Spots Global Cancer Trial Database for A Study Comparing Alectinib With Crizotinib in Treatment-Naive Anaplastic Lymphoma Kinase-Positive Advanced Non-Small Cell Lung Cancer Participants
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Trial Identification
Brief Title: A Study Comparing Alectinib With Crizotinib in Treatment-Naive Anaplastic Lymphoma Kinase-Positive Advanced Non-Small Cell Lung Cancer Participants
Official Title: Randomized, Multicenter, Phase III, Open-Label Study of Alectinib Versus Crizotinib in Treatment-Naive Anaplastic Lymphoma Kinase-Positive Advanced Non-Small Cell Lung Cancer
Study ID: NCT02075840
Conditions
Study Description
Brief Summary: This randomized, active controlled, multicenter phase III open-label study is designed to evaluate the efficacy and safety of alectinib compared with crizotinib treatment in participants with treatment-naive anaplastic lymphoma kinase-positive (ALK-positive) advanced non-small cell lung cancer (NSCLC). Participants will be randomized in a 1:1 ratio to receive either alectinib, 600 milligrams (mg) orally twice daily (BID), or crizotinib, 250 mg orally BID. Participants will receive treatment until disease progression, unacceptable toxicity, withdrawal of consent, or death. The study is expected to last approximately 144 months.
Detailed Description:
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Banner MD Anderson Cancer Center, Gilbert, Arizona, United States
Mayo Clinic Arizona, Phoenix, Arizona, United States
North Valley Hem Onc Med Grp; Thomas&Dorothy Leavey Can Ctr, Northridge, California, United States
Chao Family Comprehensive Cancer Center; UC Irvine Medical Center, Orange, California, United States
TMPN/ Cancer Care Associates, Redondo Beach, California, United States
UCSF Helen Diller Family CCC, San Francisco, California, United States
University of Colorado Cancer Center, Aurora, Colorado, United States
St. Mary's Hospital Regional Cancer Center, Grand Junction, Colorado, United States
University of Miami-Deerfield Beach, Deerfield Beach, Florida, United States
Cancer Institute of Florida PA, Orlando, Florida, United States
Memorial Health Care System, Pembroke Pines, Florida, United States
Emory University Hospital, Atlanta, Georgia, United States
Northwest Georgia Oncology Centers, a Service of WellStar Cobb Hospital, Marietta, Georgia, United States
University of Illinois at Chicago, Chicago, Illinois, United States
Massachusetts General Hospital Cancer Center, Boston, Massachusetts, United States
Beth Israel Deaconess Med Ctr; Hem/Onc, Boston, Massachusetts, United States
Dana Farber Can Ins, Boston, Massachusetts, United States
Karmanos Cancer Institute, Detroit, Michigan, United States
Henry Ford Health System, Detroit, Michigan, United States
Washington Uni School of Medicine, Saint Louis, Missouri, United States
Comprehensive Cancer Center - Peak, Las Vegas, Nevada, United States
Columbia University Medical Center, New York, New York, United States
SCRI Oncology Partners, Nashville, Tennessee, United States
UT Southwestern Medical Center, Dallas, Texas, United States
University of Texas M.D. Anderson Cancer Center, Houston, Texas, United States
Kinghorn Cancer Centre; St Vincents Hospital, Darlinghurst, New South Wales, Australia
Royal North Shore Hospital; Oncology, St. Leonards, New South Wales, Australia
Calvary Mater Newcastle; Medical Oncology, Waratah, New South Wales, Australia
Queen Elizabeth Hospital; Medical Oncology, Woodville South, South Australia, Australia
Monash Health Translational Precinct; Clinical Trials Centre, Level 3, Victoria, , Australia
