Spots Global Cancer Trial Database for eXalt3: Study Comparing X-396 (Ensartinib) to Crizotinib in ALK Positive Non-Small Cell Lung Cancer (NSCLC) Patients
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Trial Identification
Brief Title: eXalt3: Study Comparing X-396 (Ensartinib) to Crizotinib in ALK Positive Non-Small Cell Lung Cancer (NSCLC) Patients
Official Title: Phase 3 Randomized Study Comparing X-396 (Ensartinib) to Crizotinib in Anaplastic Lymphoma Kinase (ALK) Positive Non-Small Cell Lung Cancer (NSCLC) Patients
Study ID: NCT02767804
Conditions
Study Description
Brief Summary: The primary purpose of this study is to evaluate the efficacy and safety of X-396 (ensartinib) vs. crizotinib in patients with ALK-positive non-small cell lung cancer that have received up to 1 prior chemotherapy regimen and no prior ALK inhibitor.
Detailed Description: To evaluate the efficacy and safety of X-396 (ensartinib) vs. crizotinib in patients with ALK-positive NSCLC that have received up to 1 prior chemotherapy regimen and no prior ALK tyrosine kinase inhibitor (TKI), to obtain additional pharmacokinetic (PK) data from sparse PK sampling, to compare the quality of life (QoL) in patients receiving X-396 vs. crizotinib, to evaluate the status of exploratory biomarkers and correlate with clinical outcome, and to obtain germline DNA samples for possible pharmacogenetic analysis in the event that outliers with respect to efficacy, tolerability/safety, or exposure are identified.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Moffitt Cancer Center, Tampa, Florida, United States
University Cancer & Blood Center, Athens, Georgia, United States
Washington University School of Medicine, Saint Louis, Missouri, United States
Providence Portland Medical Center, Portland, Oregon, United States
Sanatorio Parque S.A., Rosario, , Argentina
Border Medical Oncology Research Unit, Albury, New South Wales, Australia
Chris O'Brien Lifehouse, Camperdown, New South Wales, Australia
Chris O Brien Lifehouse, Camperdown, , Australia
Catholic University of Louvain (UCL) - Site Mont Godinne, Yvoir, , Belgium
Instituto do Câncer do Estado de São Paulo, São Paulo, SP, Brazil
Hospital de Câncer de Barretos - Fundação Pio XII, São Paulo, SP, Brazil
Hospital Haroldo Juaçaba - Instituto do Cancêr do Ceará, Fortaleza, , Brazil
Fundacao do ABC Faculdade de Medicina do ABC, São Paulo, , Brazil
Infirmière recherche Clinique, IUCPQ, Quebec City, Quebec, Canada
Anhui Provincial Hospital, Hefei, Anhui, China
Beijing Chao Yang Hospital, Beijing, Beijing, China
Peking Union Medical College Hospital, Beijing, Beijing, China
Peking University Cancer Hospital, Beijing, Beijing, China
Beijing Chest Hospital,Capital Medical University, Beijing, Beijing, China
Fujian Provincial Cancer Hospital, Fuzhou, Fujian, China
Guangdong General Hospital, Guangzhou, Guangdong, China
Fourth Hospital of Hebei Medical University, Shijiazhuang, Hebei, China
Union Hospital of Tongji Medical College of Huazhong Science and Techology University, Wuhan, Hubei, China
Tongji Hospital, Tongji Medical College, Huazhong University of Science & Technology, Wuhan, Hubei, China
Hubei Cancer Hospital, Wuhan, Hubei, China
Hunan Cancer Hospital, Changsha, Hunan, China
Nanjing General Hospital, Nanjing, Jiangsu, China
The First Bethune Hospital of Jilin University, Changchun, Jilin, China
Jilin Cancer Hospital, Changchun, Jilin, China
The First Hospital of China Medical University, Shenyang, Liaoning, China
The Affiliated Hospital of Qingdao University, Qingdao, Shandong, China
Shanghai Chest Hospital, Shanghai, Shanghai, China
Zhejiang Cancer Hospital, Hangzhou, Zhejiang, China
Peking University Cancer Hospital, Beijing, , China
Zhejiang Cancer Hospital, Hangzhou, , China
Vítkovická Nemocnice , a.s., Ostrava-Vitkovice, , Czechia
Krajská zdravotní, a.s., Masarykova nemocnice, Usti nad Labem, , Czechia
CHRU Lille, Lille, , France
Hopital Arnaud de Villeneuve, Montpellier, , France
CHU de Rennes Hôpital Pontchaillou, Rennes, , France
Hopital Saint-Louis, Vellefaux, , France
Charite Campus Virchow-Klinikum, Berlin, , Germany
Lungen Clinic Grosshansdorf, Grosshansdorf, , Germany
Prince of Wales Hospital, Hong Kong, , Hong Kong
Queen Elizabeth Hospital, Hong Kong, , Hong Kong
The University of Hong Kong/Queen Mary Hospital, Hong Kong, , Hong Kong
Prince of Wales Hospital, Sha Tin, , Hong Kong
Hadassah Medical Center, Jerusalem, , Israel
Rabin Medical Center Institute of Oncology, Davidoff Center, Petah Tiqva, , Israel
IEO Istituto Europeo di Oncologia, Milano, , Italy
Centro Operativo Studi Clinici S.C.Oncologia Medica, Perugia, , Italy
Azienda Socio Sanitaria Territoriale (ASST) della Valtellina e dell'Alto Laria, Sondrio, , Italy
Seoul National University Hospital, Seoul, , Korea, Republic of
Asan Medical Center, Seoul, , Korea, Republic of
VU Medical Center, Amsterdam, , Netherlands
Maastricht University Medical Centre (MUMC), Maastricht, , Netherlands
Medical University of Gdansk, Gdańsk, , Poland
Federal State Budgetary Scientific Institution Russian Oncological Scientific Center named after N.N. Blokhin, Moscow, , Russian Federation
LLC "Vitamed", Moscow, , Russian Federation
Moscow City Oncology Hospital #63, Moscow, , Russian Federation
BIH of Omsk Region "Clinical Oncology Dispensary", Omsk, , Russian Federation
Pavlov First Medical University, Saint Petersburg, , Russian Federation
Petrov Research Institute of Oncology, Saint Petersburg, , Russian Federation
Hospital del Mar, Barcelona, , Spain
Hospital de la Santa Creu i Sant Pau, Barcelona, , Spain
Hospital Vall d'Hebrón, Barcelona, , Spain
Hospital Son Ltatzer, Palma de Mallorca, , Spain
Trakya University Balkan Oncology Hospital, Edirne, , Turkey
Blackpool Victoria Hospital, Blackwood, , United Kingdom
Southmead Hospital, Bristol, , United Kingdom
Kings Mill Hospital, Nottingham, , United Kingdom
The Clatterbridge Cancer Centre NHS Foundation Trust, Wirral, , United Kingdom
Contact Details
Name: Giovanni Selvaggi, MD
Affiliation: CEO
Role: STUDY_CHAIR
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