Spots Global Cancer Trial Database for ALTA-1L Study: A Study of Brigatinib Versus Crizotinib in Anaplastic Lymphoma Kinase Positive (ALK+) Advanced Non-small Cell Lung Cancer (NSCLC) Participants
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Trial Identification
Brief Title: ALTA-1L Study: A Study of Brigatinib Versus Crizotinib in Anaplastic Lymphoma Kinase Positive (ALK+) Advanced Non-small Cell Lung Cancer (NSCLC) Participants
Official Title: A Phase 3 Multicenter Open-label Study of Brigatinib (AP26113) Versus Crizotinib in Patients With ALK-positive Advanced Lung Cancer
Study ID: NCT02737501
Study Description
Brief Summary: The purpose of the study is to compare the efficacy of brigatinib to that of crizotinib in ALK+ locally advanced or metastatic non-small cell lung cancer (NSCLC) participants naive to ALK inhibitors, as evidenced by progression-free survival (PFS).
Detailed Description: The purpose of this phase III, randomized, open-label, comparative, multicenter, international study is to compare the efficacy and safety of brigatinib to that of crizotinib in ALK+ locally advanced or metastatic NSCLC participants who have not previously been treated with an ALK inhibitor. Participants will be stratified by the presence of CNS metastases at baseline and prior chemotherapy used for locally advanced or metastatic disease. Participants will be randomized in a 1:1 ratio to receive either brigatinib, 90 mg orally once daily (QD) for 7 days, then a 180 mg orally QD, or crizotinib, 250 mg orally twice daily (BID). Participants will receive treatment until disease progression, intolerable toxicity, consent withdrawal, or death. Crossover from crizotinib to brigatinib is also permitted. The total estimated duration of the study is at least 4.5 years, including 1.5 years to accrue participants, with at least 3 years for treatment and follow-up.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
USOR - Arizona Oncology Associates - Sedona, Sedona, Arizona, United States
Kaiser Permanente Bellflower Medical Offices, Bellflower, California, United States
University of Colorado Cancer Center, Aurora, Colorado, United States
Rocky Mountain Cancer Centers - Boulder, Boulder, Colorado, United States
Sylvester Comprehensive Cancer Center, Deerfield Beach, Florida, United States
Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States
West Michigan Cancer Center, Kalamazoo, Michigan, United States
Minnesota Oncology, Coon Rapids, Minnesota, United States
Montefiore Medical Center, Bronx, New York, United States
Oncology Hematology Care - Blue Ash, Cincinnati, Ohio, United States
Stephenson Cancer Center, Oklahoma City, Oklahoma, United States
Virginia Cancer Specialists - Fairfax Office, Fairfax, Virginia, United States
Saint George Hospital, Kogarah, New South Wales, Australia
Royal North Shore Hospital, St Leonards, New South Wales, Australia
Monash Medical Centre, Bentleigh East, Victoria, Australia
Saint Vincent's Hospital Melbourne, Fitzroy, Victoria, Australia
Universitatsklinium St. Polten, Sankt Polten, Lower Austria, Austria
Otto-Wagner-Spital Baumgartner Hohe, Vienna, , Austria
Princess Margaret Cancer Centre, Toronto, Ontario, Canada
Odense University Hospital, Odense C, , Denmark
Centre de Lutte Contre le Cancer Francois Baclesse, CAEN Cedex 5, Basse-normandie, France
Hopital Charles Nicolle, Rouen, Haute-normandie, France
Centre Hospitalier Intercommunal de Creteil, Creteil, Ile-de-france, France
Hopital Tenon, Paris, Ile-de-france, France
Centre Hospitalier Universitaire Hopital Nord, Marseille Cedex 20, Provence Alpes COTE D'azur, France
Hopital Albert Michallon, Grenoble Cedex 9, Rhone-alpes, France
Centre Leon Berard, Lyon, Rhone-alpes, France
Universitatsklinik Freiburg, Freiburg, Baden-wuerttemberg, Germany
Thoraxklinik Heidelberg gGmbH, Heidelberg, Baden-wuerttemberg, Germany
Pius Hospital Oldenburg, Oldenburg, Niedersachsen, Germany
