Spots Global Cancer Trial Database for A Study of Pralsetinib Versus Standard of Care for First-Line Treatment of Advanced Non-Small Cell Lung Cancer (NSCLC)
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Trial Identification
Brief Title: A Study of Pralsetinib Versus Standard of Care for First-Line Treatment of Advanced Non-Small Cell Lung Cancer (NSCLC)
Official Title: A Phase III, Randomized, Open-Label Study of Pralsetinib Versus Standard of Care for First-Line Treatment of RET Fusion-Positive, Metastatic Non-Small Cell Lung Cancer
Study ID: NCT04222972
Conditions
Study Description
Brief Summary: This is an international, randomized, open-label, Phase 3 study designed to evaluate whether the potent and selective RET inhibitor, pralsetinib, improves outcomes when compared to a platinum chemotherapy-based regimen chosen by the Investigator from a list of standard of care treatments, as measured primarily by progression free survival (PFS), for participants with RET fusion-positive metastatic NSCLC who have not previously received systemic anticancer therapy for metastatic disease.
Detailed Description:
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
UC Irvine Medical Center, Orange, California, United States
Southern California Kaiser Permanente, San Diego, California, United States
Hospital Britanico; Oncologia, Buenos Aires, , Argentina
Centro Oncologico Korben; Oncology, Ciudad Autonoma Buenos Aires, , Argentina
Centro Oncologico Riojano Integral (CORI), La Rioja, , Argentina
Royal North Shore Hospital; Department of Medical Oncology, St Leonards, New South Wales, Australia
Flinders Medical Centre, Bedford Park, South Australia, Australia
UZ Antwerpen, Edegem, , Belgium
Liga Norte Riograndense Contra O Câncer, Natal, RN, Brazil
Oncosite - Centro de Pesquisa Clinica Em Oncologia Ltda, Ijui, RS, Brazil
Hospital Sao Lucas - PUCRS, Porto Alegre, RS, Brazil
Instituto do Cancer do Estado de Sao Paulo - ICESP, Sao Paulo, SP, Brazil
Hospital A. C. Camargo; Oncologia, Sao Paulo, SP, Brazil
Clinica CIMCA, San José, , Costa Rica
Institut Bergonie CLCC Bordeaux, Bordeaux, , France
Hôpital Ambroise Paré - Boulogne-Billancourt, Boulogne Billancourt, , France
Hôpital Louis Pradel, Hospices Civils de Lyon, Bron, , France
CHRU Lille Service de Pneumologie et Oncologie Thoracique, Lille, , France
Institut Paoli Calmettes; Oncologie Medicale, Marseille, , France
Hopital Bichat Claude Bernard; Oncologie Serv., Paris, , France
Hopital Tenon;Pneumologie, Paris, , France
Hopital de Pontchaillou; Service de Pneumologie, Rennes, , France
Ico Rene Gauducheau; Oncologie, Saint Herblain, , France
CHU Strasbourg - Nouvel Hopital Civil, Strasbourg, , France
CHU de Toulouse - Hôpital Larrey; Service de pneumologie et oncologie pneumologique, Toulouse cedex 9, , France
Institut Gustave Roussy; Departement Oncologie Medicale, Villejuif, , France
Universitätsklinikum Carl Gustav Carus, Medizinische Klinik I, Pneumologie MK1-A13, Dresden, , Germany
Asklepios-Fachkliniken Muenchen-Gauting; Onkologie, Gauting, , Germany
Pius-Hospital; Klinik fuer Haematologie und Onkologie, Oldenburg, , Germany
Leopoldina-Krankenhaus Medizinische Klinik II, Schweinfurt, , Germany
Klinik Schillerhöhe; Pneumologische Onkologie, Stuttgart, , Germany
St. James Hospital; Oncology, Dublin, , Ireland
Ospedale Clinicizzato SS Annunziata, Chieti, Abruzzo, Italy
Istituto Nazionale per lo Studio e la Cura dei Tumori Fondazione G. Pascale, Napoli, Campania, Italy
Ospedale Provinciale Santa Maria Delle Croci; Oncologia Medica, Ravenna, Emilia-Romagna, Italy
Istituto Nazionale Tumori Regina Elena, Roma, Lazio, Italy
AZ. Ospedaliera San Giovanni - Addolorata, Roma, Lazio, Italy
Irccs Ospedale San Raffaele, Milano, Lombardia, Italy
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano, Lombardia, Italy
Istituto Europeo Di Oncologia, Milano, Lombardia, Italy
IRCCS Giovanni Paolo II Istituto Oncologico, Bari, Puglia, Italy
Azienda Ospedaliera Universitaria Pisana - Ospedale Cisanello; Dipartimento Cardio Toraco Vascolare, Pisa, Toscana, Italy
