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Study of Lurbinectedin and Doxorubicin for First-line Treatment in Patients with Metastatic Leiomyosarcoma

Verified siteRegistered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying a type of cancer called metastatic leiomyosarcoma, which is a cancer that starts in smooth muscle tissue and has spread to other parts of the body. The study is testing a new treatment combination to see if it can help patients with this condition. The treatment being studied includes a drug called lurbinectedin, which is being tested in combination with another drug called doxorubicin hydrochloride. Doxorubicin hydrochloride is already used in cancer treatment, and this study aims to find out if adding lurbinectedin can improve outcomes for patients.

The purpose of the study is to determine if the combination of lurbinectedin and doxorubicin hydrochloride can help patients live longer without their cancer getting worse, compared to using doxorubicin hydrochloride alone. Patients participating in the study will receive these medications through an intravenous (IV) infusion, which means the drugs are given directly into a vein. The study will compare the effects of the combination treatment to the effects of doxorubicin hydrochloride alone, to see which is more effective as a first-line treatment for metastatic leiomyosarcoma.

Participants in the study will be randomly assigned to receive either the combination of lurbinectedin and doxorubicin hydrochloride or doxorubicin hydrochloride alone. The study will be conducted over a period of time, and patients will be monitored to see how their cancer responds to the treatment. The study will also look at the safety of the treatments and any side effects that may occur. This research is important to help find better ways to treat metastatic leiomyosarcoma and improve the quality of life for patients with this condition.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, the patient will be randomly assigned to one of two groups: one receiving a combination of lurbinectedin and doxorubicin, and the other receiving doxorubicin alone.

    The study is designed to evaluate the effectiveness of these treatments in patients with metastatic leiomyosarcoma, a type of cancer that has spread to other parts of the body.

  2. Step 2

    Treatment administration

    The patient will receive the assigned treatment intravenously. This means the medication will be delivered directly into the bloodstream through a vein.

    For those in the combination group, lurbinectedin and doxorubicin will be administered together. The specific dosage and frequency will be determined by the study protocol.

  3. Step 3

    Monitoring and assessments

    Throughout the study, the patient's health and response to treatment will be closely monitored. This includes regular medical assessments and imaging tests to measure the size and spread of the cancer.

    The patient's quality of life will also be evaluated using a questionnaire designed to capture their experiences and any side effects they may encounter.

  4. Step 4

    Follow-up and conclusion

    The study will continue until the estimated end date in April 2029, or until the patient completes their treatment course.

    After the treatment phase, follow-up visits will be scheduled to monitor the patient's long-term health and any potential late effects of the treatment.

Who can join the trial?

19 criteria

  • The patient must voluntarily sign and date a written informed consent form before any study-specific procedures begin.
  • The patient must be at least 18 years old.
  • The patient must have a confirmed diagnosis of **metastatic leiomyosarcoma** (LMS), which means the cancer has spread to other parts of the body, and they are not candidates for surgery that could cure the disease.
  • The patient must have a disease that can be measured using imaging techniques, according to a specific set of guidelines called **RECIST v.1.1**.
  • The patient must not have received any previous systemic therapy for metastatic disease, meaning this is their first treatment for cancer that has spread. They also must not have received a type of drug called **anthracyclines** before. However, previous chemotherapy without anthracyclines is allowed if it was given as part of treatment before or after surgery.
  • The patient must have an **ECOG performance status** of 0 or 1, which means they are fully active or have some symptoms but can still carry out light work.
  • The patient must have adequate blood, kidney, liver, and heart function, as shown by specific medical tests:
  • **Hemoglobin** level of at least 9.0 g/dL. Patients may have received a blood transfusion before.
  • **Absolute neutrophil count** (ANC) of at least 2.0 x 109/L, and **platelet count** of at least 100 x 109/L.
  • **Alanine aminotransferase** (ALT) and **aspartate aminotransferase** (AST) levels no more than 3 times the upper limit of normal.
  • **Total bilirubin** level within normal limits, or **direct bilirubin** within normal limits if total bilirubin is higher.
  • **Albumin** level of at least 3.0 g/dL.
  • **Creatinine clearance** of at least 30 mL/min, which is a measure of kidney function.
  • **Left ventricular ejection fraction** (LVEF) greater than 50%, which is a measure of heart function, assessed by specific heart imaging tests.
  • The patient must have waited a certain amount of time since their last treatment or surgery:
  • At least three weeks since the last systemic treatment.
  • At least three weeks since major surgery and one week since minor surgery.
  • At least two weeks since the last radiotherapy session.
  • Women who can have children must show evidence that they are not currently able to become pregnant. They must agree to use a highly effective form of birth control during the study and for seven months after stopping treatment. Men with partners who can have children should use condoms during treatment and for four months after the last dose of the study drug.

