Spots Global Cancer Trial Database for A Study to Compare the Efficacy and Safety of Entrectinib and Crizotinib in Participants With Advanced or Metastatic ROS1 Non-small Cell Lung Cancer (NSCLC) With and Without Central Nervous System (CNS) Metastases
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Trial Identification
Brief Title: A Study to Compare the Efficacy and Safety of Entrectinib and Crizotinib in Participants With Advanced or Metastatic ROS1 Non-small Cell Lung Cancer (NSCLC) With and Without Central Nervous System (CNS) Metastases
Official Title: Randomized, Open Label, Multicenter, Phase III Study of Entrectinib Versus Crizotinib in Patients With Locally-Advanced or Metastatic Non-Small Cell Lung Cancer Harboring ROS1 Gene Rearrangements With and Without Central Nervous System Metastases
Study ID: NCT04603807
Conditions
Study Description
Brief Summary: The study will compare the efficacy and safety of entrectinib with crizotinib in participants with advanced or metastatic ROS1 non-small cell lung cancer (NSCLC). The participants will self-administer oral entrectinib or crizotinib as described in the protocol and local prescribing information. Treatments will continue until progressive disease, unacceptable toxicity, death, or withdrawal from the study, whichever occurs first.
Detailed Description:
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Hospital Sao Rafael - HSR, Salvador, BA, Brazil
Hospitais Integrados da Gavea S/A, Brasilia, DF, Brazil
Oncoclinicas Rio de Janeiro S.A., Rio de Janeiro, RJ, Brazil
YNOVA Pesquisa Clinica, Florianopolis, SC, Brazil
Hospital de Cancer de Barretos, Barretos, SP, Brazil
Instituto do Cancer do Estado de Sao Paulo - ICESP, Sao Paulo, SP, Brazil
Beijing Union Hospital, Beijing, , China
Jilin Cancer Hospital, Changchun, , China
Hunan Cancer Hospital, Changsha CITY, , China
The Second Xiangya Hospital of Central South University, Changsha, , China
Sichuan Provincial Cancer Hospital, Chengdu, , China
West China Hospital, Sichuan University, Chengdu, , China
The First Affiliated Hospital of Guangzhou Medical University, Guangzhou, , China
Harbin Medical University Cancer Hospital, Harbin, , China
Affiliated Hospital of Jining Medical University, Jining, , China
Nanjing Drum Tower Hospital, the Affiliated Hospital of Nanjing University Medical School, Nanjing City, , China
Guangxi Cancer Hospital of Guangxi Medical University, Nanning City, , China
Shanghai Pulmonary Hospital, Shanghai, , China
Taihe Hospital of Hubei University of Medicine, Shiyan, , China
Union Hospital Tongji Medical College Huazhong University of Science and Technology, Wuhan City, , China
Clinical Hospital Centre Zagreb, Zagreb, , Croatia
Institut Bergonie; Pneumology, Bordeaux, , France
CHRU Lille, Lille, , France
Centre Leon Berard, Lyon, , France
Hopital Nord AP-HM, Marseille, , France
CHU Rennes - Hopital Pontchaillou, Rennes cedex 09, , France
Hopital Larrey; Pneumologie, Toulouse, , France
Hopital Robert Schuman; Pneumologie, Vantoux, , France
HELIOS Klinikum Emil von Behring Klinik f.Pneumologie Onkologie u.Infektiologie, Berlin, , Germany
Uoa Sotiria Hospital; Oncology, Athens, , Greece
Metropolitan Hospital, Athens, , Greece
University Hospital of Larissa;Department of Medical Oncology, Larissa, , Greece
Euromedical General Clinic of Thessaloniki; Oncology Department, Thessaloniki, , Greece
American Oncology Institute, Hyderabad, Andhra Pradesh, India
All India Institute Of Medical Sciences (AIIMS), New Delhi, Delhi, India
MVR Cancer Centre and Research Institute, Kozhikode, Kerala, India
MOC Cancer Care & Research Centre (Unit of Cellcure Cancer Centre Pvt Ltd), Mumbai, Maharashtra, India