IOV - Istituto Oncologico Veneto - IRCCS; Oncologia Medica II, Padova, Veneto, Italy
A.O.U. INTEGRATA DI VERONA-Ospedale Civile Maggiore Borgo Trento; U.O.C. Oncologia, Verona, Veneto, Italy
Nagoya University Hospital, Aichi, , Japan
Hirosaki University Hospital, Aomori, , Japan
Ehime University Hospital, Ehime, , Japan
Kyushu University Hospital, Fukuoka, , Japan
National Hospital Organization Himeji Medical Center, Hyogo, , Japan
Kanagawa Cancer Center, Kanagawa, , Japan
Osaka City General Hospital, Osaka, , Japan
Osaka International Cancer Institute, Osaka, , Japan
Kansai Medical University Hospital, Osaka, , Japan
Juntendo University Hospital, Tokyo, , Japan
The Cancer Institute Hospital of JFCR, Tokyo, , Japan
National Hospital Organization Yamaguchi - Ube Medical Center, Yamaguchi, , Japan
National Cancer Center, Goyang-si, , Korea, Republic of
Seoul National University Hospital, Seoul, , Korea, Republic of
Severance Hospital, Yonsei University Health System, Seoul, , Korea, Republic of
Asan Medical Center, Seoul, , Korea, Republic of
Health Pharma Professional Research, Cdmx, Mexico CITY (federal District), Mexico
NKI/AvL, Amsterdam, , Netherlands
Universitair Medisch Centrum Groningen, Groningen, , Netherlands
Maastricht University Medical Center, Maastricht, , Netherlands
Oslo universitetssykehus HF, Ullevål, Kreftsenteret, Oslo, , Norway
Hemato Oncología de Panamá Especializada, Panama City, , Panama
Narod.Inst.Onkol. im. M.Sklodowskiej - Curie-Panst.Inst.Bad; Klinika Nowot.Pluca i Klatki Piers, Warszawa, , Poland
Hospital Garcia de Orta; Servico de Pneumologia, Almada, , Portugal
IPO do Porto; Servico de Oncologia Medica, Porto, , Portugal
Centro Hospitalar de Vila Nova de Gaia / Espinho E.P.E, Vila Nova de Gaia, , Portugal
Hospital Univ. Central de Asturias; Servicio de Oncologia, Oviedo, Asturias, Spain
Hospital Universitario Germans Trias i Pujol, Badalona, Barcelona, Spain
Insititut Catala D'Oncologia, Hospitalet de Llobregat, Barcelona, Spain
Hospital Universitario Marques de Valdecilla; Servicio de Oncologia, Santander, Cantabria, Spain
Complejo Hospitalario Universitario A Coruña, A Coruña, LA Coruña, Spain
Hospital Universitari Vall d'Hebron, Barcelona, , Spain
Hospital Clínic. Barcelona, Barcelona, , Spain
Hospital General Universitario Gregorio Marañon; Servicio de Oncologia, Madrid, , Spain
Hospital Ramon y Cajal; Servicio de Oncologia, Madrid, , Spain
HOSPITAL DE MADRID NORTE SANCHINARRO- CENTRO INTEGRAL ONCOLOGICO CLARA CAMPAL; Servicio de Oncologia, Madrid, , Spain
Hospital Regional Universitario de Malaga, Malaga, , Spain
Hospital Universitario Virgen del Rocio; Servicio de Oncologia, Sevilla, , Spain
Hospital General Universitario de Valencia; Servicio de oncologia, Valencia, , Spain
Hosp Clinico Univ Lozano Blesa; División De Oncología Médica, Zaragoza, , Spain
Karolinska Universitetssjukhuset, Solna; Kliniska prövningsenheten Z:4:01, Stockholm, , Sweden
UniversitätsSpital Zürich; Zentrum für Hämatologie und Onkologie, Klinik für Onkologie, Zürich, , Switzerland
Adana City Hospital, Medical Oncology, Adana, , Turkey
Adana Baskent University Hospital; Medical Oncology, Adana, , Turkey
Ankara Bilkent City Hospital, Ankara, , Turkey
Medipol Mega Üniversite Hastanesi Göztepe, Istanbul, , Turkey
?zmir Medical Point; Oncology, Kar?iyaka, , Turkey
Medical Park Seyhan Hospital; Oncology Department, Seyhan, , Turkey
Velindre Cancer Centre; Oncology Dept, Cardiff, , United Kingdom
Leicester Royal Infirmary; Dept. of Medical Oncology, Leicester, , United Kingdom
University College Hospital; Department of Oncology, London, , United Kingdom
Guys & St Thomas Hospital; Department of Oncology, London, , United Kingdom
Royal Marsden Hospital; Dept of Med-Onc, London, , United Kingdom
Christie Hospital Nhs Trust; Medical Oncology, Manchester, , United Kingdom
Royal Marsden Hospital; Dept of Medical Oncology, Sutton, , United Kingdom
Contact Details
Name: Clinical Trials
Affiliation: Hoffmann-La Roche
Role: STUDY_DIRECTOR
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