Study of Lurbinectedin in Combination With Doxorubicin Versus Doxorubicin Alone as First-line Treatment in Participants With Metastatic Leiomyosarcoma (SaLuDo)

To join this study, you need to be at least 18 years old and have leiomyosarcoma that has spread to other parts of your body. Your doctors must have confirmed this diagnosis with a biopsy, and surgery to cure the cancer must not be an option for you at this time. Importantly, this should be your first treatment for the widespread cancer, and you shouldn't have had a specific type of chemotherapy called anthracyclines before, although previous hormone therapy or earlier chemotherapy that wasn't anthracycline-based (for example, if you had it before surgery) is generally allowed.

Your general health also plays a part. Doctors will check that your blood tests, kidney function, and liver function are within certain healthy ranges. Your heart needs to be strong enough, and you should be able to carry out most of your daily activities without much difficulty. There are also specific timeframes since your last cancer treatments or major surgeries that need to be met.

If you are a woman who could become pregnant, you'll need to confirm you're not pregnant and agree to use effective birth control throughout the study. All participants will need to read and sign a consent form, showing you understand what the study involves and agree to take part.

If you decide to join this study, you would primarily be receiving either the combination of Lurbinectedin and Doxorubicin, or Doxorubicin alone. The specific schedule for these medications, such as how often and for how long you'd receive them, will be explained by the study team. You would have regular visits to the clinic for treatments, detailed health checks, and blood tests to monitor your health and how you're responding to the treatment.

To see if the treatment is working, you would have scans (like X-rays or MRI) at specific times to measure your cancer. The total duration of your participation in the treatment phase of the study would depend on how your cancer responds and how you tolerate the medication. You would continue treatment as long as the doctors believe it's helping and you are feeling well enough. There would also be follow-up observations after you stop treatment to continue monitoring your health, potentially for several months or longer.