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SaLudo: a randomized phase IIb/III study of lurbinectedin plus doxorubicin as first-line treatment in leiomyosarcoma

Previous phase I/II trials indicate promising activity of lurbinectedin plus doxorubicin (DOX) in leiomyosarcoma (LMS). We describe here the rationale and design of SaLuDo, an open label, randomized, multicenter, seamless phase IIb/III study to evaluate the antitumor activity and safety of lurbinect...

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Main Authors: Cote, Gregory M. (Author) , Chawla, Sant P. (Author) , Demetri, George (Author) , Kasper, Bernd (Author) , Jones, Robin L. (Author) , Broto, Javier Martin (Author) , Wooley, Joseph (Author) , Weiss, Mia C. (Author) , Tafuto, Salvatore (Author) , Badalamenti, Giuseppe (Author) , Carrasco, Irene (Author) , Peinado, Paloma (Author) , Blay, Jean-Yves (Author) , Boggio, Gaston (Author) , Fernandez, Cristian (Author) , Nieto, Antonio (Author) , Kahatt, Carmen (Author) , Alfaro, Vicente (Author) , Le Cesne, Axel (Author)
Format: Article (Journal)
Language:English
Published: Mar 2025
In: Future oncology
Year: 2025, Volume: 21, Issue: 8, Pages: 943-951
ISSN:1744-8301
DOI:10.1080/14796694.2025.2463798
Online Access:Verlag, kostenfrei, Volltext: https://doi.org/10.1080/14796694.2025.2463798
Verlag, kostenfrei, Volltext: https://www.tandfonline.com/doi/full/10.1080/14796694.2025.2463798
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Author Notes:Gregory M. Cote, Sant P. Chawla, George Demetri, Bernd Kasper, Robin L. Jones, Javier Martin Broto, Joseph Wooley, Mia C. Weiss, Salvatore Tafuto, Giuseppe Badalamenti, Irene Carrasco, Paloma Peinado, Jean-Yves Blay, Gaston Boggio, Cristian Fernandez, Antonio Nieto, Carmen Kahatt, Vicente Alfaro, andAxel Le Cesne
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Summary:Previous phase I/II trials indicate promising activity of lurbinectedin plus doxorubicin (DOX) in leiomyosarcoma (LMS). We describe here the rationale and design of SaLuDo, an open label, randomized, multicenter, seamless phase IIb/III study to evaluate the antitumor activity and safety of lurbinectedin plus DOX versus DOX alone in the first-line setting of metastatic LMS. The phase IIb stage will evaluate two schedules of the combination for the phase III stage given every 3 weeks (q3wk): DOX 50 mg/m2 plus lurbinectedin 2.2 mg/m2, and DOX 25 mg/m2 plus lurbinectedin 3.2 mg/m2. The control arm will be DOX 75 mg/m2 q3wk. The primary endpoint is progression-free survival by independent review; overall survival is the key secondary endpoint. Clinical trial registration: www.clinicaltrials.gov identifier is NCT06088290.
Item Description:Online veröffentlicht: 11. Februar 2025
Gesehen am 23.07.2025
Physical Description:Online Resource
ISSN:1744-8301
DOI:10.1080/14796694.2025.2463798

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