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Brief Title: A Clinical Trial Testing The Efficacy Of Crizotinib Versus Standard Chemotherapy Pemetrexed Plus Cisplatin Or Carboplatin In Patients With ALK Positive Non Squamous Cancer Of The Lung
Official Title: Phase 3, Randomized, Open-label Study Of The Efficacy And Safety Of Crizotinib Versus Pemetrexed/Cisplatin Or Pemetrexed/Carboplatin In Previously Untreated Patients With Non-squamous Carcinoma Of The Lung Harboring A Translocation Or Inversion Event Involving The Anaplastic Lymphoma Kinase (Alk) Gene Locus.
Study ID: NCT01154140
Brief Summary: This study will evaluate the anti-cancer effects of crizotinib when compared with standard chemotherapy in patients with ALK positive lung cancer.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Tower Cancer Research Foundation, Beverly Hills, California, United States
Tower Hematology Oncology Medical Group, Beverly Hills, California, United States
CCTAP, Fontana, California, United States
Loma Linda University Cancer Center, Loma Linda, California, United States
Loma Linda University Cancer Center (LLUCC)-Schuman Pavilion, Loma Linda, California, United States
Loma Linda University Medical Center, Loma Linda, California, United States
CCTAP, Los Angeles, California, United States
Kaiser Permanente Southern California, San Diego, California, United States
CCTAP, San Diego, California, United States
Georgetown University Hospital, Washington, D.C., District of Columbia, United States
Research Pharmacy, Georgetown University Medical Center, Washington, D.C., District of Columbia, United States
Lynn Cancer Institute Center for Hematology Oncology, Boca Raton, Florida, United States
Florida Hospital, Orlando, Florida, United States
Cancer Institute of Florida, Orlando, Florida, United States
Investigational Drug Services, Orlando, Florida, United States
Georgia Cancer Specialists, Athens, Georgia, United States
Georgia Cancer Specialists, Atlanta, Georgia, United States
Georgia Cancer Specialists, Decatur, Georgia, United States
Georgia Cancer Specialists, Macon, Georgia, United States
Georgia Cancer Specialists, Marietta, Georgia, United States
Georgia Cancer Specialists, Sandy Springs, Georgia, United States
University of Chicago, Chicago, Illinois, United States
Al Fisher, Pharm D., Harvey, Illinois, United States
Ingalls Memorial Hospital, Harvey, Illinois, United States
Monroe Medical Associates, Harvey, Illinois, United States
Monroe Medical Associates, Tinley Park, Illinois, United States
Indiana University Hospital, Indianapolis, Indiana, United States
Indiana University Melvin and Bren Simon Cancer Center, Indianapolis, Indiana, United States
Lois and Eskenazi Hospital, Indianapolis, Indiana, United States
Monroe Medical Association, Munster, Indiana, United States
The Community Hospital, Munster, Indiana, United States
Ochsner Clinic Foundation, New Orleans, Louisiana, United States
Maine Center for Cancer Medicine, Biddeford, Maine, United States
Maine Center for Cancer Medicine, Brunswick, Maine, United States
Maine Center for Cancer Medicine, Sanford, Maine, United States
Maine Center for Cancer Medicine, Scarborough, Maine, United States
Kresge Eye Institute, Bingham Farms, Michigan, United States
Karmanos Cancer Institute, Detroit, Michigan, United States
Kresge Eye Institute, Detroit, Michigan, United States
Karmanos Cancer Institute at Farmington Hills, Farmington Hills, Michigan, United States
Siteman Cancer Center - West County, Creve Coeur, Missouri, United States
Barnes-Jewish Hospital, Saint Louis, Missouri, United States
