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
PROFILE 1014
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.
3 other identifiers
interventional
343
30 countries
248
Brief Summary
This study will evaluate the anti-cancer effects of crizotinib when compared with standard chemotherapy in patients with ALK positive lung cancer.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Jan 2011
Longer than P75 for phase_3
248 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 29, 2010
CompletedFirst Posted
Study publicly available on registry
June 30, 2010
CompletedStudy Start
First participant enrolled
January 13, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 30, 2013
CompletedResults Posted
Study results publicly available
January 5, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
November 30, 2016
CompletedNovember 6, 2017
September 1, 2017
2.9 years
June 29, 2010
November 26, 2014
September 29, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Progression-Free Survival (PFS) Based on IRR
PFS was defined as the time from the date of randomization in study until the date of first documented objective tumor progression (according to RECIST v1.1 as determined by IRR) or death (due to any cause), whichever occurred first. PFS (in months) was calculated as (first event date - randomization date +1)/30.44. Objective progression was defined as a 20 percent (%) increase in the sum of the diameters of target measurable lesions taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study), with a minimum absolute increase of 5 millimeter (mm) or clear progression of pre-existing non-target lesions, or the appearance of any new clear lesions.
Randomization to objective progression, death or last tumor assessment without progression before any additional anti-cancer therapy (up to 35 months)
Secondary Outcomes (23)
Overall Survival (OS)
From randomization to death or last date known alive for those not known to have died (up to 72 months)
Overall Survival Probability at Month 12 and 18
Month 12, 18
Objective Response Rate (ORR): Percentage of Participants With Objective Response as Assessed by IRR
Randomization to objective progression, death or last tumor assessment without progression before any additional anti-cancer therapy (up to 35 months)
Duration of Response (DR) Based on IRR
From objective response to date of progression, death or last tumor assessment without progression before any additional anti-cancer therapy (up to 35 months)
Time to Tumor Response (TTR) Based on IRR
Randomization to first documentation of objective tumor response (up to 35 months)
- +18 more secondary outcomes
Study Arms (2)
A
EXPERIMENTALB
ACTIVE COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- Proven diagnosis of locally advanced not suitable for local treatment, recurrent and metastatic non-squamous cell carcinoma of the lung
- Positive for translocation or inversion events involving the ALK gene locus
- No prior systemic treatment for locally advanced or metastatic disease; Patients with brain metastases only if treated and neurologically stable with no ongoing requirement for corticosteroids
- Evidence of a personally signed and dated informed consent document and willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures including completion of patient reported outcome \[PRO\] measures.
- years of age or older with the exception of India which has an upper age limit of 65 years old
You may not qualify if:
- Current treatment on another therapeutic clinical trial.
- Prior therapy directly targeting ALK.
- Any of the following within the 3 months prior to starting study treatment: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, congestive heart failure, or cerebrovascular accident including transient ischemic attack. - - Appropriate treatment with anticoagulants is permitted.
- Ongoing cardiac dysrhythmias of NCI CTCAE Grade \>=2, uncontrolled atrial fibrillation of any grade, or QTc interval \>470 msec.
- Pregnancy or breastfeeding.
- Use of drugs or foods that are known potent CYP3A4 inducers/inhibitors Concurrent use of drugs that are CYP3A4 substrates with narrow therapeutic indices.