University Clinical Centre of the Republic of Srpska; Clinic for Pulmonary Diseases, Banja Luka, , Bosnia and Herzegovina
University Clinical Center Sarajevo;Clinic for Pulmonary disease, Sarajevo, , Bosnia and Herzegovina
University Clinical Center Sarajevo;Institute of oncology, Sarajevo, , Bosnia and Herzegovina
Hospital das Clinicas - UFRGS, Porto Alegre, RS, Brazil
Instituto do Cancer do Estado de Sao Paulo - ICESP, Sao Paulo, SP, Brazil
Cross Cancer Institute, Edmonton, Alberta, Canada
Sunnybrook Odette Cancer Centre, Toronto, Ontario, Canada
Mount Sinai Hospital; Oncology, Toronto, Ontario, Canada
Saskatoon Cancer Centre; Uni of Saskatoon Campus, Saskatoon, Saskatchewan, Canada
Centro Internacional de Estudios Clínicos (CIEC), Recoleta, , Chile
Sun Yet-sen University Cancer Center, Guangzhou City, , China
Shanghai Pulmonary Hospital, Shanghai, , China
Clinica CIMCA, San José, , Costa Rica
Kasr Eieny Uni Hospital; Oncology (Nemrock), Cairo, , Egypt
Chu Grenoble - Hopital Albert Michallon; Departement de Cancero-Hematologie, Grenoble, , France
CHRU de Lille, Lille, , France
Centre Leon Berard; Departement Oncologie Medicale, Lyon, , France
Hopital Haut Leveque, Pessac, , France
Hopital Pontchaillou, Rennes, , France
St. Vincentius Kliniken Karlsruhe; Abteilung Hämatologie / Onkologie, Karlsruhe, , Germany
Klinik Löwenstein gGmbH Medizinische Klinik II, Löwenstein, , Germany
Grupo Angeles, Guatemala City, , Guatemala
Pamela Youde Nethersole Eastern Hospital; Clinical Oncology, Hong Kong, , Hong Kong
Princess Margaret Hospital; Oncology, Hong Kong, , Hong Kong
Queen Mary Hospital; Medicine & Respiratory, Hong Kong, , Hong Kong
Tuen Mun Hospital; Clinical Oncology, Hong Kong, , Hong Kong
Prince of Wales Hosp; Dept. Of Clinical Onc, Shatin, , Hong Kong
Rambam Medical Center; Oncology, Haifa, , Israel
Meir Medical Center; Oncology, Kfar-Saba, , Israel
Seconda Universita' Degli Studi; Divsione Di Oncologia Medica, Napoli, Campania, Italy
A.O. Universitaria Di Parma; Oncologia Medica, Parma, Emilia-Romagna, Italy
Ospedale Provinciale Santa Maria Delle Croci; Oncologia Medica, Ravenna, Emilia-Romagna, Italy
Policlinico Umberto i di Roma; dip. Scienze Radiologiche, Oncologiche, Anatomopatologiche, Roma, Lazio, Italy
Irccs Istituto Nazionale Dei Tumori (Int);S.C. Medicina Oncologica 1, Milano, Lombardia, Italy
Irccs Istituto Europeo Di Oncologia (IEO); Oncologia Medica, Milano, Lombardia, Italy
Az. Osp. S. Luigi Gonzaga; Malattie Apparato Respiratorio 5 Ad Indirizzo Oncologico, Orbassano, Piemonte, Italy
Irccs Ist. Tumori Giovanni Paolo Ii; Dipartimento Oncologia Medica, Bari, Puglia, Italy
Az Ospedaliera Nuovo Garibaldi Quartiere Nesima; Oncologia Medica, Catania, Sicilia, Italy
Azienda Ospedaliera Di Perugia Ospedale s. Maria Della Misericordia; Oncologia Medica, Sant'Andrea Delle Fratte (PG), Umbria, Italy
National Cancer Center, Goyang-si, , Korea, Republic of
Seoul National University Bundang Hospital, Seongnam-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
Samsung Medical Center, Seoul, , Korea, Republic of
Instituto Nacional De Enfermedades Respiratorias;Unidad de Investigación, Ciudad de México, Mexico CITY (federal District), Mexico
Uni of Auckland; Medical School, Auckland, , New Zealand
Uniwersyteckie Centrum Kliniczne; Klinika Onkologii i Radioterapii, Gdansk, , Poland
Ms Clinsearch Specjalistyczny Niepubliczny Zaklad Opieki Zdrowotnej, Lublin, , Poland
Warminsko-Mazurskie Centrum Chorób P?uc w Olsztynie; Oddzial onkologii z pododdzialem chemioterapii, Olsztyn, , Poland
Mazowieckie Centrum Leczenia Chorob Pluc I Gruzlicy; Oddzial Iii, Otwock, , Poland
Centrum Onkologii - Inst.Im. Marii Sklodowskiej-Curie; Oncology, Warszawa, , Poland