Washington University Center for Advanced Medicine Infusion Center Pharmacy, Saint Louis, Missouri, United States
Siteman Cancer Center, Saint Peters, Missouri, United States
Dartmouth Hitchcock Medical Center, Lebanon, New Hampshire, United States
Hematology-Oncology Associates of Northern New Jersey, Morristown, New Jersey, United States
University of New Mexico Cancer Center, Albuquerque, New Mexico, United States
UNM Eye Clinic, Albuquerque, New Mexico, United States
Memorial Medical Center, Las Cruces, New Mexico, United States
NSLIJ Health System/Monter Cancer Center, Lake Success, New York, United States
North Shore University Hospital, Manhasset, New York, United States
Long Island Jewish Medical Center, New Hyde Park, New York, United States
SUNY Upstate Medical University, Syracuse, New York, United States
OHSU Knight Cancer Institute, Beaverton, Oregon, United States
OHSU Knight Cancer Institute, Gresham, Oregon, United States
OHSU Knight Cancer Institute, Portland, Oregon, United States
OHSU Knight Cancer Institute, Portland, Oregon, United States
Oregon Health and Science University, Portland, Oregon, United States
OHSU Knight Cancer Institute, Tualatin, Oregon, United States
Fox Chase Cancer Center, Philadelphia, Pennsylvania, United States
Vincent Armenio, East Providence, Rhode Island, United States
Pharma Resource, East Providence, Rhode Island, United States
Tennessee Oncology, PLLC, Dickson, Tennessee, United States
Tennessee Oncology, PLLC, Franklin, Tennessee, United States
Tennessee Oncology, PLLC, Gallatin, Tennessee, United States
Tennessee Oncology, PLLC, Hermitage, Tennessee, United States
Tennessee Oncology, PLLC, Lebanon, Tennessee, United States
Tennessee Oncology, PLLC, Murfreesboro, Tennessee, United States
Sarah Cannon Research Institute, Nashville, Tennessee, United States
Tennessee Oncology, PLLC, Nashville, Tennessee, United States
Tennessee Oncology, PLLC, Nashville, Tennessee, United States
Tennessee Oncology, PLLC, Nashville, Tennessee, United States
Tennessee Oncology, PLLC, Nashville, Tennessee, United States
Henry-Joyce Cancer Clinic, Nashville, Tennessee, United States
Vanderbilt Oncology Pharmacy, Nashville, Tennessee, United States
Tennessee Oncology, PLLC, Smyrna, Tennessee, United States
UT Southwestern Medical Center - Simmons Cancer Center Pharmacy, Dallas, Texas, United States
UT Southwestern Medical Center, Dallas, Texas, United States
UT Southwestern University Hospital - William P. Clements, Jr., Dallas, Texas, United States
UT Southwestern University Hospital - Zale Lipshy, Dallas, Texas, United States
University of Texas MD Anderson Cancer Center, Houston, Texas, United States
Seattle Cancer Care Alliance, Seattle, Washington, United States
University of Washington Medical Center, Seattle, Washington, United States
University of Wisconsin Hospital and Clinics, Madison, Wisconsin, United States
Macarthur Cancer Therapy Centre, Campbelltown, New South Wales, Australia
Chris O'Brien Lifehouse, Camperdown, New South Wales, Australia
Royal North Shore Hospital, St. Leonards, New South Wales, Australia
The Prince Charles Hospital, Chermside, Queensland, Australia
The Townsville Hospital, Douglas, Queensland, Australia
The Royal Brisbane & Womens Hospital, Herston, Queensland, Australia
Parkhaven Medical Center, Hyde Park, Queensland, Australia
Department of Medical Oncology, Adelaide, South Australia, Australia
Peter MacCallum Cancer Centre, Department of Haematology and Medical Oncology, East Melbourne, Victoria, Australia
