Lurbinectedin + doxorubicin as first-line treatment in metastatic leiomyosarcoma (SaLuDo)
Lurbinectedin + Doxorubicin vs. Doxorubicin alone as first-line treatment in metastatic leiomyosarcomas
| Agents: | Lurbinectedin & Doxorubicin |
| Phase | IIb / III |
| Status | Recruiting |
| Sponsor | PharmaMar |
For further information please also consult ClinicalTrials.gov.
This IIb/III study evaluates whether the combination of lurbinectedin plus doxorubicin given as first line treatment for metastatic leiomyosarcoma (LMS) prolongs the progression-free survival (PFS) compared to doxorubicin alone
WHO is the trial for? |
Excluded are grade 1 LMS |
WHAT is the key question that this trial is attempting to answer? |
This trial assesses if the combination of lurbinectedin plus doxorubicin given as first line treatment for metastatic leiomyosarcoma can prolong the progression-free survival (PFS) compared to doxorubicin alone. |
WHY patients might want to participate? |
By participating in this study, individuals have the opportunity to contribute to advancing our understanding of more effective treatment options for metastatic leiomyosarcoma, potentially leading to improved outcomes and a positive impact on patient care and progression-free survival. |
WHEN will the trial be open? |
This study is open for recruitment. |
WHERE is the trial available? |
The trial is currently being conducted in France, Italy, Spain and the US, futher sites will be opening soon. For further information please check here. |
STUDY DESIGN: What does the study look like? |
This study is comparing the efficacy of the combination of lurbinectedin + doxorubicin versus doxorubicin alone in metastatic leiomyosarcoma patients. There are two parts of the study: Phase IIb and phase III. Phase IIb needs to be completed before phase III can start.
In Phase IIb, the trial has three study arms: all participating patients will be randomly divided (by a computer) in three groups. Group 1 and 2 receive the combination of lurbinectedin + doxorubicin in different doses, group 3 receives doxorubicin alone in the standard dosage.
Phase IIb will determine the optimal dosage for the combination of lurbinectedin + doxorubicin. In Phase III, there will only be 2 study arms: Group 1 with the optimal dosage of lurbinectedin + doxorubicin, as determined in phase IIb. Group 2 receives doxorubicin alone. Participants will receive doxorubicin intravenously every three weeks on day 1 of each treatment cycle (treatment cycle = three weeks), the combination is intravenously every three weeks (q3wk) on day 1 of each treatment cycle (treatment cycle = three weeks).
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HOW do I get more information? |
ClinicalTrials.gov, cancer societies or specific cancer-focused patient advocacy groups in your country may offer additional information about the trial, current recruitment status, and key contacts. Click here for a list of patient organizations that might be helpful. If there are no such organization in your country, please email us for more information: info@sarcoma-patients.org |
Disclaimer: This is a patient-friendly summary of the clinical trial which has been provided for informational purposes only. Patients should consult their physician about any clinical trial opportunity.