- Known HIV infection
- Known interstitial lung disease or interstitial fibrosis
- Other severe acute or chronic medical conditions (including severe gastrointestinal conditions such as diarrhea or ulcer) or psychiatric conditions, or laboratory abnormalities that would impart, in the judgment of the investigator and/or sponsor, excess risk associated with study participation or study drug administration, and which would, therefore, make the patient inappropriate for entry into this study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (249)
Tower Cancer Research Foundation
Beverly Hills, California, 90211-1850, United States
Tower Hematology Oncology Medical Group
Beverly Hills, California, 90211-1850, United States
CCTAP
Fontana, California, 92335, United States
Loma Linda University Cancer Center
Loma Linda, California, 92350, United States
Loma Linda University Cancer Center (LLUCC)-Schuman Pavilion
Loma Linda, California, 92354, United States
Loma Linda University Medical Center
Loma Linda, California, 92354, United States
CCTAP
Los Angeles, California, 90027, United States
Kaiser Permanente Southern California
San Diego, California, 92108, United States
CCTAP
San Diego, California, 92120, United States
Georgetown University Hospital
Washington D.C., District of Columbia, 20007, United States
Research Pharmacy, Georgetown University Medical Center
Washington D.C., District of Columbia, 20007, United States
Lynn Cancer Institute Center for Hematology Oncology
Boca Raton, Florida, 33486, United States
Florida Hospital
Orlando, Florida, 32803, United States
Cancer Institute of Florida
Orlando, Florida, 32804, United States
Investigational Drug Services
Orlando, Florida, 32804, United States
Georgia Cancer Specialists
Athens, Georgia, 30606, United States
Georgia Cancer Specialists
Atlanta, Georgia, 30341, United States
Georgia Cancer Specialists
Decatur, Georgia, 30033, United States
Georgia Cancer Specialists
Macon, Georgia, 31217, United States
Georgia Cancer Specialists
Marietta, Georgia, 30060, United States
Georgia Cancer Specialists
Sandy Springs, Georgia, 30342, United States
University of Chicago
Chicago, Illinois, 60637, United States
Al Fisher, Pharm D.
Harvey, Illinois, 60426, United States
Ingalls Memorial Hospital
Harvey, Illinois, 60426, United States
Monroe Medical Associates
Harvey, Illinois, 60426, United States
Monroe Medical Associates
Tinley Park, Illinois, 60477, United States
Indiana University Hospital
Indianapolis, Indiana, 46202, United States
Indiana University Melvin and Bren Simon Cancer Center
Indianapolis, Indiana, 46202, United States
Lois and Eskenazi Hospital
Indianapolis, Indiana, 46202, United States
Monroe Medical Association
Munster, Indiana, 46321, United States
The Community Hospital
Munster, Indiana, 46321, United States
Ochsner Clinic Foundation
New Orleans, Louisiana, 70121, United States
Maine Center for Cancer Medicine
Biddeford, Maine, 04005, United States
Maine Center for Cancer Medicine
Brunswick, Maine, 04011, United States
Maine Center for Cancer Medicine
Sanford, Maine, 04073, United States
Maine Center for Cancer Medicine
Scarborough, Maine, 04074, United States
Kresge Eye Institute
Bingham Farms, Michigan, 48025, United States
Karmanos Cancer Institute
Detroit, Michigan, 48201, United States
Kresge Eye Institute
Detroit, Michigan, 48201, United States
Karmanos Cancer Institute at Farmington Hills
Farmington Hills, Michigan, 48334, United States
Siteman Cancer Center
City of Saint Peters, Missouri, 63376, United States
Siteman Cancer Center - West County
Creve Coeur, Missouri, 63141, United States
Barnes-Jewish Hospital
St Louis, Missouri, 63110-1094, United States
Washington University Center for Advanced Medicine Infusion Center Pharmacy
St Louis, Missouri, 63110, United States