Peninsula & South Eastern Haematology and Oncology Group, Frankston, Victoria, Australia
Klinikum Wels-Grieskirchen, Wels, , Austria
UZ Antwerpen-Pneumologie, Edegem, Antwerp, Belgium
Grand Hopital de Charleroi -Site Notre Dame, Charleroi, Hainaut, Belgium
Cliniques Universitaires St Luc, Brussels, , Belgium
Universitair Ziekenhuis Brussel / Medische Oncologie, Brussel, , Belgium
Institut Jules Bordet, Centre des Tumeurs de l'ULB, Bruxelles, , Belgium
Universitair Ziekenhuis Gent (U.Z. Gent), Gent, , Belgium
Centre Hospitalier Universitaire de Liege, Liege, , Belgium
Department of Pulmonary Diseases AZ Delta, Roeselare, , Belgium
Instituto Nacional de Cancer - INCA, Rio de Janeiro, RJ, Brazil
Associacao Hospital de Caridade de Ijui, Ijui, RS, Brazil
Hospital Sao Lucas da PUCRS, Porto Alegre, RS, Brazil
Instituto do Câncer do Estado de São Paulo Octavio Frias de Oliveira - ICESP, Sao Paulo, SP, Brazil
Fundacao Pio XII Hospital de Cancer de Barretos, Barretos, São Paulo, Brazil
Cross Cancer Institute, Edmonton, Alberta, Canada
QEII Health Sciences Centre, Halifax, Nova Scotia, Canada
QEII Health Sciences Centre, Halifax, Nova Scotia, Canada
R.S. McLaughlin Durham Regional Cancer Centre, Oshawa, Ontario, Canada
Jewish General Hospital, Montreal, Quebec, Canada
McGill University Health Centre (MUHC), Glen Site, Cedars Cancer Centre, Montreal, Quebec, Canada
Institut universitaire de cardiologie et de pneumologie de Quebec (IUCPQ), Ste-Foy, Quebec, Canada
Instituto Clinico Oncologico del Sur, Temuco, Cautin, Chile
Instituto Nacional del Cancer, Santiago, RM, Chile
Hospital Clinico Universidad de Chile, Seccion de Oncologia, Independencia, Santiago, Rm, Chile
307 Hospital of PLA, Beijing, Beijing, China
Oncology Center, Guangdong General Hospital, Guangzhou, Guangdong, China
Union Hospital, Tongji Medical College of Huazhong University of Science & Technology/Cancer Center, Wuhan, Hubei, China
No.81 Hospital of the PLA, Nanjing, Jiangsu, China
Oncology Department, West China Hospital of Sichuan University, Chengdu, Sichuan, China
Cancer Institute and Hospital, Chinese Academy of Medical Sciences, Beijing, , China
Shanghai Chest Hospital/Department of Pulmonary Medicine, Shanghai, , China
Zhongshan Hospital Fudan University, Shanghai, , China
Shanghai Pulmonary Hospital/Dept. of Oncology, Shanghai, , China
Helsingin yliopistollinen keskussairaala, Meilahden kolmiosairaala,Keuhkosairauksien poliklinikka, Helsinki, , Finland
Satakunnan keskussairaala/Keuhkosairauksien osasto A4, Pori, , Finland
Tampereen yliopistollinen sairaala, Tampere, , Finland
Hopital Avicenne, Bobigny Cedex, , France
CHU de Caen, Caen Cedex, , France
CHU Grenoble, Grenoble Cedex, , France
Centre Oscar Lambret, Lille, , France
Centre Leon Berard, Lyon Cedex 08, , France
APHM - Hopital Nord / Service d'Oncologie Multidisciplinaire et Innovations Thérapeutiques, Marseille Cedex 20, , France
Hopital Arnaud de Villeneuve / CHU de Montpellier, Montpellier, , France
Hopital Tenon, Service de Pneumologie, Paris cedex 20, , France
Nouvel Hopital Civil - HSU - Pôle de Pathologie Thoracique - Service de Pneumologie, Strasbourg, , France
Zentralklinik Bad Berka GmbH, Bad Berka, , Germany
Charite - Universitaetsmedizin Berlin, Campus Mitte, Berlin, , Germany
Thoraxklinik am Universitaetsklinikum Heidelberg, Heidelberg, , Germany
St.Vincentius-Kliniken Karlsruhe, Karlsruhe, , Germany
UNIVERSITÄTSMEDIZIN der Johannes Gutenberg-Universität Mainz, Mainz, , Germany
Kliniken Maria Hilf GmbH, Moenchengladbach, , Germany
Pius-Hospital Oldenburg, Oldenburg, , Germany
HSK Dr.- Horst-Schmidt-Kliniken GmbH,, Wiesbaden, , Germany
