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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| Hauptverfasser: | , , , , , , , , , , , , , , , , , , |
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| Dokumenttyp: | Article (Journal) |
| Sprache: | Englisch |
| Veröffentlicht: |
Mar 2025
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| In: |
Future oncology
Year: 2025, Jahrgang: 21, Heft: 8, Pages: 943-951 |
| ISSN: | 1744-8301 |
| DOI: | 10.1080/14796694.2025.2463798 |
| Online-Zugang: | 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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| Verfasserangaben: | 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 |
MARC
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| 245 | 1 | 0 | |a SaLudo: a randomized phase IIb/III study of lurbinectedin plus doxorubicin as first-line treatment in leiomyosarcoma |c 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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| 520 | |a 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. | ||
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