Randomized, Controlled, Open-label, Phase IIb/III Study of Lurbinectedin in Combination with Doxorubicin versus Doxorubicin Alone as First-line Treatment in Patients with Metastatic Leiomyosarcoma
The primary objective of this phase IIb/III study is to evaluate whether the combination of lurbinectedin plus doxorubicin given as first line treatment for metastatic LMS prolongs the progression-free survival (PFS) by Independent Review Committee (IRC) when compared to doxorubicin administered as a single agent.
Why this Research Matters
The goal of of this phase IIb/III study is to evaluate whether the combination of lurbinectedin plus doxorubicin given as first line treatment for metastatic LMS prolongs the progression-free survival (PFS)
Who can Participate
Inclusion: - Histologically confirmed diagnosis of metastatic LMS, in patients not candidates for curative resection. - 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. Exclusion: - Prior treatment with anthracyclines, lurbinectedin or trabectedin. - Known low grade leiomyosarcoma (i.e., grade I). - Prior irradiation if only one target lesion (i.e., measurable) is available, unless progression of the lesion has been confirmed. Detailed eligibility criteria is available on clinicaltrials.gov. These requirements will be discussed with your doctor and/or study representative. Click the NCT number link below to learn more about this study on ClinicalTrials.gov
Study ID
Protocol Number: 25-0027
More information available at ClinicalTrials.gov: NCT06088290
Meet the Team
Principal Investigator