Prince of Wales Hospital, Shatin, New Territories, Hong Kong
Department of Clinical Oncology, Queen Elizabeth Hospital, Kowloon, , Hong Kong
The Gujarat Cancer & Research Institute (M.P Shah Cancer Hospital),, Ahmedabad,, Gujarat, India
Tata Memorial Centre, Tata Memorial Hospital,, Mumbai, Maharashtra, India
Aseptic Compounding Unit, Dublin, , Ireland
Department of Medical Oncology, Dublin, , Ireland
Struttura Operativa Complessa Oncologia Medica A Centro di Riferimento Oncologico, Aviano, Pordenone, Italy
Farmacia, Aviano (PN), , Italy
Istituto dei tumori Giovanni Paolo II, Bari, , Italy
Unità Operativa di Oncologia Medica Azienda USL Città di Bologna, Bologna, , Italy
Azienda Ospedaliero-Universitaria "Mater Domini", Catanzaro, , Italy
Unità Operativa di Farmacia - Campus Salvatore venuta, Catanzaro, , Italy
Ospedale Civile Azienda USL Toscana Nord Ovest, Livorno, , Italy
Unità Operativa Farmacia Ospedaliera PO di Livorno, Livorno, , Italy
Fondazione IRCCS Istituto Nazionale Tumori, Struttura Complessa di Medicina Oncologica 1, Milano, , Italy
Farmacia Istituto Europeo di Oncologia IRCCS, U.O. Farmacia, Milano, , Italy
Istituto Europeo di Oncologia, Milano, , Italy
Ospedale Niguarda Ca'Granda, Divisione Oncologia Medica Falck, Milano, , Italy
A.O.R.N. Ospedale Dei Colli - Monaldi, Napoli, , Italy
Farmacia, Napoli, , Italy
Azienda Ospedaliera Universitaria San Luigi Gonzaga, Orbassano (TO), , Italy
S.C. Farmacia Ospedaliera , Azienda Ospedaliero Universitaria San Luigi Gonzaga, Orbassano (TO), , Italy
Oncologia Medica, Azienda Ospedaliero- Universitaria di Parma, Parma, , Italy
Farmacia Ospedaliera, Perugia, , Italy
SC Oncologia Medica, Ospedale Santa Maria della Misericordia, Perugia, , Italy
IRCCS -Arcispedale S. Maria Nuova Tecnologie Avanzate e Modelli Assistenziali in Oncologia, Reggio Emilia, , Italy
Istituto Regina Elena, Struttura Complessa Oncologia Medica A, Roma, , Italy
Azienda Ospedaliera San Camillo Forlanini-Padiglione Flaiani, Roma, , Italy
Farmacia Interna, Roma, , Italy
Unita Operativa, Oncologia Medica, Istituto di Medicina Interna e Geriatria, Roma, , Italy
Aichi cancer center central hospital, Nagoya, Aichi, Japan
National Cancer Center Hospital East, Kashiwa, Chiba, Japan
National Hospital Organization Shikoku Cancer Center, Matsuyama, Ehime, Japan
National Hospital Organization Hokkaido Cancer Center, Sapporo, Hokkaido, Japan
Hyogo Cancer Center, Akashi, Hyogo, Japan
Kanagawa Cardiovascular and Respiratory Center, Yokohama, Kanagawa, Japan
Tohoku University Hospital, Sendai, Miyagi, Japan
Okayama University Hospital, Okayama-city, Okayama, Japan
Kinki University Hospital, Osakasayama-shi, Osaka, Japan
Shizuoka Cancer Center, Sunto-gun, Shizuoka, Japan
National Cancer Center Hospital, Chuo-Ku, Tokyo, Japan
The Cancer Institute Hospital of JFCR, Koto-ku, Tokyo, Japan
National Hospital Organization Yamaguchi-Ube Medical Center, Ube-shi, Yamaguchi, Japan
National Hospital organization Kyushu Cancer Center, Fukuoka, , Japan
Kyushu University Hospital Respiratory Medicine, Fukuoka, , Japan
Seoul National University Hospital, Seoul, , Korea, Republic of
Asan Medical Center, Seoul, , Korea, Republic of
Samsung Medical Center, Sungkyunkwan Univ. School of Medicine, Seoul, , Korea, Republic of
Centre Hospitalier de Luxembourg, Luxembourg, , Luxembourg
Instituto Nacional de Cancerologia, Mexico, D.f., Mexico
Jeroen Bosch Ziekenhuis, 's Hertogenbosch, NB, Netherlands
VUMC, Amsterdam, , Netherlands
Academisch Ziekenhuis Maastricht / afdeling longziekten en tuberculose, Maastricht, , Netherlands