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, 03756-0001, United States
Hematology-Oncology Associates of Northern New Jersey
Morristown, New Jersey, 07962, United States
University of New Mexico Cancer Center
Albuquerque, New Mexico, 87106, United States
UNM Eye Clinic
Albuquerque, New Mexico, 87106, United States
Memorial Medical Center
Las Cruces, New Mexico, 88011, United States
NSLIJ Health System/Monter Cancer Center
Lake Success, New York, 11042, United States
North Shore University Hospital
Manhasset, New York, 11030, United States
Long Island Jewish Medical Center
New Hyde Park, New York, 11040, United States
SUNY Upstate Medical University
Syracuse, New York, 13210, United States
OHSU Knight Cancer Institute
Beaverton, Oregon, 97006, United States
OHSU Knight Cancer Institute
Gresham, Oregon, 97030, United States
OHSU Knight Cancer Institute
Portland, Oregon, 97210, United States
OHSU Knight Cancer Institute
Portland, Oregon, 97216, United States
Oregon Health and Science University
Portland, Oregon, 97239, United States
OHSU Knight Cancer Institute
Tualatin, Oregon, 97062, United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111, United States
Vincent Armenio
East Providence, Rhode Island, 02914, United States
Pharma Resource
East Providence, Rhode Island, 02915, United States
Tennessee Oncology, PLLC
Dickson, Tennessee, 37055, United States
Tennessee Oncology, PLLC
Franklin, Tennessee, 37067, United States
Tennessee Oncology, PLLC
Gallatin, Tennessee, 37066, United States
Tennessee Oncology, PLLC
Hermitage, Tennessee, 37076, United States
Tennessee Oncology, PLLC
Lebanon, Tennessee, 37087, United States
Tennessee Oncology, PLLC
Murfreesboro, Tennessee, 37130, United States
Sarah Cannon Research Institute
Nashville, Tennessee, 37203, United States
Tennessee Oncology, PLLC
Nashville, Tennessee, 37203, United States
Tennessee Oncology, PLLC
Nashville, Tennessee, 37205, United States
Tennessee Oncology, PLLC
Nashville, Tennessee, 37207, United States
Tennessee Oncology, PLLC
Nashville, Tennessee, 37211, United States
Henry-Joyce Cancer Clinic
Nashville, Tennessee, 37232-5536, United States
Vanderbilt Oncology Pharmacy
Nashville, Tennessee, 37232-7610, United States
Tennessee Oncology, PLLC
Smyrna, Tennessee, 37167, United States
UT Southwestern Medical Center - Simmons Cancer Center Pharmacy
Dallas, Texas, 75390-9015, United States
UT Southwestern Medical Center
Dallas, Texas, 75390, United States
UT Southwestern University Hospital - William P. Clements, Jr.
Dallas, Texas, 75390, United States
UT Southwestern University Hospital - Zale Lipshy
Dallas, Texas, 75390, United States
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030, United States
Seattle Cancer Care Alliance
Seattle, Washington, 98109, United States
University of Washington Medical Center
Seattle, Washington, 98195, United States
University of Wisconsin Hospital and Clinics
Madison, Wisconsin, 53792-5666, United States
Macarthur Cancer Therapy Centre
Campbelltown, New South Wales, 2560, Australia
Chris O'Brien Lifehouse
Camperdown, New South Wales, 2050, Australia
Royal North Shore Hospital
St Leonards, New South Wales, 2065, Australia
The Prince Charles Hospital
Chermside, Queensland, 4032, Australia
The Townsville Hospital
Douglas, Queensland, 4814, Australia
The Royal Brisbane & Womens Hospital
Herston, Queensland, 4006, Australia
Parkhaven Medical Center
Hyde Park, Queensland, 4812, Australia
Department of Medical Oncology
Adelaide, South Australia, 5000, Australia
Peter MacCallum Cancer Centre, Department of Haematology and Medical Oncology
East Melbourne, Victoria, 3002, Australia
Peninsula & South Eastern Haematology and Oncology Group
Frankston, Victoria, 3199, Australia
Klinikum Wels-Grieskirchen
Wels, 4600, Austria
