Clinical Trial Details
EORTC-1613-LCG
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APPLE trial:Feasibility and activity of AZD9291(osimertinib) treatment on Positive PLasma T790M in EGFR mutant NSCLC patients
| Trial Status | Closed to Patient Entry |
|---|---|
| Dates |
Date of activation: 06-Oct-2017 Date Step1 close: 12-Feb-2020 Date Step2 close: 12-Feb-2020 |
| Data management at EORTC | Yes |
| Design |
Phase 2 Randomized open label |
| Targeted Sample size | All Groups: 154 |
| Treatment |
Drug Gefitinib, Osimertinib |
| Study Staff |
Rafal Dziadziuszko (Study Coordinator) , Medical University Of Gdansk , Gdansk Hadi Almidani (Pharmacovigilance Manager) , EORTC Headquarters, Brussels Beatrice Fournier (Clinical Scientist) , EORTC Headquarters, Brussels Amaya Gonzalez (Clinical Research Associate/Monitor) , EORTC Headquarters, Brussels Fanny Grillet (TR Scientist) , EORTC Headquarters, Brussels Selin Gundogan (Clinical Operations Manager) , EORTC Headquarters, Brussels Juliette Ly (Project Manager) , EORTC Headquarters, Brussels Davide Passariello (Project Manager) , EORTC Headquarters, Brussels Jordi Remon Masip (Y-ECI Coordinator) , Gustave Roussy, VILLEJUIF CEDEX Sandrine Rivrain (Pharmacovigilance Manager) , EORTC Headquarters, Brussels Katheline Vander Heggen (Regulatory Affairs Manager) , EORTC Headquarters, Brussels Tim Verbiest (Data Manager) , EORTC Headquarters, Brussels Yuliya Vostrikova (Clinical Data Expert) , EORTC Headquarters, Brussels Leen Wijnen (Imaging DM) , EORTC Headquarters, Brussels Xiao Mang Zhou (Junior RAM) , EORTC Headquarters, Brussels |
| Type of cancer | Lung |
| Participating groups | EORTC Lung Cancer Group |
| Recruiting centers |
CHU de Brest (Brest, France) CHU de Toulouse - Hopital Larrey (TOULOUSE CEDEX 9, France) Centre Francois Baclesse (CLCC) (CAEN CEDEX 5, France) Centre Hopitalier Intercommunal De Creteil (Creteil, France) Consorci Sanitri Del Maresme -ICO Badalona - Hospital De Mataro (Mataro (Barcelona), Spain) Gustave Roussy (VILLEJUIF CEDEX, France) Hopital Nord (APHM) (Marseille, France) Hospital Clinic de Barcelona (Barcelona, Spain) Hospital De La Santa Creu I Sant Pau (Barcelona, Spain) Hospital Universitari Vall d’Hebron -Vall d'Hebron Institut Oncologia (Barcelona, Spain) Hospital Universitario 12 De Octubre (Madrid, Spain) Hospital Universitario Ramon y Cajal (Madrid, Spain) Institut Bergonie (Bordeaux, France) Institut Jules Bordet (Anderlecht, Belgium) Institut Paoli-Calmettes (MARSEILLE CEDEX 09, France) King Hussein Cancer Center (Amman, Jordan) Medical University Of Gdansk (Gdansk, Poland) The Institute Of Oncology (Ljubljana, Slovenia) University Clinic Golnik (Golnik, Slovenia) University Hospital A Coruna-Hospital Teresa Herrera (A Coruna, Spain) University Hospital Virgen del Rocio (Sevilla, Spain) |
| Protocol summary | http://clinicaltrials.gov/study/NCT02856893 |
| NCT number | NCT02856893 |
| EudraCT | 2016-001834-82 |
| Financial Support | Educational Grant |
