LUPER

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.