UZ Antwerpen-Pneumologie
Edegem, Antwerp, 2650, Belgium
Grand Hopital de Charleroi -Site Notre Dame
Charleroi, Hainaut, 6000, Belgium
Institut Jules Bordet, Centre des Tumeurs de l'ULB
Brussels, 1000, Belgium
Universitair Ziekenhuis Brussel / Medische Oncologie
Brussels, 1090, Belgium
Cliniques Universitaires St Luc
Brussels, 1200, Belgium
Universitair Ziekenhuis Gent (U.Z. Gent)
Ghent, 9000, Belgium
Centre Hospitalier Universitaire de Liege
Liège, 4000, Belgium
Department of Pulmonary Diseases AZ Delta
Roeselare, 8800, Belgium
Instituto Nacional de Cancer - INCA
Rio de Janeiro, Rio de Janeiro, 20231 -050, Brazil
Associacao Hospital de Caridade de Ijui
Ijuí, Rio Grande do Sul, 98700-000, Brazil
Hospital Sao Lucas da PUCRS
Porto Alegre, Rio Grande do Sul, 90610-000, Brazil
Fundacao Pio XII Hospital de Cancer de Barretos
Barretos, São Paulo, 14784-400, Brazil
Instituto do Câncer do Estado de São Paulo Octavio Frias de Oliveira - ICESP
São Paulo, São Paulo, 01246-000, Brazil
Cross Cancer Institute
Edmonton, Alberta, T6G 1Z2, Canada
QEII Health Sciences Centre
Halifax, Nova Scotia, B2H 2Y9, Canada
QEII Health Sciences Centre
Halifax, Nova Scotia, B3H 1V7, Canada
R.S. McLaughlin Durham Regional Cancer Centre
Oshawa, Ontario, L1G 2B9, Canada
Jewish General Hospital
Montreal, Quebec, H3T 1E2, Canada
McGill University Health Centre (MUHC), Glen Site, Cedars Cancer Centre
Montreal, Quebec, H4A 3J1, Canada
Institut universitaire de cardiologie et de pneumologie de Quebec (IUCPQ)
Ste-Foy, Quebec, G1V 4G5, Canada
Instituto Clinico Oncologico del Sur
Temuco, Cautin, 4810469, Chile
Instituto Nacional del Cancer
Santiago, RM, 8380455, Chile
Hospital Clinico Universidad de Chile, Seccion de Oncologia
Independencia, Santiago, Rm, 8380456, Chile
307 Hospital of PLA
Beijing, Beijing Municipality, 100071, China
Oncology Center, Guangdong General Hospital
Guangzhou, Guangdong, 510080, China
Union Hospital, Tongji Medical College of Huazhong University of Science & Technology/Cancer Center
Wuhan, Hubei, 430023, China
No.81 Hospital of the PLA
Nanjing, Jiangsu, 210002, China
Oncology Department, West China Hospital of Sichuan University
Chengdu, Sichuan, 610041, China
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Beijing, 100021, China
Shanghai Chest Hospital/Department of Pulmonary Medicine
Shanghai, 200030, China
Zhongshan Hospital Fudan University
Shanghai, 200030, China
Shanghai Pulmonary Hospital/Dept. of Oncology
Shanghai, 200433, China
Helsingin yliopistollinen keskussairaala, Meilahden kolmiosairaala,Keuhkosairauksien poliklinikka
Helsinki, 00290, Finland
Satakunnan keskussairaala/Keuhkosairauksien osasto A4
Pori, 28500, Finland
Tampereen yliopistollinen sairaala
Tampere, 33520, Finland
Hopital Avicenne
Bobigny, 93009, France
CHU de Caen
Caen, 14033, France
CHU Grenoble
Grenoble, 38043, France
Centre Oscar Lambret
Lille, 59020, France
Centre Leon Berard
Lyon, 69373, France
APHM - Hopital Nord / Service d'Oncologie Multidisciplinaire et Innovations Thérapeutiques
Marseille, 13915, France
Hopital Arnaud de Villeneuve / CHU de Montpellier
Montpellier, 34295, France
Hopital Tenon, Service de Pneumologie
Paris, 75970, France
Nouvel Hopital Civil - HSU - Pôle de Pathologie Thoracique - Service de Pneumologie
Strasbourg, 67091, France
Zentralklinik Bad Berka GmbH
Bad Berka, 99437, Germany
Charite - Universitaetsmedizin Berlin, Campus Mitte
Berlin, 10117, Germany
Thoraxklinik am Universitaetsklinikum Heidelberg
Heidelberg, 69126, Germany
St.Vincentius-Kliniken Karlsruhe
Karlsruhe, 76137, Germany
UNIVERSITÄTSMEDIZIN der Johannes Gutenberg-Universität Mainz
Mainz, 55131, Germany
Kliniken Maria Hilf GmbH
Mönchengladbach, 41063, Germany
Pius-Hospital Oldenburg
Oldenburg, 26121, Germany
HSK Dr.- Horst-Schmidt-Kliniken GmbH,
