Authorised Therapeutic confirmatory (Phase III) Metastatic leiomyosarcoma

Public Title: Study of Lurbinectedin in Combination with Doxorubicin versus Doxorubicin Alone as First-line Treatment in Participants with Metastatic Leiomyosarcoma

EU CTIS ID: 2022-502975-45-00

What this study is testing

The primary objective of this III study is to evaluate whether the combination of lurbinectedin plus doxorubicin given as first line treatment for metastatic leiomyosarcoma (LMS) prolongs the progression-free survival (PFS) by Independent Review Committee(IRC) when compared to doxorubicin administered as a single agent.

Therapeutic confirmatory (Phase III)

A plain-language read of the study's public EU CTIS listing. The study team confirms the details.

Who can take part

You may be able to join if

1. Voluntary signed and dated written informed consent of the patient, obtained before any study-specific procedure.
2. Age ≥ 18 years.
3. Histologically confirmed diagnosis of metastatic LMS, in patients not candidates for curative resection.
4. Radiologically measurable disease according to the 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 is allowed. Prior line/s of hormone therapy in the adjuvant/metastatic setting are also allowed.
6. Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤ 1.

You likely can't join if

1. Prior treatment with anthracyclines, lurbinectedin or trabectedin.
9. Limitation of the patient’s ability to comply with the treatment or to follow-up the protocol.
11. Patients in whom rapid tumor shrinkage is needed (e.g., when a tumor is close to a critical structure).
10. Women who are pregnant or breast feeding and fertile patients (men and women) who are not using a highly effective method of contraception.* * Women of childbearing potential (WOCBP) must agree to use a highly effective contraception method to avoid pregnancy during the course of the trial (and for at least seven months after the last infusion). Fertile male patients must agree to refrain from fathering a child or donating sperm during the trial and for four months after the last infusion. Valid methods to determine childbearing potential, adequate contraception and requirements of WOCBP partners are described in APPENDIX 2.
2. Known low grade leiomyosarcoma (i.e., grade I).
3. Known hypersensitivity to any of the components of the i.v. formulation of lurbinectedin or doxorubicin.

See the full eligibility criteria

Who can join

1. Voluntary signed and dated written informed consent of the patient, obtained before any study-specific procedure.
2. Age ≥ 18 years.
3. Histologically confirmed diagnosis of metastatic LMS, in patients not candidates for curative resection.
4. Radiologically measurable disease according to the 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 is allowed. Prior line/s of hormone therapy in the adjuvant/metastatic setting are also allowed.
6. Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤ 1.
7. Adequate hematological, renal, metabolic and hepatic function: a) Hemoglobin ≥ 9.0 g/dL [patients may have received prior red blood cell (RBC) transfusion]; absolute neutrophil count (ANC) ≥ 2.0 x 109/L, and platelet count ≥ 100 x 109/L. b) Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3.0 x upper limit of normal (ULN). c) Total bilirubin ≤ 1.5 x ULN or direct bilirubin ≤ ULN if total bilirubin is > ULN. d) Albumin ≥ 3.0 g/dL. e) Calculated creatinine clearance (CrCL) ≥ 30 mL/min (using Cockcroft and Gault’s formula). f) Left ventricular ejection fraction (LVEF) > 50% assessed by multiple-gated acquisition scan (MUGA), echocardiography (ECHO) or cardiac magnetic resonance imaging (MRI).
8. Wash-out periods: a) At least three weeks since last prior systemic treatment. b) At least three weeks since last prior major surgery and one week since last prior minor surgery (port placement is excluded from this wash-out period). c) At least two weeks since last prior radiotherapy.
9. Evidence of non-childbearing status for women of childbearing potential (WOCBP). WOCBP must agree to use a highly effective contraceptive measure up to seven months after treatment discontinuation. Valid methods to determine the childbearing potential, adequate contraception and requirements for WOCBP partners are described in APPENDIX 2. Fertile male patients with WOCBP partners should use condoms during treatment and for four months following the last investigational medicinal product (IMP) dose.

What rules you out

1. Prior treatment with anthracyclines, lurbinectedin or trabectedin.
9. Limitation of the patient’s ability to comply with the treatment or to follow-up the protocol.
11. Patients in whom rapid tumor shrinkage is needed (e.g., when a tumor is close to a critical structure).
10. Women who are pregnant or breast feeding and fertile patients (men and women) who are not using a highly effective method of contraception.* * Women of childbearing potential (WOCBP) must agree to use a highly effective contraception method to avoid pregnancy during the course of the trial (and for at least seven months after the last infusion). Fertile male patients must agree to refrain from fathering a child or donating sperm during the trial and for four months after the last infusion. Valid methods to determine childbearing potential, adequate contraception and requirements of WOCBP partners are described in APPENDIX 2.
2. Known low grade leiomyosarcoma (i.e., grade I).
3. Known hypersensitivity to any of the components of the i.v. formulation of lurbinectedin or doxorubicin.
4. Concomitant diseases/conditions: a) History of cardiac disease: myocardial infarction or angina within the last year prior to enrollment; severe valvular disease; or symptomatic arrhythmia despite ongoing treatment. b) Patients with any immunodeficiency, including those known to be infected by human immunodeficiency virus (HIV). c) Known chronic active hepatitis or cirrhosis. For Hepatitis B, this includes positive tests for both Hepatitis B surface antigen and quantitative Hepatitis B polymerase chain reaction (PCR). For Hepatitis C, this includes positive tests for both Hepatitis C antibody and quantitative Hepatitis C PCR. d) Active uncontrolled infection. e) Any other major illness (including severe cardiovascular disease) or risk factors that, in the Investigator’s judgment, will substantially increase the risk associated with the patient’s participation in this study.
5. Use of strong inducers of CYP3A activity within two weeks prior to the first infusion of lurbinectedin.
6. Prior irradiation of a RECIST v.1.1 target lesion if only one target lesion is available, unless progression of this lesion has been confirmed.
7. Known myopathy (history of resolved steroid-induced myopathy is allowed).
8. History of malignancies other than LMS within 3 years prior to enrollment, except for malignancies with a negligible risk of metastasis or death (e.g., 5-year OS rate > 90%), such as adequately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, localized prostate cancer, non-muscle-invasive urothelial carcinomas, ductal carcinoma in situ, or stage I uterine cancer. Prior malignancies should have received curative treatment and should remain in remission. The Investigator should ensure, based on histology and/or clinical information, that the current metastatic sites are leiomyosarcoma and not recurrence of the original malignancy.

The study team makes the final eligibility decision.

Where it's taking place

Switzerland
United States
United Kingdom

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include Switzerland; United States; United Kingdom. Enter your location above to see the nearest site and check your eligibility.

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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.