Spots Global Cancer Trial Database for A Study of Brigatinib Compared to Alectinib in Adults With Non-Small-Cell Lung Cancer
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Trial Identification
Brief Title: A Study of Brigatinib Compared to Alectinib in Adults With Non-Small-Cell Lung Cancer
Official Title: A Phase 3 Randomized Open-label Study of Brigatinib (ALUNBRIG®) Versus Alectinib (ALECENSA®) in Advanced Anaplastic Lymphoma Kinase-Positive Non-Small-Cell Lung Cancer Patients Who Have Progressed on Crizotinib (XALKORI®)
Study ID: NCT03596866
Conditions
Study Description
Brief Summary: Brigatinib is a medicine that binds to the surface of tumor cells in some cancers and delivers a dose of chemotherapy directly to the tumor. In this study, participants will be people with non-small-cell lung cancer (NSCLC for short). The main aim of the study is to learn if brigatinib stops the tumors from growing, or if the tumors have shrunk or disappeared, compared to a medicine called alectinib. At the first visit, the study doctor will check who can take part. Participants who can take part will be picked for 1 of 2 treatments by chance: * Brigatinib tablets * Alectinib capsules All participants will take brigatinib or alectinib at about the same time every day. They will continue with treatment throughout the study unless their cancer gets worse, they have side effects from the treatment, they leave the study for certain reasons, or the study is stopped. After stopping treatment, participants will visit the study clinic for a check-up 30 days later.
Detailed Description: The drug being tested in this study is called brigatinib. Brigatinib has been demonstrated to benefit people with ALK+ NSCLC. The comparator drug is called alectinib. Alectinib has been demonstrated to benefit people with ALK+ NSCLC. Both drugs belong to a class of drugs called anaplastic lymphoma kinase (ALK) inhibitors. Both drugs are taken by mouth. Both drugs are approved by the United States Food and Drug Administration (US FDA). The study will enroll approximately 246 participants. Participants will be randomly assigned (by chance, like flipping a coin) in 1:1 ratio to one of the two treatment groups: * Brigatinib * Alectinib All participants will be asked to take brigatinib or alectinib at the same time each day throughout the study. This multi-center trial will be conducted in the United States, Argentina, Austria, Canada, Chile, China, Croatia, France, Germany, Greece, Hong Kong, Italy, Mexico, Romania, Russia, South Korea, Spain, Sweden, Taiwan, and Thailand. The overall time to participate in this study is 5 years. Participants will make multiple visits to the clinic, and 30 days after last dose of study drug for a follow-up assessment.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
The Oncology Institute of Hope and Innovation, Whittier, California, United States
University Cancer and Blood Center, Athens, Georgia, United States
New York Oncology Hematology - Albany Medical Center, Albany, New York, United States
Virginia Cancer Specialists, Fairfax, Virginia, United States
Centro Para la Atencion Integral del Paciente Oncologico, San Miguel De Tucuman, Tucuman, Argentina
Sanatorio Duarte Quiros, Cordoba, , Argentina
Centro Oncologico Riojano Integral, La Rioja, , Argentina
Klinikum Klagenfurt Am Worthersee, Klagenfurt am Worthersee, Carinthia, Austria
Queen Elizabeth II Health Sciences Centre, Halifax, Nova Scotia, Canada
Toronto University Health Network, Toronto, Ontario, Canada
Centro de Investigacion Clinica Bradford Hill, Recoleta, Santiago, Chile
