Trials / Recruiting
RecruitingNCT06088290
Study of Lurbinectedin in Combination With Doxorubicin Versus Doxorubicin Alone as First-line Treatment in Participants With Metastatic Leiomyosarcoma (SaLuDo)
Randomized, Controlled, Open-label, Phase III Study of Lurbinectedin in Combination With Doxorubicin Versus Doxorubicin Alone as First-line Treatment in Patients With Metastatic Leiomyosarcoma
- Status
- Recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 450 (estimated)
- Sponsor
- PharmaMar · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The primary objective of this phase III study 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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Lurbinectedin | IV Infusion |
| DRUG | Doxorubicin | Short IV push or bolus (according to label) |
Timeline
- Start date
- 2023-09-21
- Primary completion
- 2029-08-30
- Completion
- 2029-08-30
- First posted
- 2023-10-18
- Last updated
- 2026-04-17
Locations
97 sites across 12 countries: United States, Austria, Belgium, France, Germany, Italy, Netherlands, Poland, Portugal, Spain, Switzerland, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT06088290. Inclusion in this directory is not an endorsement.