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Brief Title: Study of Lurbinectedin in Combination With Doxorubicin Versus Doxorubicin Alone as First-line Treatment in Participants With Metastatic Leiomyosarcoma
Official Title: Randomized, Controlled, Open-label, Phase IIb/III Study of Lurbinectedin in Combination With Doxorubicin Versus Doxorubicin Alone as First-line Treatment in Patients With Metastatic Leiomyosarcoma
Study ID: NCT06088290
Brief Summary: The primary objective of this phase IIb/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.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Mayo Clinic Hospital - Phoenix, Phoenix, Arizona, United States
Sarcoma Oncology Center, Los Angeles, California, United States
Mayo Clinic - Jacksonville, Jacksonville, Florida, United States
Massachusetts General Hospital, 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, Saint Louis, Missouri, United States
Cleveland Clinic Main Campus, Cleveland, Ohio, United States
University of Pennsylvania Abramson Cancer Center, Philadelphia, Pennsylvania, United States
Universitaetsklinikum Graz - Universitätsklinik für Innere Medizin, Graz, , Austria
Institut Jules Bordet, Anderlecht, , Belgium
Institut de Cancérologie de l'Ouest - Angers, Angers cedex 02, Pays De La Loire, France
Centre Antoine Lacassagne, Nice Cedex 2, Provence Alpes Cote D-Azur, France
Centre Léon Bérard, Lyon, Rhone-Alpes, France
Institut Bergonié, Bordeaux, , France
Centre de Lutte contre le Cancer - Centre Oscar Lambre, Lille, , France
Centre Hospitalier Universitaire Dupuytren 1, Limoges, , France
Hôspital de la Timone, Marseille Cedex 5, , France
Centre Eugène Marquis, Rennes Cedex, , France
Institut de Cancérologie de l'Ouest - Saint-Herblain - Site René Gauducheau, Saint-Herblain, , France
Helios Klinikum Bad Saarow, Bad Saarow, , Germany
Universitätsklinikum Münster, Münster, , Germany
Universitätsklinikum Tübingen, Tübingen, , Germany
Istituto Nazionale Tumori IRCCS Fondazione G. Pascale, Napoli, Naples, Italy
Istituto di Candiolo - Fondazione del Piemonte per l'Oncologia, Candiolo, , Italy
Azienda Ospedaliero - Universitaria San Luigi Gonzaga, Orbassano, , Italy
Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone, Palermo, , Italy
Università Campus Bio-Medico di Roma, Roma, , Italy
Account Istituto Nazionale Tumori Regina Elena, Roma, , Italy
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 Universitario de Canarias, La Laguna, , 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 Virgen del Rocío, Sevilla, , Spain
Hospital Clínico Universitario de Valencia, Valencia, , Spain
Hospital Universitario Miguel Servet, Zaragoza, , Spain
The Clatterbridge Cancer Centre NHS Foundation Trust, Liverpool, , United Kingdom
University College London Hospitals NHS Foundation Trust, London, , United Kingdom
The Christie NHS Foundation Trust, Manchester, , United Kingdom