Beijing Chest Hospital, Beijing, Beijing, China
Peking Union Medical College Hospital - East, Beijing, Beijing, China
Peking University Cancer Hospital/Beijing Cancer Hospital, Beijing, Beijing, China
The 307th Hospital of Chinese Peoples Liberation Army, Beijing, Beijing, China
Beijing Cancer Hospital, Beijing, Beijing, China
The First Affiliated Hospital of Guangzhou Medical University, Guangzhou, Guangdong, China
Affiliated Tumor Hospital of Harbin Medical University - The 3rd Affiliated Hospital of HMU, Harbin, Heilongjiang, China
Henan Cancer Hospital, Zhengzhou, Henan, China
Jilin Provincial Cancer Hospital (Changchun Cancer Hospital), Changchun, Jilin, China
Shanghai Chest Hospital, Shanghai, Shanghai, China
Chang Gung Memorial Hospital Linkou Branch, Tianjin, Tianjin, China
Tianjin Medical University Cancer Institute & Hospital, Tianjin, Tianjin, China
Zhejiang Cancer Hospital, Hangzhou, Zhejiang, China
The First Affiliated Hospital, Zhejiang University, Hangzhou, Zhejiang, China
Fudan University Shanghai Cancer Center, Dubrovnik, Dubrovnik-Neretva, Croatia
Opca bolnica Dubrovnik, Dubrovnik, Dubrovnik-Neretva, Croatia
General Hospital Pula, Pula, , Croatia
Klinicki bolnicki centar Sestre milosrdnice, Zagreb, , Croatia
Klinika za Pulmologiju, Zagreb, , Croatia
Hopital Haut-Leveque, Pessac, Aquitaine, France
Centre Hospitalier Intercommunal de Creteil, Creteil, Ile-de-france, France
Fudan University Shanghai Cancer Center, Creteil, Ile-de-france, France
Hopital Foch, Suresnes, Ile-de-france, France
Gustave Roussy, Villejuif cedex, Ile-de-france, France
Centre Hospitalier Universitaire de Toulouse- Hopital Larrey, Toulouse Cedex 9, Midi-pyrenees, France
Centre Hospitalier Le Mans, Le Mans Cedex 9, PAYS DE LA Loire, France
Centre Hospitalier Intercommunal Toulon - La Seyne Sur Mer, Toulon, Provence Alpes COTE D'azur, France
Hopital Albert Michallon, Grenoble Cedex 9, Rhone-alpes, France
Thoraxklinik Heidelberg, Heidelberg, Baden-wuerttemberg, Germany
Asklepios Fachkliniken Munchen-Gauting, Gauting, Bayern, Germany
Klinikum Kempten-Oberallgau, Immenstadt, Bayern, Germany
University General Hospital of Athens Attikon, Athens, Attica, Greece
Iaso General Hospital, Cholargos, Attica, Greece
General Oncology Hospital of Kifisia Oi Agioi Anargiroi, Nea Kifisia, Attica, Greece
Interbalkan Medical Center of Thessaloniki, Thessaloniki, Macedonia, Greece
University General Hospital of Larissa, Larissa, Thessaly, Greece
Sotiria General Hospital for Respiratory Diseases of Attica, Athens, , Greece
Pamela Youde Nethersole Eastern Hospital, Chai Wan, Eastern District, Hong Kong
Humanity and Health Research Centre, Central, , Hong Kong
Queen Mary Hospital, Hong Kong, , Hong Kong
Queen Mary Hospital, Hong Kong, , Hong Kong
Hong Kong United Oncology Centre, Kowloon, , Hong Kong
Princess Margaret Hospital, Kowloon, , Hong Kong
Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori, Meldola, Forli-cesena, Italy
Centro di Riferimento Oncologico di Aviano, Aviano, Pordenone, Italy
Azienda Ospedaliero Universitaria di Bologna Policlinico Sant'Orsola-Malpighi, Bologna, , Italy
Azienda Ospedaliera Universitaria San Martino, Genova, , Italy
Istituto Scientifico Universitario San Raffaele, Milano, , Italy
Istituto Nazionale Tumori IRCCS Fondazione Pascale, Napoli, , Italy
Ospedale Santa Maria delle Croci, Ravenna, , Italy
Chungbuk National University Hospital, Cheongju-si, Chungcheongbuk-do, Korea, Republic of
National Cancer Center, Goyang-si, Gyeonggi-do, Korea, Republic of
Gachon University Gil Medical Center, Incheon, Gyeonggi-do, Korea, Republic of
