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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).
PRESS RELEASE
CLINICAL TRIAL 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.
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LUPER AT CLINICALTRIALS.GOV
TUMOR TYPE
PHASE
SCLC
I/II
13 Phase I
28 Phase II
3
Spain
N
SITES
COUNTRY
STATUS
Analysis
SCIENTIFIC IMPACT
ESMO 2023 – DOWNLOAD PRESENTATION
ASCO 2022 – DOWNLOAD THE POSTER
Dr. Antonio Calles discusses the pivotal lung cancer LUPER clinical trial at the ESMO 2023 congress in Madrid.
TRIAL RESUME
BLOG ARTICLES RELATED
LUPER SITES
SPAIN
Hospital Universitario Gregorio Marañón
SPAIN
Centro Integral Oncologico Clara Campal-HM Norte Sanchinarro
SPAIN
Fundación Jiménez Díaz
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