PM1183-C-010-22
Research type
Research Study
Full title
Randomized, Controlled, Open-label, Phase IIb/III Study of Lurbinectedin in Combination with Doxorubicin versus Doxorubicin Alone as First-line Treatment in Patients with Metastatic Leiomyosarcoma
IRAS ID
1007801
Contact name
Luis Mora
Contact email
Sponsor organisation
Pharma Mar S.A.
Eudract number
2022-502975-45
Research summary
Leiomyosarcoma (LMS) is a type of rare cancer that grows in the smooth muscle tissue. The prognosis for patients with metastatic LMS (cancer that has spread to other parts of the body) is poor, and there are a few effective treatments available.
In previous clinical studies, LMS patients were treated with lurbinectedin in combination with doxorubicin. Lurbinectedin is an experimental medication, that has been shown to kill cancer cells and block tumour growth. Doxorubicin is an approved anti-tumour medication that kills or stops the growth of cancer cells. These studies have shown that treatment with lurbinectedin plus doxorubicin showed benefits in LMS patients, including a reduction in tumour size and/or no worsening of disease.
Therefore, the hypothesis is that lurbinectedin plus with doxorubicin is more effective than doxorubicin alone for the treatment of metastatic LMS in patients when given as a first-line therapy.
The purpose of this study is to test the effectiveness and safety of this treatment combination compared to doxorubicin alone. The study is split into Phase II b and Phase III. The aim is to find the ideal dosing regimen of the study medications, and to test them in a larger number of patients. The study will last approximately 40 months, and around 240 participants will take part.
Only patients that have not received previous systemic therapy for their cancer are eligible to participate.
The study includes a Screening, Treatment and Follow-up period lasting in total approximately 15 months for each participant. In the treatment period, participants will either receive lurbinectedin in combination with doxorubicin or doxorubicin alone, once every 3 weeks. Treatment will be administered intravenously on Day 1 of each cycle at study site. At the end of the treatment period, participants will complete an end of study visit. Participants of this research study will also be invited to a pharmacogenomic sub-study detailed on page 81 of the protocol.REC name
Yorkshire & The Humber - Leeds East Research Ethics Committee
REC reference
23/YH/0176
Date of REC Opinion
16 Oct 2023
REC opinion
Further Information Favourable Opinion