Who cannot join the trial?

8 criteria

  • Patients who have a different type of cancer other than metastatic leiomyosarcoma. Metastatic means the cancer has spread to other parts of the body.
  • Patients who have already received treatment for their metastatic leiomyosarcoma. This study is for those who have not yet been treated.
  • Patients who are not within the specified age range for the study. The study has specific age requirements.
  • Patients who are not able to follow the study procedures or attend the required visits.
  • Patients who have other serious health conditions that might interfere with the study treatment.
  • Patients who are pregnant or breastfeeding, as the study treatment might affect the baby.
  • Patients who are participating in another clinical trial at the same time.
  • Patients who have allergies or reactions to the study medications or similar drugs.
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Investigated drugs

  • Lurbinectedin

    is a medication being studied for its potential to treat metastatic leiomyosarcoma, a type of cancer. In this trial, it is used in combination with another drug to see if it can help slow down the progression of the disease.

  • Doxorubicin

    is a chemotherapy drug that is commonly used to treat various types of cancer, including leiomyosarcoma. In this study, it is used both alone and in combination with lurbinectedin to determine its effectiveness in treating metastatic leiomyosarcoma.

What is already known about the treatment

  • Lurbinectedin

    Lurbinectedin is administered intravenously and is currently being studied in clinical trials for its effectiveness in treating metastatic leiomyosarcoma. It is not yet widely used in standard medical practice but is gaining attention in medical literature for its potential benefits. The main therapeutic indication for lurbinectedin is as a treatment for metastatic leiomyosarcoma, often in combination with other drugs. At the molecular level, lurbinectedin works by binding to the DNA in cancer cells, disrupting their replication and leading to cell death. It is classified as an antineoplastic agent, specifically a DNA-binding agent.

  • Doxorubicin

    Doxorubicin is administered intravenously and is a well-established medication in the treatment of various cancers, including metastatic leiomyosarcoma. It is widely recognized in medical literature and is often used as a standard treatment option. The main therapeutic indication for doxorubicin is as a chemotherapy agent for different types of cancer. Its mechanism of action involves intercalating into DNA, inhibiting the enzyme topoisomerase II, and generating free radicals, which ultimately leads to cancer cell death. Doxorubicin is classified as an anthracycline antibiotic and antineoplastic agent.

Investigated diseases

Metastatic Leiomyosarcoma – Metastatic leiomyosarcoma is a rare type of cancer that originates in smooth muscle tissue and has spread to other parts of the body. It often begins in the uterus, stomach, or intestines, but can also arise in other areas where smooth muscle is present. As the disease progresses, cancer cells travel through the bloodstream or lymphatic system to form new tumors in distant organs. This spread can lead to complications depending on the organs affected. The disease is characterized by the uncontrolled growth of abnormal cells, which can disrupt normal bodily functions. Symptoms may vary based on the location and size of the tumors.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2022-502975-45-00Protocol codePM1183-C-010-22Estimated enrolment450 patientsSponsorPharma Mar S.A.

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