CHUC - Unidade de Pneumologia Oncológica; Hospital de Dia de Oncologia Edificio Sao Jeronimo, Coimbra, , Portugal
IPO de Lisboa; Servico de Pneumologia, Lisboa, , Portugal
IPO do Porto; Servico de Oncologia Medica, Porto, , Portugal
Medical Radiological Research Centre Rams; Dept. of Radiotherapy & Chemotherapy of Hemoblastosis, Obninsk, Kaluga, Russian Federation
Moscow City Oncology Hospital #62, Moscovskaya Oblast, Moskovskaja Oblast, Russian Federation
N.N.Burdenko Main Military Clinical Hospital; Oncology Dept, Moscow, Moskovskaja Oblast, Russian Federation
SPb City Clin Onc Dsp; Chemotherapy, Sankt-peterburg, Sankt Petersburg, Russian Federation
Scientific Research Oncology Institute named after N.N. Petrov; Oncology, St. Petersburg, Sankt Petersburg, Russian Federation
City Clinical Hospital No. 1, Novosibirsk, , Russian Federation
Clinical Center of Serbia, Belgrade, , Serbia
Institute for pulmonary diseases of Vojvodina, Sremska Kamenica, , Serbia
National University Hospital; National University Cancer Institute, Singapore (NCIS), Singapore, , Singapore
National Cancer Centre; Medical Oncology, Singapore, , Singapore
Hospital Universitari Germans Trias i Pujol; Servicio de Oncologia, Badalona, Barcelona, Spain
Hospital Univ Vall d'Hebron; Servicio de Oncologia, Sant Andreu de La Barca, Barcelona, Spain
Hospital Universitario Puerta de Hierro; Servicio de Oncologia, Majadahonda, Madrid, Spain
Hospital General Univ. de Alicante; Servicio de Oncologia, Alicante, , Spain
Hospital Universitario Quiron Dexeus, Barcelona, , Spain
Hospital Universitario Virgen del Rocio; Servicio de Oncologia, Sevilla, , Spain
Universitaetsspital Basel; Onkologie, Basel, , Switzerland
Inselspital Bern; Universitätsklinik für Medizinische Onkologie, Klinische Forschungseinheit, Bern, , Switzerland
CHUV; Departement d'Oncologie, Lausanne, , Switzerland
UniversitätsSpital Zürich; Zentrum für Hämatologie und Onkologie, Klinik für Onkologie, Zürich, , Switzerland
National Cheng Kung Univ Hosp, Tainan, , Taiwan
Taipei Veterans General Hospital, Taipei City, , Taiwan
National Taiwan University Hospital, Taipei, , Taiwan
Taichung Veterans General Hospital, Xitun Dist., , Taiwan
National Cancer Inst., Bangkok, , Thailand
Chiang Rai Prachanukroh Hospital; Department Of Medicine, Chiang Rai, , Thailand
Khonkaen Hospital, Khonkaen, , Thailand
King Chulalongkorn Memorial Hospital; Faculty of Medicine Chulalongkorn University, Patumwan, , Thailand
Songklanagarind Hospital; Department of Internal Medicine, Division of Respiratory, Songkhla, , Thailand
Baskent University Adana Dr. Turgut Noyan Practice and Research Hospital; Medical Oncology, Adana, , Turkey
Ankara University Medical Faculty; Medikal Onkoloji, Ankara, , Turkey
Trakya University Medical Faculty Research And Practice Hospital Medical Oncology Department, Edirne, , Turkey
Inonu University Medical Faculty Turgut Ozal Medical Center Medical Oncology Department, Malatya, , Turkey
Dnipropetrovsk State Medical Academy; Chemotherapy Department, Dnipropetrovsk, , Ukraine
Karkiv Regional Oncology Center, Kharkiv, , Ukraine
Kyiv Regional Oncological Dispensary, Kyiv, , Ukraine
Lviv State Oncology Regional Treatment and Diagnostic Centre; Department of hemotherapy, Lviv, , Ukraine
Birmingham Heartlands Hospital; Dept of Oncology, Birmingham, , United Kingdom
University College London Hospital, London, , United Kingdom
Guys & St Thomas Hospital; Department of Oncology, London, , United Kingdom
Contact Details
Name: Clinical Trials
Affiliation: Hoffmann-La Roche
Role: STUDY_DIRECTOR
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