Oslo universitetssykehus HF - Radiumhospitalet, Oslo, , Norway
Clinica Anglo Americana/Centro de Investigacion Oncologia CAA, San Isidro, Lima, Peru
Centro Hospitalar e Universitario de Coimbra - Hospital Geral, Coimbra, , Portugal
Instituto Português de Oncologia de Lisboa, Prof. Francisco Gentil E.P.E., Lisboa, , Portugal
Centro Hospitalar de Lisboa Norte - Hospital Pulido Valente, Lisboa, , Portugal
Centro Hospitalar de Vila Nova de Gaia/Espinho, E.P.E., Vila Nova de Gaia, , Portugal
Russian Oncological Research Center N.N. Blokhin, Moscow, , Russian Federation
City Clinical Oncology Dispensary, Saint-Petersburg, , Russian Federation
First Saint-Petersburg State Medical University n.a. I.P. Pavlov, Saint-Petersburg, , Russian Federation
First Saint-Petersburg State Medical University n.a. I.P., Saint-Petersburg, , Russian Federation
Russian Scientific Center of Radiology and Surgical Technologies, Saint-Petersburg, , Russian Federation
City Clinical Oncology Dispensary, Saint-Petersburg, , Russian Federation
Samara Regional Clinical Oncology Dispensary, Samara, , Russian Federation
National University Hospital, Singapore, , Singapore
National Cancer Centre, Singapore, , Singapore
Parkway Cancer Centre, Singapore, , Singapore
OncoCare Cancer Centre, Singapore, , Singapore
University of Witwatersrand Oncology, Johannesburg, Gauteng, South Africa
Rondebosch Oncology Centre, Rondebosch Medical Centre, Cape Town, , South Africa
Hospital General Universitario de Elche, Elche, Alicante, Spain
Hospital Universitario Virgen Macarena, Sevilla, Andalucia, Spain
Hospital Clinico Universitario Lozano Blesa, Zaragoza, Aragon, Spain
Hospital Clinic I Provincial de Barcelona, Barcelona, Catalunya, Spain
Hospital Universitari Vall D'Hebron, Barcelona, , Spain
Hospital Universitario Insular de Gran Canaria, Las Palmas de Gran Canaria, , Spain
Hospital Ramon Y Cajal, Madrid, , Spain
Hospital Doce de Octubre, Madrid, , Spain
Hospital Universitario Virgen de La Victoria, Malaga, , Spain
Universitaetsspital Basel, Basel, , Switzerland
Luzerner Kantonsspital (LUKS), Luzern, , Switzerland
Kantonsspital Winterthur, Winterthur, , Switzerland
Chang Gung Medical Foundation, Kaohsiung Branch, Kaohsiung City, , Taiwan
China Medical University Hospital, Taichung, , Taiwan
Taichung Veterans General Hospital, Comprehensive Cancer Center, Taichung, , Taiwan
Chang Gung Medical Foundation, LinKou Branch, Taoyuan, , Taiwan
City Multiple-Discipline Clinical Hospital #4,, Dnipropetrovsk, , Ukraine
City Multiple-Discipline Clinical Hospital #4, Dnipropetrovsk, , Ukraine
Department of Oncology and Medical Radiology, SI "DMA of MOH, Ukraine, Dnipropetrovsk, , Ukraine
Kyiv City Clinical Oncologic Center/Department of Chemotherapy, Kyiv, , Ukraine
Lviv State Oncologic Regional Treatment and Diagnostic Center, Lviv, , Ukraine
Addenbrooke's Hospital, Oncology Centre, Cambridge, Cambridgeshire, United Kingdom
Lister Hospital, Stevenage, Hertfordshire, United Kingdom
Queen Elizabeth II Hospital, Welwyn Garden City, Hertfordshire, United Kingdom
Spire Manchester Hospital, Manchester, Lancashire, United Kingdom
Mount Vernon Hospital, Mount Vernon Cancer Centre, Northwood, Middlesex, United Kingdom
NHS Greater Glasgow and Clyde Health Board, Beatson West of Scotland Cancer Centre,, Glasgow, Scotland, United Kingdom
Ross Hall Hospital, Glasgow, Scotland, United Kingdom
Aberdeen Royal Infirmary, Aberdeen, , United Kingdom
The Christie Hospital NHS Foundation Trust, Department of Medical Oncology, Manchester, , United Kingdom
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