Study on Lurbinectedin and Doxorubicin Combination vs. Doxorubicin Alone for First-line Treatment in Metastatic Leiomyosarcoma

Inclusion Criteria

• Must provide written consent to participate.
• Age 18 or older.
• Confirmed diagnosis of metastatic leiomyosarcoma.
• Cancer that can be measured by scans.
• No previous treatment for metastatic cancer and no prior use of anthracyclines (a type of chemotherapy).
• Good overall health with a performance status of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
• Adequate blood, kidney, liver, and heart function as shown by specific medical tests.
• Must have waited a certain period after any previous treatments or surgeries before starting the study.
• Women of childbearing potential must show they are not pregnant.

Exclusion Criteria

• Previous treatment with anthracyclines, lurbinectedin, or trabectedin.
• Low-grade leiomyosarcoma.
• Allergies to lurbinectedin or doxorubicin.
• Certain heart conditions or diseases affecting the immune system.
• Active infections or other serious illnesses.
• Use of certain medications that affect liver enzymes within two weeks before starting the study.
• Only one measurable cancer lesion that has been treated with radiation, unless it has worsened.
• Muscle diseases.
• History of other cancers, unless they have been successfully treated and not returned for at least three years.
• Difficulty following the study procedures.
• Pregnant or breastfeeding women, and men or women not using effective birth control.