390-8562
Actively Recruiting
23
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
24
Fred Hutchinson Cancer Center - Seattle Cancer Care Alliance (SCCA) Location
Seattle, Washington, United States, 98109
Actively Recruiting
25
Universitaetsklinikum Graz - Universitätsklinik für Innere Medizin
Graz, Austria, 8036
Actively Recruiting
26
Medizinische Universität Innsbruck
Innsbruck, Austria, 6020
Actively Recruiting
27
Ordensklinikum Linz GmbH Barmherzige Schwestern
Linz, Austria, 4010
Not Yet Recruiting
28
Medizinische Universität Wien
Vienna, Austria, 1090
Actively Recruiting
29
Universitair Ziekenhuis Bruseel
Jette, Brussels Capital, Belgium, 1090
Actively Recruiting
30
Institut Jules Bordet
Anderlecht, Belgium, 1070
Actively Recruiting
31
Cliniques Universitaires Saint-Luc
Brussels, Belgium, 1200
Actively Recruiting
32
Universitair Ziekenhuis Leuven - Campus Gasthuisberg
Leuven, Belgium, 3000
Actively Recruiting
33
Centre Léon Bérard
Lyon, Auvergne-Rhône-Alpes, France, 69008
Actively Recruiting
34
Centre Hospitalier Régional et Universitaire de Besançon - Hôpital Jean-Minjoz
Besançon, Doubs, France, 25030
Actively Recruiting
35
Institut de Cancérologie de l'Ouest - Angers
Angers, Pays de la Loire Region, France, 49055
Actively Recruiting
36
Centre Antoine Lacassagne
Nice, Provence-Alpes-Côte d'Azur Region, France, 06189
Actively Recruiting
37
Institut Bergonié
Bordeaux, France, 33076
Actively Recruiting
38
Centre de Lutte contre le Cancer - Centre Oscar Lambret
Lille, France, 59000
Active, Not Recruiting
39
Centre Hospitalier Universitaire Dupuytren 1
Limoges, France, 87042
Actively Recruiting
40
Hôspital de la Timone
Marseille, France, 13005
Completed
41
Institut Curie
Paris, France, 75005
Actively Recruiting
42
Centre Hospitalier Universitaire de Poitiers
Poitiers, France, 86000
Actively Recruiting
43
Centre Eugène Marquis
Rennes, France, 35042
Actively Recruiting
44
Institut de Cancérologie de l'Ouest - Saint-Herblain - Site René Gauducheau
Saint-Herblain, France, 44805
Actively Recruiting
45
Gustave Roussy
Villejuif, France, 94805
Actively Recruiting
46
LMU Klinikum - Campus Großhadern
München, Bavaria, Germany, 81675
Actively Recruiting
47
Helios Klinikum Bad Saarow
Bad Saarow, Germany, 15526
Actively Recruiting
48
Universitatsklinikum Carl Gustav Carus Dresden
Dresden, Germany, 01307
Actively Recruiting
49
Medizinische Hochschule Hannover
Hanover, Germany, 30625
Actively Recruiting
50
Universitätsklinikum Heidelberg
Heidelberg, Germany, 69120
Active, Not Recruiting
51
Universitätsmedizin Mannheim
Manheim, Germany, 68167
Actively Recruiting
52
Universitätsklinikum Münster
Münster, Germany, 48149
Actively Recruiting
53
Universitätsklinikum Tübingen
Tübingen, Germany, 72016
Actively Recruiting
54
Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) - Istituto Clinico Humanitas
Rozzano, Milan, Italy, 20089
Actively Recruiting
55
Istituto Nazionale Tumori IRCCS Fondazione G. Pascale
Naples, Naples, Italy, 80131
Actively Recruiting
56
Centro di Riferimento Oncologico
Aviano, Italy, 33081
Actively Recruiting
57
Istituto Ortopedico Rizzoli
Bologna, Italy, 40136
Actively Recruiting
58
Azienda Ospedaliero-Universitaria di Bologna - Policlinico Sant Orsola-Malpighi
Bologna, Italy
Actively Recruiting
59
Istituto di Candiolo - Fondazione del Piemonte per l'Oncologia
Candiolo, Italy, 10060
Actively Recruiting
60
Azienda Ospedaliero - Universitaria San Luigi Gonzaga
Orbassano, Italy, 10043
Actively Recruiting
61
Istituto Oncologico Veneto - IRCCS
Padova, Italy, 35128
Actively Recruiting
62
Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone
