We are thrilled to communicate that the Luper study recruitment is underway!
Luper is a Phase I/II, Multicenter, Open-label, Clinical and Pharmacokinetic Study to assess the efficacy of Lurbinectedin (PM01183) in Combination with Pembrolizumab in Patients with Relapsed Small Cell Lung Cancer.
We aim to demonstrate that the combination of PM01183 and pembrolizumab will result in clinical benefit and increase the survival of patients with relapsed SCLC, compared to the standard of care in this setting.
The Luper study includes pharmacokinetics, pharmacogenomics, pharmacogenetics and, several biomarkers analysis. Upon MTD and RD determination (current stage I) additional 30 patients will be included for efficacy assessment in stage II.
Inclusion criteria:
~ Male/female adults with histologically confirmed diagnosis of SCLC whose disease has progressed after first-line chemotherapy-based regimen.
~ ECOG performance status of 0 to 1.
~ Measurable disease according to RECIST 1.1.
Exclusion criteria:
~ Prior exposure to;
a) PM01183
b) Radioimmunoconjugates
c) Biologic therapies
d) Experimental anti-tumor vaccines;
~ Has recently received prior systemic anti-cancer therapy
~ Has recently received prior radiotherapy
The participating sites of the study are:
· Hospital Universitario Gregorio Marañón
· START Madrid-Centro Integral Oncológico Clara Campal – HM Norte Sanchinarro
· Fundación Jimenez Díaz START MADRID
We truly appreciate the entire investigator team’s involvement in the LUPER study and the study team involved in the IMP arrival to sites.
Read here for more information on the LUPER study and contact us if you have a great idea for a clinical trial!
Author: Gemma Martinez