Kliniken der Stadt Koeln gGmbH - Krankenhaus Merheim, Koln, Nordrhein-westfalen, Germany
Evangelische Lungenklinik Berlin, Berlin, , Germany
Studiengesellschaft Haemato-Onkologie Hamburg Prof. Laack und Partner, Hamburg, , Germany
Tuen Mun Hospital, Tuen Mun, New Territories, Hong Kong
Queen Mary Hospital, Hong Kong, , Hong Kong
Queen Elizabeth Hospital, Kowloon, , Hong Kong
Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori, Meldola, Forli-cesena, Italy
Azienda Ospedaliera San Gerardo di Monza, Monza, Monza E Brianza, Italy
Centro di Riferimento Oncologico di Aviano, Aviano, Pordenone, Italy
Azienda Ospedaliera San Giuseppe Moscati, Avellino, , Italy
Istituto Oncologico di Bari Giovanni Paolo II, Bari, , Italy
Azienda Ospedaliero Universitaria di Bologna Policlinico Sant'Orsola-Malpighi, Bologna, , Italy
Istituto Scientifico Universitario San Raffaele, Milano, , Italy
Istituto Europeo di Oncologia, Milano, , Italy
Istituto Tumori Napoli Fondazione G. Pascale, Napoli, , Italy
Azienda Ospedaliero Universitaria Maggiore della Carita, Novara, , Italy
Azienda Ospedaliera di Perugia - Ospedale S. Maria della Misericordia, Perugia, , Italy
Azienda Unita Sanitaria Locale di Ravenna, Ravenna, , Italy
Policlinico Universitario Campus Bio-Medico, Roma, , Italy
Chungbuk National University Hospital, Cheongju, Chungcheongbuk-do, Korea, Republic of
National Cancer Center, Goyang-si, Gyeonggi-do, Korea, Republic of
Seoul National University Bundang Hospital, Seongnam-si, Gyeonggi-do, Korea, Republic of
Seoul National University Hospital, Seoul, , Korea, Republic of
Severance Hospital, Seoul, , Korea, Republic of
Asan Medical Center, Seoul, , Korea, Republic of
Samsung Medical Center, Seoul, , Korea, Republic of
The Catholic University of Korea, Seoul, , Korea, Republic of
Centre Hospitalier de Luxembourg - Hopital Municipal, Luxembourg, , Luxembourg
Amphia Ziekenhuis - Locatie Langendijk Breda, Breda, Noord-brabant, Netherlands
Antoni van Leeuwenhoekziekenhuis, Amsterdam, Noord-holland, Netherlands
Isala Klinieken, Zwolle, Overijssel, Netherlands
Universitair Medisch Centrum Groningen, Groningen, , Netherlands
Radiumhospitalet, Oslo, , Norway
National University Hospital, Singapore, , Singapore
National Cancer Centre Singapore, Singapore, , Singapore
OncoCare Cancer Centre, Singapore, , Singapore
Hospital Universitario Central de Asturias, Oviedo, Asturias, Spain
Hospital Universitari Germans Trias i Pujol, Badalona, Barcelona, Spain
Hospital Universitario Puerta de Hierro - Majadahonda, Majadahonda, Madrid, Spain
Hospital General Universitario de Alicante, Alicante, , Spain
Hospital Universitario Vall d'Hebron, Barcelona, , Spain
Hospital Teresa Herrera - Materno Infantil, La Coruna, , Spain
Hospital Ramon Y Cajal, Madrid, , Spain
Hospital Universitario La Paz, Madrid, , Spain
Hospital Regional Universitario Carlos Haya Malaga Instituto de Neurociencias Clinicas, Malaga, , Spain
Hospital Universitario Marques de Valdecilla, Santander, , Spain
Hospital Universitario Virgen del Rocio, Sevilla, , Spain
Hospital Clinico Universitario de Valencia, Valencia, , Spain
Karolinska Universitetssjukhuset, Stockholm, , Sweden
University Hospital Zurich, Zurich, , Switzerland
National Cheng Kung University, Tainan, Taipei, Taiwan
China Medical University Hospital, Taichung, , Taiwan
Taichung Veterans General Hospital, Taichung, , Taiwan
National Taiwan University Hospital, Taipei, , Taiwan
Taipei Veterans General Hospital, Taipei, , Taiwan
Leicester Royal Infirmary, Leicester, England, United Kingdom
University College London, London, England, United Kingdom
Guy's and Saint Thomas' NHS Foundation Trust, London, England, United Kingdom
Royal Marsden NHS Trust, London, England, United Kingdom
Maidstone Hospital, Maidstone, England, United Kingdom
The Christie NHS Foundation Trust, Manchester, England, United Kingdom
Contact Details
Name: Medical Director
Affiliation: Takeda
Role: STUDY_DIRECTOR
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