Study of Lurbinectedin in Combination With Doxorubicin Versus Doxorubicin Alone as First-line Treatment in Participants With Metastatic Leiomyosarcoma (SaLuDo)

Phase 3 Active not recruiting 469 enrolled PharmaMar

RandomizedParallel-groupOpen-labelTreatment

Summary

The primary objective of this phase III trial 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.

Timeline

Start: 2023-09-21
Primary completion: 2029-08-30
Completion: 2029-08-30

Publications

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. SaLudo: a randomized phase IIb/III study of lurbinectedin plus doxorubicin as first-line treatment in leiomyosarcoma. Future Oncol. 2025 Apr;21(8):943-951. doi: 10.1080/14796694.2025.2463798. Epub 2025 Feb 11.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Doxorubicin	Other / unclassified	25 mg/m2	Intravenous
Subject	Doxorubicin	Other / unclassified	50 mg/m2	Intravenous
Subject	Doxorubicin	Other / unclassified	75 mg/m2	Intravenous
Subject	Lurbinectedin	Other / unclassified	2.2 mg/m2	Intravenous
Subject	Lurbinectedin	Other / unclassified	3.2 mg/m2	Intravenous

Study of Lurbinectedin in Combination With Doxorubicin Versus Doxorubicin Alone as First-line Treatment in Participants With Metastatic Leiomyosarcoma (SaLuDo)

Summary

Timeline

Publications

Drugs

Indications