Clinical Trial Details

EORTC-1417-LCG

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A phase II study of etoposide and cis/carboplatin with or without pembrolizumab in untreated extensive small cell lung cancer

Study documentation

Trial Status Closed to Patient Entry
Dates Date of activation: 22-Nov-2017
Date Step1 close: 24-Sep-2019
Date Step2 close: 24-Sep-2019
Data management at EORTC Yes
Design Phase 2
Randomized open label
Targeted Sample size EORTC Groups: 118 - All Groups: 118
Treatment Drug
Carboplatin, Cisplatin, Etoposide, Pembrolizumab
Study Staff Benjamin Besse (Study Coordinator) , Gustave Roussy, VILLEJUIF CEDEX
Jessica Menis (Study Coordinator) , Azienda Ospedaliera Universitaria Integrata Verona - Ospedale Borgo Roma, Verona
Hadi Almidani (Pharmacovigilance Manager) , EORTC Headquarters, Brussels
Jose Casas (TR Scientist) , EORTC Headquarters, Brussels
Jose Casas (TR Manager) , EORTC Headquarters, Brussels
Beatrice Fournier (Clinical Scientist) , EORTC Headquarters, Brussels
Niels Lema (Study Designer) , EORTC Headquarters, Brussels
Hafida Lmalem (Imaging Officer) , EORTC Headquarters, Brussels
Livia Meirsman (Project Manager) , EORTC Headquarters, Brussels
Ellen Peeters (Senior Clinical Operations Manager) , EORTC Headquarters, Brussels
Sandrine Rivrain (Pharmacovigilance Manager) , EORTC Headquarters, Brussels
Xiao Mang Zhou (Junior RAM) , EORTC Headquarters, Brussels
Type of cancer
Participating groups EORTC Lung Cancer Group
Recruiting centers APHP Hop Univ Paris Seine-Saint-Denis- Hop Avicenne (Bobigny, France)
Azienda Ospedaliera Per L'Emergenza Cannizzaro (Catania, Italy)
Azienda Ospedaliero-Universitaria "Santa Maria della Misericordia" di Udine (Udine, Italy)
Azienda Sociosanitaria Territoriale Santi Paolo E Carlo (Milano, Italy)
CHU de Brest (Brest, France)
CHU de Brest (Brest, France)
Centre Francois Baclesse (CLCC) (CAEN CEDEX 5, France)
Centre Hopitalier Intercommunal De Creteil (Creteil, France)
Centre Hospitalier Avignon (AVIGNON CEDEX 9, France)
Centre Hospitalier D'Annecy Genevois (Pringy, France)
Centre Leon Berard (Lyon, France)
Gustave Roussy (VILLEJUIF CEDEX, France)
Hopital Nord (APHM) (Marseille, France)
Institut de Cancerologie Strasbourg Europe (formar Paul Strauss) (Strasbourg, France)
Istituto Europeo di Oncologia (Milano, Italy)
Santa Croce e Carle General Hospital (Cuneo, Italy)
Sheffield Teaching Hospitals NHS Foundation Trust - Weston Park Hospital (Sheffield, United Kingdom)
The Christie NHS Foundation Trust (Manchester, United Kingdom)
Univ. of Florence -Azienda Ospedaliero-Universitaria Careggi (Firenze, Italy)
Universita Di Torino - Ospedale S. Luigi Gonzaga (Orbassano-Torino, Italy)
Protocol summary http://clinicaltrials.gov/study/NCT02580994
NCT number NCT02580994
EudraCT 2014-003090-42
Financial Support Educational Grant