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Combining lurbinectedin with doxorubicin for treating metastatic leiomyosarcoma

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

Phase 3 Interventional PharmaMar · NCT06088290

This study is testing if combining two cancer drugs, lurbinectedin and doxorubicin, can help people with metastatic leiomyosarcoma live longer without their cancer getting worse compared to using doxorubicin alone.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment450 (estimated)
Ages18 Years and up
SexAll
SponsorPharmaMar Industry-sponsored
Drugs / interventionschemotherapy, doxorubicin
Locations97 sites (Phoenix, Arizona and 96 other locations)
Trial IDNCT06088290 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to evaluate the effectiveness of lurbinectedin in combination with doxorubicin compared to doxorubicin alone as a first-line treatment for patients with metastatic leiomyosarcoma. The primary goal is to determine if this combination therapy can prolong progression-free survival as assessed by an Independent Review Committee. Participants must have a confirmed diagnosis of metastatic leiomyosarcoma and meet specific eligibility criteria, including adequate organ function and performance status. The study is designed to provide insights into a potentially more effective treatment regimen for this aggressive cancer.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 and older with a histologically confirmed diagnosis of metastatic leiomyosarcoma who have not received prior systemic therapy for their metastatic disease.

Not a fit: Patients who have previously received anthracycline chemotherapy or those with non-measurable disease may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment combination could significantly improve progression-free survival for patients with metastatic leiomyosarcoma.

How similar studies have performed: While this specific combination has not been extensively tested, similar approaches in oncology have shown promise in improving treatment outcomes for various cancers.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

1. Voluntary signed and dated written informed consent of the participants obtained before any study-specific procedure.
2. Age ≥ 18 years.
3. Histologically confirmed diagnosis of metastatic LMS, in participants not candidates for curative resection.
4. Radiologically measurable disease according to the Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1.
5. No previous systemic therapy for metastatic disease (i.e., first-line setting) and no previous anthracyclines. Note: prior chemotherapy (without anthracycline) in the context of adjuvant or neoadjuvant therapy is allowed. Prior line/s of hormone therapy in the adjuvant/metastatic setting are also allowed.
6. Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤ 1.
7. Adequate hematological, renal, metabolic and hepatic function:

   1. 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.
   2. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3.0 x upper limit of normal (ULN).
   3. Total bilirubin ≤ 1.5 x ULN or direct bilirubin ≤ ULN if total bilirubin is \> ULN.
   4. Albumin ≥ 3.0 g/dL.
   5. Calculated creatinine clearance (CrCL) ≥ 30 mL/min (using Cockcroft and Gault's formula).
   6. Left ventricular ejection fraction (LVEF) \> 50% assessed by multiple-gated acquisition scan (MUGA) or echocardiography (ECHO) or cardiac magnetic resonance imaging (MRI).
8. Wash-out periods:

   1. At least three weeks since last prior systemic treatment.
   2. At least three weeks since last prior major surgery and one week since last prior minor surgery (port placement is excluded from this wash-out period).
   3. At least two weeks since last prior radiotherapy.
9. Evidence of non-childbearing status for women of childbearing potential (WOCBP). WOCBP must agree to use a highly effective contraceptive measure up to seven months after treatment discontinuation. Fertile male participants with WOCBP partners should use condoms during treatment and for four months following the last investigational medicinal product (IMP) dose.

Exclusion Criteria:

1. Prior treatment with anthracyclines, lurbinectedin or trabectedin.
2. Known low grade leiomyosarcoma (i.e., grade I).
3. Known hypersensitivity to any of the components of the IV formulation of lurbinectedin or doxorubicin.
4. Concomitant diseases/conditions:

   1. History of cardiac disease: myocardial infarction or angina within the year prior to enrollment; severe vascular disease; or symptomatic arrhythmia despite ongoing treatment.
   2. Participants with any immunodeficiency, including those known to be infected by human immunodeficiency virus (HIV).
   3. Known chronic active hepatitis or cirrhosis. For Hepatitis B, this includes positive tests for both Hepatitis B surface antigen and quantitative Hepatitis B polymerase chain reaction (PCR). For Hepatitis C, this includes positive tests for both Hepatitis C antibody and quantitative Hepatitis C PCR.
   4. Active uncontrolled infection.
   5. Any other major illness that (including severe cardiovascular disease) or risk factors that, in the Investigator's judgment, will substantially increase the risk associated with the patient's participation in this study.
5. Use of strong inducers of CYP3A4 activity within two weeks prior to the first infusion of lurbinectedin.
6. Prior irradiation of a RECIST v.1.1 target lesion if only one target lesion is available, unless progression of the lesion has been confirmed.
7. Known myopathy (history of resolved steroid-induced myopathy is allowed).
8. History of malignancies other than LMS within three years prior to enrollment, except for malignancies with a negligible risk of metastasis or death (e.g., 5-year OS rate \>90%), such as adequately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, localized prostate cancer, non-muscle-invasive urothelial carcinomas, ductal carcinoma in situ, or stage I uterine cancer. Prior malignancies should have received curative treatment and should remain in remission. The Investigator should ensure, based on histology or clinical information, that the current metastatic sites are leiomyosarcoma and not recurrence of the original malignancy.
9. Limitation of the participant's ability to comply with the treatment or to follow-up the protocol.
10. Women who are pregnant or breast feeding and fertile participants (men and women) who are not using a highly effective method of contraception.
11. Participants in whom rapid tumor shrinkage is needed (e.g., when a tumor is close to a critical structure).

Where this trial is running

Phoenix, Arizona and 96 other locations

+47 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions LeiomyosarcomaOncology
Last reviewed 2026-06-10 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.