Palermo, Italy, 90127
Actively Recruiting
63
Università Campus Bio-Medico di Roma
Roma, Italy, 00128
Actively Recruiting
64
Istituto Nazionale Tumori Regina Elena
Roma, Italy, 00144
Actively Recruiting
65
Azienda Ospedaliero-Universitaria Citta della Salute e della Scienza di Torino
Torino, Italy, 10126
Completed
66
Het Nederlands Kanker Instituut
Amsterdam, North Holland, Netherlands, 1066 CX
Actively Recruiting
67
Leids Universitair Medisch Centrum (LUMC)
Leiden, South Holland, Netherlands, 2333 ZA
Actively Recruiting
68
Narodowy Instytut Onkologii im. Marii Skłodowskiej-Curie - Państwowy Instytut Badawczy
Warsaw, Masovian Voivodeship, Poland, 02-781
Actively Recruiting
69
Szpitale Pomorskie Spółka Z Ograniczoną Odpowiedzialnością
Gdynia, Pomeranian Voivodeship, Poland, 81-519
Actively Recruiting
70
Instituto Portugues De Oncologia De Lisboa Francisco Gentil
Lisbon, Lisbon District, Portugal, 1099-023
Actively Recruiting
71
Unidade Local de Saúde de Coimbra
Coimbra, Portugal, 3000-075
Not Yet Recruiting
72
Unidade Local de Saúde de Santo António, E.P.E - Hospital Geral de Santo António
Porto, Portugal, 4050-342
Actively Recruiting
73
Instituto Português de Oncologia do Porto Francisco Gentil
Porto, Portugal, 4200-072
Actively Recruiting
74
Complejo Hospitalario Universitario A Coruña
A Coruña, Spain, 15006
Actively Recruiting
75
Complejo Hospitalario Universitario de Santiago (CHUS)
A Coruña, Spain, 15006
Actively Recruiting
76
Hospital de la Santa Creu i Sant Pau
Barcelona, Spain, 08025
Actively Recruiting
77
Hospital Universitari Vall d'Hebrón
Barcelona, Spain, 08035
Actively Recruiting
78
Institut Català d'Oncologia - Hospital Duran i Reynals (ICO L'Hospitalet)
Barcelona, Spain, 08908
Actively Recruiting
79
Hospital General Universitario Gregorio Marañón
Madrid, Spain, 28007
Actively Recruiting
80
Hospital Clínico San Carlos
Madrid, Spain, 28040
Actively Recruiting
81
Hospital Universitario Fundación Jiménez Díaz
Madrid, Spain, 28040
Actively Recruiting
82
Hospital Universitario La Paz
Madrid, Spain, 28046
Completed
83
START Madrid - CIOCC - HM Sanchinarro
Madrid, Spain, 28050
Actively Recruiting
84
Hospital Universitario de Canarias
San Cristóbal de La Laguna, Spain, 38320
Not Yet Recruiting
85
Hospital Universitario Virgen del Rocío
Seville, Spain, 41013
Actively Recruiting
86
Hospital Clínico Universitario de Valencia
Valencia, Spain, 46010
Actively Recruiting
87
Hospital Universitari i Politècnic La Fe
Valencia, Spain, 46026
Actively Recruiting
88
Hospital Universitario Miguel Servet
Zaragoza, Spain, 50009
Actively Recruiting
89
Universitätsspital Basel
Basel, Switzerland, 4031
Completed
90
Centre Hospitalier Universitaire Vaudois Lausanne
Lausanne, Switzerland, 1011
Actively Recruiting
91
University Hospital Birmingham NHS Foundation Trust
Birmingham, United Kingdom, B15 2GW
Actively Recruiting
92
Cambridge University Hospitals NHS Foundation Trust
Cambridge, United Kingdom, CB2 0QQ
Not Yet Recruiting
93
The Clatterbridge Cancer Centre NHS Foundation Trust
Liverpool, United Kingdom, L7 8YA
Actively Recruiting
94
University College London Hospitals NHS Foundation Trust
London, United Kingdom, NW1 2BU
Actively Recruiting
95
The Royal Marsden NHS Foundation Trust
London, United Kingdom, SW3 6JJ
Actively Recruiting
96
The Christie NHS Foundation Trust
Manchester, United Kingdom, M20 4BX
Actively Recruiting
97
Oxford University Hospitals NHS Foundation Trust
Oxford, United Kingdom, OX3 7LE
Actively Recruiting
Research Team
G
Gaston Federico Boggio, M.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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