EORTC-1825-LCG

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Activity of Lorlatinib based on ALK resistance mutations on blood in ALK positive NSCLC patients previously treated with 2nd generation ALK inhibitor

Study documentation

Trial Status	Closed to Patient Entry
Dates	Date of activation: 17-Nov-2020 Date Step1 close: 01-Jul-2023 Date Step2 close: 07-Jul-2023
Data management at EORTC	Yes
Design	Phase 2 Randomized open label
Targeted Sample size	All Groups: 100
Treatment	Drug Lorlatinib
Study Staff	Anne-Marie Dingemans (Study Coordinator) , Erasmus MC, Rotterdam Hadi Almidani (Pharmacovigilance Manager) , EORTC Headquarters, Brussels Luc Boone (Statistical Fellow) , EORTC Headquarters, Brussels Jose Casas (TR Scientist) , EORTC Headquarters, Brussels Corinne Daumer (Project Manager) , EORTC Headquarters, Brussels Shani De Coster (Data Manager) , EORTC Headquarters, Brussels Terry Desmae (TR Manager) , EORTC Headquarters, Brussels Beatrice Fournier (Clinical Scientist) , EORTC Headquarters, Brussels Amaya Gonzalez (Clinical Research Associate/Monitor) , EORTC Headquarters, Brussels Anne-Sophie Govaerts (Clinical Scientist) , EORTC Headquarters, Brussels Lore Hermans (Regulatory Affairs Manager) , EORTC Headquarters, Brussels Laura Mezquita (Y-ECI Coordinator) , Hospital Clinic de Barcelona, Barcelona Ana Teresa Mota (Data Manager) , EORTC Headquarters, Brussels Maya Persoons (Data Manager) , EORTC Headquarters, Brussels Miguel Remis (Lead CRA) , EORTC Headquarters, Brussels Sandrine Rivrain (Pharmacovigilance Manager) , EORTC Headquarters, Brussels Natalia Rueda (Clinical Research Physician) , EORTC Headquarters, Brussels Maarten Spruyt (Imaging DM) , EORTC Headquarters, Brussels Eliza Starczewska (Regulatory Affairs Administrator) , EORTC Headquarters, Brussels Carla Sureda (Clinical Operations Manager) , EORTC Headquarters, Brussels Tim Verbiest (Study Designer) , EORTC Headquarters, Brussels Yuliya Vostrikova (Clinical Data Expert) , EORTC Headquarters, Brussels Leen Wijnen (Imaging DM) , EORTC Headquarters, Brussels Eleni Xenophontos (Clinical Research Physician) , EORTC Headquarters, Brussels
Type of cancer	Lung
Participating groups	EORTC Lung Cancer Group
Recruiting centers	APHP Hop Univ Paris Seine-Saint-Denis- Hop Avicenne (Bobigny, France) Academisch Ziekenhuis Maastricht (Maastricht, Netherlands) CHU Mont Godinne - UCL Namur (Yvoir, Belgium) CHU de Brest (Brest, France) Centre Hopitalier Intercommunal De Creteil (Creteil, France) Centre Hospitalier Avignon (AVIGNON CEDEX 9, France) Clinica Universidad de Navarra-Site Madrid (Madrid, Spain) Clinica Universitaria De Navarra (Pamplona, Spain) Cliniques Universitaires Saint-Luc (Brussels, Belgium) Cliniques Universitaires Saint-Luc (Brussels, Belgium) Erasmus MC (Rotterdam, Netherlands) Gustave Roussy (VILLEJUIF CEDEX, France) Hospital Clinic de Barcelona (Barcelona, Spain) Hospital De La Santa Creu I Sant Pau (Barcelona, Spain) Hospital De La Santa Creu I Sant Pau (Barcelona, Spain) Hospital General Universitario Gregorio Maranon (Madrid, Spain) Hospital Universitari Son Espases (Palma De Mallorca, Spain) Hospital Universitario 12 De Octubre (Madrid, Spain) Hospital Universitario Ramon y Cajal (Madrid, Spain) ICO Badalona - Hospital Germans Trias i Pujol (Institut Catala D'Oncologia) (Badalona - (Barcelona), Spain) ICO L’Hospitalet - Hospital Duran i Reynals (Institut Catala D'Oncologia) (L' Hospitalet De Llobregat, Spain) Institut Jules Bordet (Anderlecht, Belgium) King Hussein Cancer Center (Amman, Jordan) Oslo University Hospital - Radiumhospitalet (Oslo, Norway) The Christie NHS Foundation Trust (Manchester, United Kingdom) The Netherlands Cancer Institute-Antoni Van Leeuwenhoekziekenhuis (Amsterdam, Netherlands) Universitair Ziekenhuis Antwerpen (Edegem, Belgium) Universitair Ziekenhuis Antwerpen (Edegem, Belgium) University Hospital Virgen del Rocio (Sevilla, Spain)
Protocol summary	http://clinicaltrials.gov/study/NCT04127110
NCT number	NCT04127110
EudraCT	2019-003862-41
Financial Support	Educational Grant