OncoMatch/Clinical Trials/NCT06088290
Study of Lurbinectedin in Combination With Doxorubicin Versus Doxorubicin Alone as First-line Treatment in Participants With Metastatic Leiomyosarcoma (SaLuDo)
Is NCT06088290 recruiting? Yes, currently enrolling (May 2026). This Phase 3 trial studies multiple treatments including Lurbinectedin and Doxorubicin for leiomyosarcoma.
Treatment: Lurbinectedin · Doxorubicin — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Sarcoma
Disease stage
Required: Stage IV
Metastatic disease required
Histologically confirmed diagnosis of metastatic LMS, in participants not candidates for curative resection.
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: anthracycline
Prior treatment with anthracyclines
Cannot have received: (lurbinectedin, trabectedin)
Prior treatment with lurbinectedin or trabectedin
Lab requirements
Blood counts
Hemoglobin ≥ 9.0 g/dL (participants may have received prior red blood cell transfusion); ANC ≥ 2.0 x 10^9/L; platelet count ≥ 100 x 10^9/L
Kidney function
Calculated creatinine clearance (CrCL) ≥ 30 mL/min (using Cockcroft and Gault's formula)
Liver function
ALT and AST ≤ 3.0 x ULN; total bilirubin ≤ 1.5 x ULN or direct bilirubin ≤ ULN if total bilirubin is > ULN; albumin ≥ 3.0 g/dL
Cardiac function
Left ventricular ejection fraction (LVEF) > 50% assessed by MUGA, ECHO, or cardiac MRI
Adequate hematological, renal, metabolic and hepatic function: Hemoglobin ≥ 9.0 g/dL (participants may have received prior red blood cell [Red Blood Cell] transfusion); absolute neutrophil count (ANC) ≥ 2.0 x 10^9/L, and platelet count ≥ 100 x 10^9/L. ALT and AST ≤ 3.0 x ULN. Total bilirubin ≤ 1.5 x ULN or direct bilirubin ≤ ULN if total bilirubin is > ULN. Albumin ≥ 3.0 g/dL. Calculated creatinine clearance (CrCL) ≥ 30 mL/min (using Cockcroft and Gault's formula). Left ventricular ejection fraction (LVEF) > 50% assessed by MUGA or ECHO or cardiac MRI.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Mayo Clinic Hospital - Phoenix · Phoenix, Arizona
- Precision NextGen Oncology & Research Center · Beverly Hills, California
- Cedars-Sinai Medical Center · Los Angeles, California
- Norris Comprehensive Cancer Center · Los Angeles, California
- Sarcoma Oncology Center · Los Angeles, California
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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