Wiesbaden, 65199, 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, 380 016, India
Tata Memorial Centre, Tata Memorial Hospital,
Mumbai, Maharashtra, 400012, India
Aseptic Compounding Unit
Dublin, Dublin 8, Ireland
Department of Medical Oncology
Dublin, Dublin 8, Ireland
Struttura Operativa Complessa Oncologia Medica A Centro di Riferimento Oncologico
Aviano, Pordenone, 33081, Italy
Farmacia
Aviano (PN), 33081, Italy
Istituto dei tumori Giovanni Paolo II
Bari, 70124, Italy
Unità Operativa di Oncologia Medica Azienda USL Città di Bologna
Bologna, 40100, Italy
Azienda Ospedaliero-Universitaria "Mater Domini"
Catanzaro, 88100, Italy
Unità Operativa di Farmacia - Campus Salvatore venuta
Catanzaro, 88100, Italy
Ospedale Civile Azienda USL Toscana Nord Ovest
Livorno, 57124, Italy
Unità Operativa Farmacia Ospedaliera PO di Livorno
Livorno, 57124, Italy
Fondazione IRCCS Istituto Nazionale Tumori, Struttura Complessa di Medicina Oncologica 1
Milan, 20133, Italy
Farmacia Istituto Europeo di Oncologia IRCCS, U.O. Farmacia
Milan, 20141, Italy
Istituto Europeo di Oncologia
Milan, 20141, Italy
Ospedale Niguarda Ca'Granda, Divisione Oncologia Medica Falck
Milan, 20162, Italy
A.O.R.N. Ospedale Dei Colli - Monaldi
Napoli, 80131, Italy
Farmacia
Napoli, 80131, Italy
Azienda Ospedaliera Universitaria San Luigi Gonzaga
Orbassano (TO), 10043, Italy
S.C. Farmacia Ospedaliera , Azienda Ospedaliero Universitaria San Luigi Gonzaga
Orbassano (TO), 10043, Italy
Oncologia Medica, Azienda Ospedaliero- Universitaria di Parma
Parma, 43126, Italy
Farmacia Ospedaliera
Perugia, 06132, Italy
SC Oncologia Medica, Ospedale Santa Maria della Misericordia
Perugia, 06132, Italy
IRCCS -Arcispedale S. Maria Nuova Tecnologie Avanzate e Modelli Assistenziali in Oncologia
Reggio Emilia, 42123, Italy
Istituto Regina Elena, Struttura Complessa Oncologia Medica A
Roma, 00144, Italy
Azienda Ospedaliera San Camillo Forlanini-Padiglione Flaiani
Roma, 00152, Italy
Farmacia Interna
Roma, 00152, Italy
Unita Operativa, Oncologia Medica, Istituto di Medicina Interna e Geriatria
Roma, 00168, Italy
Aichi cancer center central hospital
Nagoya, Aichi-ken, 464-8681, Japan
National Cancer Center Hospital East
Kashiwa, Chiba, 277-8577, Japan
National Hospital Organization Shikoku Cancer Center
Matsuyama, Ehime, 791-0280, Japan
National Hospital Organization Hokkaido Cancer Center
Sapporo, Hokkaido, 003-0804, Japan
Hyogo Cancer Center
Akashi, Hyōgo, 673-8558, Japan
Kanagawa Cardiovascular and Respiratory Center
Yokohama, Kanagawa, 236-0051, Japan
Tohoku University Hospital
Sendai, Miyagi, 980-8574, Japan
Okayama University Hospital
Okayama, Okayama-ken, 700-8558, Japan
Kinki University Hospital
Osakasayama-shi, Osaka, 589-8511, Japan
Shizuoka Cancer Center
Sunto-gun, Shizuoka, 411-8777, Japan
National Cancer Center Hospital
Chuo-Ku, Tokyo, 104-0045, Japan
The Cancer Institute Hospital of JFCR
Koto-ku, Tokyo, 135-8550, Japan
National Hospital Organization Yamaguchi-Ube Medical Center
Ube-shi, Yamaguchi, 755-0241, Japan
National Hospital organization Kyushu Cancer Center
Fukuoka, 811-1395, Japan
Kyushu University Hospital Respiratory Medicine
Fukuoka, 812-8582, Japan
Centre Hospitalier de Luxembourg
Luxembourg, 1210, Luxembourg
Instituto Nacional de Cancerologia
México, D.f., 14080, Mexico
Jeroen Bosch Ziekenhuis
's-Hertogenbosch, North Brabant, 5223 GZ, Netherlands
VUMC
Amsterdam, 1081 HV, Netherlands
Academisch Ziekenhuis Maastricht / afdeling longziekten en tuberculose
Maastricht, 6229 HX, Netherlands
Oslo universitetssykehus HF - Radiumhospitalet
Oslo, 0424, Norway
Clinica Anglo Americana/Centro de Investigacion Oncologia CAA
San Isidro, Lima region, 27, Peru
Centro Hospitalar e Universitario de Coimbra - Hospital Geral
Coimbra, 3041-801, Portugal
Instituto Português de Oncologia de Lisboa, Prof. Francisco Gentil E.P.E.