MOC Cancer Care & Research Centre, Mumbai, Maharashtra, India
Christian Medical College, Ranipet, Tamil NADU, India
Tata Medical Center; Department of Medical Oncology, Kolkata, WEST Bengal, India
Postgraduate Institute of Medical Education and Research, Chandigarh, , India
Istituto Nazionale per lo Studio e la Cura dei Tumori Fondazione G. Pascale, Napoli, Campania, Italy
IRCCS Istituto Regina Elena (IFO); Oncologia Medica B, Roma, Lazio, Italy
Azienda Ospedaliera San Camillo Forlanini; U.O.C. Pneumologia Ad Indirizzo Oncologico 1, Roma, Lazio, Italy
IRCCS Istituto Nazionale Per La Ricerca Sul Cancro (IST); Oncologia Medica A, Genova, Liguria, Italy
Irccs Istituto Europeo di Oncologia (IEO); Divisione di Oncologia, Milano, Lombardia, Italy
Asst Grande Ospedale Metropolitano Niguarda; Dipartimento Di Ematologia Ed Oncologia, Milano, Lombardia, Italy
ASST DI MONZA; Oncologia Medica, Monza, Lombardia, Italy
Azienda Sanitaria Ospedaliera S Luigi Gonzaga; SSD Oncologia Polomonare (II PAD. IV PIANO), Orbassano, Piemonte, Italy
Azienda Ospedaliera Universitaria Pisana - Ospedale Cisanello; Dipartimento Cardio Toraco Vascolare, Pisa, Toscana, Italy
IRCCS Istituto Oncologico Veneto (IOV); Oncologia Medica Seconda, Padova, Veneto, Italy
King Hussein Cancer Center, Amman, , Jordan
Hotel Dieu de France, Beirut, , Lebanon
Hospital Civil de Guadalajara Fray Antonio Alcalde, Guadalajara, Jalisco, Mexico
Health Pharma Professional Research, Cdmx, Mexico CITY (federal District), Mexico
Superare; Centro de Infusion, Ciudad de México, Mexico CITY (federal District), Mexico
Hospital Universitario; Dr. Jose E. Gonzalez, Monterrey, Nuevo LEON, Mexico
NKI/AvL, Amsterdam, , Netherlands
UMC St Radboud, Nijmegen, , Netherlands
Erasmus MC, Rotterdam, , Netherlands
Amethyst Cluj; Medical Oncology, Cluj County, , Romania
Institutul Oncologic Prof. Dr. Ion Chiricuta Cluj Napoca; Oncologie Medicala, Cluj Napoca, , Romania
Centrul de Oncologie Sfantul Nectarie, Craiova, , Romania
Institutul Regional de Oncologie Iasi, Iasi, , Romania
Emergency County Clinical Hospital Ploiesti; Medical oncology, Ploiesti, , Romania
Centrul de Oncologie Oncohelp, Timisoara, , Romania
AV Medical Ltd., Sait-Petersburg Sankt Petersburg, Sankt Petersburg, Russian Federation
Univerzitna nemocnica Bratislava; Oddelenie Klinickej Onkologie, Klinika Pneumologie A Ftizeologie, Bratislava, , Slovakia
Vychodoslovensky onkologicky ustav, Kosice, , Slovakia
Complejo Hospitalario Universitario A Coruña (CHUAC); Servicio de Oncologia, A Coruña, LA Coruña, Spain
Hospital del Mar; Servicio de Oncologia, Barcelona, , Spain
Institut Catala d Oncologia Hospital Duran i Reynals, Barcelona, , Spain
Hospital Ramon y Cajal; Servicio de Oncologia, Madrid, , Spain
Hospital Regional Universitario Carlos Haya; Servicio de Oncologia, Malaga, , Spain
Karolinska Universitetssjukhuset, Solna; Kliniska prövningsenheten Z:4:01, Stockholm, , Sweden
Chulalongkorn Hospital; Medical Oncology, Bangkok, , Thailand
Baskent University Adana Dr. Turgut Noyan Practice and Research Hospital; Medical Oncology, Adana, , Turkey
Gazi University Medical Faculty, Oncology Hospital, Ankara, , Turkey
Liv Hospital Ankara; Medical Oncology, Ankara, , Turkey
Ege Uni Medical Faculty Hospital; Oncology Dept, Izmir, , Turkey
Inonu University Medical Faculty Turgut Ozal Medical Center Medical Oncology Department, Malatya, , Turkey
Ac?badem Maslak Hastanesi Büyükdere, Sar?yer/?stanbul, , Turkey
Contact Details
Name: Clinical Trials
Affiliation: Hoffmann-La Roche
Role: STUDY_DIRECTOR
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