Spots Global Cancer Trial Database for Safety and Efficacy Study of GEN1046 as a Single Agent or in Combination With Pembrolizumab for Treatment of Recurrent (Non-small Cell) Lung Cancer
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Trial Identification
Brief Title: Safety and Efficacy Study of GEN1046 as a Single Agent or in Combination With Pembrolizumab for Treatment of Recurrent (Non-small Cell) Lung Cancer
Official Title: A Phase 2, Multicenter, Randomized, Open-Label Trial of GEN1046 as Monotherapy and in Combination Pembrolizumab Therapy in Subjects With Relapsed/Refractory Metastatic Non-Small Cell Lung Cancer After Treatment With Standard of Care Therapy With an Immune Checkpoint Inhibitor
Study ID: NCT05117242
Conditions
Study Description
Brief Summary: The purpose of this trial is to investigate the safety and efficacy of acasunlimab (also known as GEN1046) as monotherapy and in combination with pembrolizumab in patients with non-small cell lung cancer who have progressed during or after treatment of previous standard of care
Detailed Description: This trial is a randomized, open-label trial evaluating the safety and efficacy of acasunlimab (GEN1046) as monotherapy and in combination therapy with pembrolizumab. The trial consists of two parts; a safety phase and an extension phase. The extension phase will be initiated once the safety phase is completed.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
St. Joseph Heritage Healthcare, Santa Rosa, California, United States
Florida Cancer Specialists - FCS South, Fort Myers, Florida, United States
Florida Cancer Center, Saint Petersburg, Florida, United States
Henry Ford Cancer Institute, Detroit, Michigan, United States
Cancer & Hematology Centers of Western Michigan CHCWM P.C., Grand Rapids, Michigan, United States
Oncology Clinical Trials Ascension Providence Hospital, Southfield, Michigan, United States
Penn State Cancer Institute Penn State Health Herhsey Medical Center, Hershey, Pennsylvania, United States
Medical College of Wisconsin, Milwaukee, Wisconsin, United States
Institut Bergonie, Bordeaux, , France
Hopital Morvan CHU de Brest, Brest, , France
Hopital Charles Nicolle Chu Rouen, Rouen, , France
Hopital dInstruction Des Armees Begin, St Mande, , France
Institut de Cancerologie Strasbourg Europe (ICANS), Strasbourg, , France
Hôpital Foch, Suresnes, , France
Gustave Roussy, Villejuif, , France
IKF Krankenhaus Nordwest, Frankfurt am main, , Germany
Med.Hochschule Hannover Klinik für Pneumologie, Hanover, , Germany
Universitatsklinik Giessen und Marburg Standort Giessen, Hessen, , Germany
LKI Lungenfachklinik Immenhausen, Immenhausen, , Germany
Department of Internal Medicine II, Regensburg, , Germany
Azienda Ospedaliera Universitaria Policlinico G Rodolico San Marco, Catania, , Italy
ASL 3 Genovese Ospedale Villa Scassi, Genova, , Italy
IRCCS Istituto Europeo di Oncologia, Milano, , Italy
UOC Oncoematologia AOU L.Vanvitelli, Napoli, , Italy
La Maddalena SPA, Palermo, , Italy
AUSL della Romagna, Ravenna, , Italy
IFO Regina Elena, Roma, , Italy
Netherlands Cancer Institute, Amsterdam, , Netherlands
VU University Medical Center, Amsterdam, , Netherlands
Leids Universitair Medisch Centrum, Leiden, , Netherlands
Erasmus MC, Rotterdam, , Netherlands
Samodzielny Publiczny Zespol Gruzlicy i Chorob Pluc, Olsztyn, , Poland
Med Polonia Sp. z o.o., Poznań, , Poland
Szpital Specjalistyczny w Prabutach Sp. z o.o., Prabuty, , Poland
Maria Sklodowska-Curie National Research Institute of Oncology, Warszawa, , Poland
Clinical Academic Center Braga, Braga, , Portugal
Centro Clinico Champalimaud, Lisbon, , Portugal
Instituto Portugues de Oncologio de Lisboa, Lisbon, , Portugal
Centro Hospitalar Universitário do Porto - Hospital de Santo Antonio, Porto, , Portugal
Hospital Universitari Vall dHebron, Barcelona, , Spain
Clinica Universidad de Navarra CUN, Madrid, , Spain
Hospital Universitario 12 de Octubre, Madrid, , Spain
Hospital Universitario Fundacion Jimenez Diaz, Madrid, , Spain
MD Anderson Cancer Center, Madrid, , Spain
Hospital Universitario Virgen de la Victoria, Málaga, , Spain
Clinica Universidad de Navarra, Pamplona, , Spain
Fundacion Instituto Valenciano de Oncologia, Valencia, , Spain
Hospital Clinico Universitario de Valencia, Valencia, , Spain
Cheltenham General Hospital, Cheltenham, , United Kingdom
King's College London, Guy's Hospital, London, , United Kingdom
University College London, London, , United Kingdom
The Christie Hospital, Manchester, , United Kingdom
Contact Details
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