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

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; Axel Le Cesne

doi:10.1080/14796694.2025.2463798

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

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, Axel Le Cesne

Research output: Contribution to journal › Article › peer-review

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.

Original language	English
Pages (from-to)	943-951
Number of pages	9
Journal	Future Oncology
Volume	21
Issue number	8
DOIs	https://doi.org/10.1080/14796694.2025.2463798
Publication status	Published - 1 Jan 2025

Keywords

Leiomyosarcoma
doxorubicin
lurbinectedin
overall survival
phase IIb/III
progression-free survival
seamless adaptive design

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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. Y., Boggio, G., Fernandez, C., Nieto, A., Kahatt, C., Alfaro, V., & Le Cesne, A. (2025). SaLudo: a randomized phase IIb/III study of lurbinectedin plus doxorubicin as first-line treatment in leiomyosarcoma. Future Oncology, 21(8), 943-951. https://doi.org/10.1080/14796694.2025.2463798

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

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.",

keywords = "Leiomyosarcoma, doxorubicin, lurbinectedin, overall survival, phase IIb/III, progression-free survival, seamless adaptive design",

author = "Cote, {Gregory M.} and Chawla, {Sant P.} and George Demetri and Bernd Kasper and Jones, {Robin L.} and Broto, {Javier Martin} and Joseph Wooley and Weiss, {Mia C.} and Salvatore Tafuto and Giuseppe Badalamenti and Irene Carrasco and Paloma Peinado and Blay, {Jean Yves} and Gaston Boggio and Cristian Fernandez and Antonio Nieto and Carmen Kahatt and Vicente Alfaro and {Le Cesne}, Axel",

note = "Publisher Copyright: {\textcopyright} 2025 The Author(s). Published by Informa UK Limited, trading as Taylor & Francis Group.",

year = "2025",

month = jan,

day = "1",

doi = "10.1080/14796694.2025.2463798",

language = "English",

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Cote, GM, Chawla, SP, Demetri, G, Kasper, B, Jones, RL, Broto, JM, Wooley, J, Weiss, MC, Tafuto, S, Badalamenti, G, Carrasco, I, Peinado, P, Blay, JY, Boggio, G, Fernandez, C, Nieto, A, Kahatt, C, Alfaro, V & Le Cesne, A 2025, 'SaLudo: a randomized phase IIb/III study of lurbinectedin plus doxorubicin as first-line treatment in leiomyosarcoma', Future Oncology, vol. 21, no. 8, pp. 943-951. https://doi.org/10.1080/14796694.2025.2463798

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T2 - a randomized phase IIb/III study of lurbinectedin plus doxorubicin as first-line treatment in leiomyosarcoma

AU - Cote, Gregory M.

AU - Chawla, Sant P.

AU - Demetri, George

AU - Kasper, Bernd

AU - Jones, Robin L.

AU - Broto, Javier Martin

AU - Wooley, Joseph

AU - Weiss, Mia C.

AU - Tafuto, Salvatore

AU - Badalamenti, Giuseppe

AU - Carrasco, Irene

AU - Peinado, Paloma

AU - Blay, Jean Yves

AU - Boggio, Gaston

AU - Fernandez, Cristian

AU - Nieto, Antonio

AU - Kahatt, Carmen

AU - Alfaro, Vicente

AU - Le Cesne, Axel

PY - 2025/1/1

Y1 - 2025/1/1

N2 - 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.

AB - 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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KW - doxorubicin

KW - lurbinectedin

KW - overall survival

KW - phase IIb/III

KW - progression-free survival

KW - seamless adaptive design

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U2 - 10.1080/14796694.2025.2463798

DO - 10.1080/14796694.2025.2463798

M3 - Article

C2 - 39932221

AN - SCOPUS:85218815796

SN - 1479-6694

VL - 21

SP - 943

EP - 951

JO - Future Oncology

JF - Future Oncology

IS - 8

ER -

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

Abstract

Keywords

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