Lisbon, 1099-023, Portugal
Centro Hospitalar de Lisboa Norte - Hospital Pulido Valente
Lisbon, 1769-001, Portugal
Centro Hospitalar de Vila Nova de Gaia/Espinho, E.P.E.
Vila Nova de Gaia, 4434-502, Portugal
Russian Oncological Research Center N.N. Blokhin
Moscow, 115478, Russia
City Clinical Oncology Dispensary
Saint Petersburg, 197022, Russia
First Saint-Petersburg State Medical University n.a. I.P. Pavlov
Saint Petersburg, 197022, Russia
First Saint-Petersburg State Medical University n.a. I.P.
Saint Petersburg, 197101, Russia
Russian Scientific Center of Radiology and Surgical Technologies
Saint Petersburg, 197758, Russia
City Clinical Oncology Dispensary
Saint Petersburg, 198255, Russia
Samara Regional Clinical Oncology Dispensary
Samara, 443031, Russia
National University Hospital
Singapore, 119074, Singapore
National Cancer Centre
Singapore, 169610, Singapore
Parkway Cancer Centre
Singapore, 228510, Singapore
OncoCare Cancer Centre
Singapore, 258499, Singapore
University of Witwatersrand Oncology
Johannesburg, Gauteng, 2193, South Africa
Rondebosch Oncology Centre, Rondebosch Medical Centre
Cape Town, 7700, South Africa
Seoul National University Hospital
Seoul, 03080, South Korea
Asan Medical Center
Seoul, 05505, South Korea
Samsung Medical Center, Sungkyunkwan Univ. School of Medicine
Seoul, 06351, South Korea
Hospital General Universitario de Elche
Elche, Alicante, 03203, Spain
Hospital Universitario Virgen Macarena
Seville, Andalusia, 41009, Spain
Hospital Clinico Universitario Lozano Blesa
Zaragoza, Aragon, 50009, Spain
Hospital Clinic I Provincial de Barcelona
Barcelona, Catalonia, 08036, Spain
Hospital Universitari Vall D'Hebron
Barcelona, 08035, Spain
Hospital Universitario Insular de Gran Canaria
Las Palmas de Gran Canaria, 35016, Spain
Hospital Ramon Y Cajal
Madrid, 28034, Spain
Hospital Doce de Octubre
Madrid, 28041, Spain
Hospital Universitario Virgen de La Victoria
Málaga, 29010, Spain
Universitaetsspital Basel
Basel, CH-4031, Switzerland
Luzerner Kantonsspital (LUKS)
Lucerne, 6000, Switzerland
Kantonsspital Winterthur
Winterthur, CH-8401, Switzerland
Chang Gung Medical Foundation, Kaohsiung Branch
Kaohsiung City, 833, Taiwan
China Medical University Hospital
Taichung, 404, Taiwan
Taichung Veterans General Hospital, Comprehensive Cancer Center
Taichung, 40705, Taiwan
Chang Gung Medical Foundation, LinKou Branch
Taoyuan District, 33305, Taiwan
City Multiple-Discipline Clinical Hospital #4,
Dnipropetrovsk, 49102, Ukraine
City Multiple-Discipline Clinical Hospital #4
Dnipropetrovsk, 49102, Ukraine
Department of Oncology and Medical Radiology, SI "DMA of MOH, Ukraine
Dnipropetrovsk, 49102, Ukraine
Kyiv City Clinical Oncologic Center/Department of Chemotherapy
