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

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…