In January 2020, the LUPER study was submitted to both the AEMPS and the CEIm of the Hospital General Universitario Gregorio Marañón in Madrid, Spain. The LUPER study is a phase I/II, Multicenter, Open-label, Clinical and Pharmacokinetic Study of Lurbinectedin (PM01183) in Combination with Pembrolizumab in Patients with Relapsed Small Cell Lung Cancer (SCLC). Dr. Antonio Calles Blanco, from Gregorio Marañón Hospital, will act as the Principal Investigator, and the initial Phase I will entail the participation of 3 different sites in Madrid (Spain). Overall, LUPER study will recruit around 12 patients on its phase I stage, which will be expanded to 30 additional subjects on the phase II of the study. Enrolment is planned to open in April 2020.
The Phase I stage of the LUPER study is focused on establishing the maximum tolerated dose (MTD) and the recommended phase II dose (RD) of PM01183 in combination with pembrolizumab in patients with relapsed SCLC. On its phase II stage, the primary endpoint of the LUPER study will be to assess the efficacy of the combination in patients with relapsed SCLC, in terms of overall response rate (ORR) according to RECIST 1.1.
For the population with SCLC, initial response to first line (1L) etoposide-platinum doublet chemotherapy is found in up to 80% of SCLC patients; however, disease relapse/progression will ultimately occur in almost all patients. At the time of progression, two therapeutic options are currently accepted: reinduction of etoposide-platinum doublet chemotherapy or, for patients unfit for reinduction or with a short duration of 1L response, single-agent topotecan or anthracycline-containing regimens. In both cases, unfortunately, median survival is seldom longer than several weeks, with long-term survivorship being extremely rare.
At MedSIR we believe that the LUPER study represents a great opportunity for a target population with very poor prognosis, significant morbidity and mortality, and where few treatment options currently exist. We would like to thank all the study investigators for their interest in participating in this trial.