The Catholic University of Korea St. Vincent's Hospital, Suwon-si, Gyeonggi-do, Korea, Republic of
Ajou University Hospital, Suwon, Gyeonggi-do, Korea, Republic of
Ulsan University Hospital, Ulsan, Gyeongsangnam-do, Korea, Republic of
Korea University Anam Hospital, Seoul, , Korea, Republic of
Seoul National University Hospital, Seoul, , Korea, Republic of
Samsung Medical Center, Seoul, , Korea, Republic of
The Catholic University of Korea - Seoul St. Mary's Hospital, Seoul, , Korea, Republic of
Medica Sur, Ciudad de Mexico, Cdmx, Mexico
Centro de Investigacion Medica Aguascalientes, Aguascalientes, , Mexico
Institutul Oncologic Prof. Dr. Ion Chiricu, Cluj-Napoca, Cluj, Romania
Oncocenter- Oncologie Clinica, Timisoara, Timis, Romania
Institutul Oncologic Prof. Dr. Alexandru Trestioreanu Bucaresti, Bucuresti, , Romania
Centrul de oncologie Euroclinic, Iasi, , Romania
State Institution of Healthcare Arkhangelsk Regional Clinical Oncology Dispensary, Arkhangelsk, Arkhangelr, Russian Federation
Euromedservice, Saint-Petersburg, Saint Petersburg, Russian Federation
Saint Petersburg Clinical Scientific and Practical Center of Specialized Types of Medical Aid, Saint-Petersburg, Saint Petersburg, Russian Federation
Clinica Ultra Sound Diagnostic 4D, Pyatigorsk, Stavropol, Russian Federation
Irkutsk Regional Oncology Center, Irkutsk, , Russian Federation
N.N. Blokhin Russian Cancer Research Center, Moscow, , Russian Federation
VitaMed, Moscow, , Russian Federation
State Budget Institution National Medical Research Center of Radiology of the Ministry of Heal, Moscow, , Russian Federation
Moscow City Oncology Hospital Number 62, Moscow, , Russian Federation
Omsk Regional Clinical Oncologic Dispensary, Omsk, , Russian Federation
Leningrad Regional Clinical Hospital, Saint Petersburg, , Russian Federation
Center of Palliative Medicine - Devita, Saint Petersburg, , Russian Federation
Saint Petersburg State Healthcare Institution Municipal Clinical Oncology Dispensary, Saint Petersburg, , Russian Federation
Hospital Universitari Germans Trias i Pujol, Badalona, Barcelona, Spain
Hospital Teresa Herrera - Materno Infantil, A Coruna, LA Coruna, Spain
Hospital Universitari Vall d'Hebron, Barcelona, , Spain
Hospital Clinic i Provincial de Barcelona, Barcelona, , Spain
Hospital General Universitario Gregorio Maranon, Madrid, , Spain
Hospital Universitario Ramon Y Cajal, Madrid, , Spain
Hospital Clinico San Carlos, Madrid, , Spain
Hospital Universitario 12 de Octubre, Madrid, , Spain
Hospital Universitario La Paz, Madrid, , Spain
Hospital Regional Universitario de Malaga, Malaga, , Spain
Hospital Universitari Sant Joan de Reus, Reus, , Spain
Hospital Universitario Virgen Macarena, Sevilla, , Spain
Karolinska Universitetssjukhuset - Solna, Solna, Stockholm, Sweden
Uppsala Akademiska Sjukhus, Uppsala, , Sweden
Changhua Christian Hospital, Changhua City, , Taiwan
Hualien Tzu Chi Hospital, Hualien City, , Taiwan
Kaohsiung Medical University Hospital, Kaohsiung, , Taiwan
Chi Mei Hospital Liouying, Tainan City, , Taiwan
National Cheng Kung University Hospital, Tainan, , Taiwan
National Taiwan University Hospital, Taipei, , Taiwan
Chang Gung Memorial Hospital Linkou Branch, Taoyuan City, , Taiwan
King Chulalongkorn Memorial Hospital, Bangkok, Bangkok Metropolis, Thailand
Phramongkutklao Hospital, Bangkok, Bangkok Metropolis, Thailand
Songklanagarind Hospital, Songkhla, , Thailand
Contact Details
Name: Medical Director Clinical Science
Affiliation: Takeda
Role: STUDY_DIRECTOR
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