SaLudo: a randomized phase IIb/III study of lurbinectedin plus doxorubicin as first-line treatment in leiomyosarcoma
- Authors: Cote, G.M.; Chawla, S.P.; Demetri, G.; Kasper, B.; Jones, R.L.; Broto, J.M.; Wooley, J.; Weiss, M.C.; Tafuto, S.; Badalamenti, G.; Carrasco, I.; Peinado, P.; Blay, J.; Boggio, G.; Fernandez, C.; Nieto, A.; Kahatt, C.; Alfaro, V.; Le Cesne, A.
- Publication year: 2025
- Type: Articolo in rivista
- OA Link: http://hdl.handle.net/10447/696952
Abstract
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.