LUPER

OFFICIAL TITLE: 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 (THE LUPER STUDY). 

PROJECT DETAILS

THIS IS A PROSPECTIVE, OPEN-LABEL, UNCONTROLLED CLINICAL TRIAL. THE STUDY WILL BE DIVIDED INTO TWO STAGES: A DOSE-RANGING PHASE I STAGE WITH ESCALATING DOSES OF PM01183 IN COMBINATION WITH A FIXED DOSE OF PEMBROLIZUMAB, FOLLOWED BY A NON-RANDOMIZED PHASE II STAGE AS AN EXPANSION STUDY AT THE RECOMMENDED DOSE (RD) DETERMINED DURING THE PHASE I STAGE.
PRIMARY GOAL DURING THE PHASE I STAGE IS TO DETERMINE THE MTD AND RECOMMENDED PHASE II DOSE (RD) OF LURBINECTEDIN (PM01183) IN COMBINATION WITH PEMBROLIZUMAB IN PATIENTS WITH RELAPSED SCLC. THEREFORE, DURING THE PHASE II, THE MAIN GOAL IS TO ASSESS THE EFFICACY OF LURBINECTEDIN (PM01183) IN COMBINATION WITH PEMBROLIZUMAB IN TERMS OF ORR, ACCORDING TO RECIST 1.1, IN PATIENTS WITH RELAPSED SCLC.

LUPER AT CLINICALTRIALS.GOV

TUMOR TYPE

PHASE

SCLC

I/II

12  Phase I

30 Phase II

3

Spain

N

SITES

COUNTRY

STATUS

Start-up

LUPER SITES

SPAIN

Hospital Universitario Gregorio Marañón 

SPAIN

Centro Integral Oncologico Clara Campal-HM Norte Sanchinarro

SPAIN

Fundación Jiménez Díaz