Kyiv, 03115, Ukraine
Lviv State Oncologic Regional Treatment and Diagnostic Center
Lviv, 79031, Ukraine
Addenbrooke's Hospital, Oncology Centre
Cambridge, Cambridgeshire, CB2 0QQ, United Kingdom
Lister Hospital
Stevenage, Hertfordshire, SG1 4AB, United Kingdom
Queen Elizabeth II Hospital
Welwyn Garden City, Hertfordshire, AL7 4HQ, United Kingdom
Spire Manchester Hospital
Manchester, Lancashire, M16 8AJ, United Kingdom
Mount Vernon Hospital, Mount Vernon Cancer Centre
Northwood, Middlesex, HA6 2RN, United Kingdom
NHS Greater Glasgow and Clyde Health Board, Beatson West of Scotland Cancer Centre,
Glasgow, Scotland, G12 0YN, United Kingdom
Ross Hall Hospital
Glasgow, Scotland, G52 3NQ, United Kingdom
Aberdeen Royal Infirmary
Aberdeen, AB25 2ZN, United Kingdom
The Christie Hospital NHS Foundation Trust, Department of Medical Oncology
Manchester, M20 4BX, United Kingdom
Related Publications (7)
Camidge DR, Kim EE, Usari T, Polli A, Lewis I, Wilner KD. Renal Effects of Crizotinib in Patients With ALK-Positive Advanced NSCLC. J Thorac Oncol. 2019 Jun;14(6):1077-1085. doi: 10.1016/j.jtho.2019.02.015. Epub 2019 Feb 26.
PMID: 30822515DERIVEDWilner KD, Usari T, Polli A, Kim EE. Comparison of cardiovascular effects of crizotinib and chemotherapy in ALK-positive advanced non-small-cell lung cancer. Future Oncol. 2019 Apr;15(10):1097-1103. doi: 10.2217/fon-2018-0869. Epub 2019 Jan 17.
PMID: 30652510DERIVEDSolomon BJ, Kim DW, Wu YL, Nakagawa K, Mekhail T, Felip E, Cappuzzo F, Paolini J, Usari T, Tang Y, Wilner KD, Blackhall F, Mok TS. Final Overall Survival Analysis From a Study Comparing First-Line Crizotinib Versus Chemotherapy in ALK-Mutation-Positive Non-Small-Cell Lung Cancer. J Clin Oncol. 2018 Aug 1;36(22):2251-2258. doi: 10.1200/JCO.2017.77.4794. Epub 2018 May 16.
PMID: 29768118DERIVEDYoneda KY, Scranton JR, Cadogan MA, Tassell V, Nadanaciva S, Wilner KD, Stollenwerk NS. Interstitial Lung Disease Associated With Crizotinib in Patients With Advanced Non-Small Cell Lung Cancer: Independent Review of Four PROFILE Trials. Clin Lung Cancer. 2017 Sep;18(5):472-479. doi: 10.1016/j.cllc.2017.03.004. Epub 2017 Mar 14.
PMID: 28373069DERIVEDSolomon BJ, Cappuzzo F, Felip E, Blackhall FH, Costa DB, Kim DW, Nakagawa K, Wu YL, Mekhail T, Paolini J, Tursi J, Usari T, Wilner KD, Selaru P, Mok TS. Intracranial Efficacy of Crizotinib Versus Chemotherapy in Patients With Advanced ALK-Positive Non-Small-Cell Lung Cancer: Results From PROFILE 1014. J Clin Oncol. 2016 Aug 20;34(24):2858-65. doi: 10.1200/JCO.2015.63.5888. Epub 2016 Mar 28.
PMID: 27022118DERIVEDSolomon BJ, Mok T, Kim DW, Wu YL, Nakagawa K, Mekhail T, Felip E, Cappuzzo F, Paolini J, Usari T, Iyer S, Reisman A, Wilner KD, Tursi J, Blackhall F; PROFILE 1014 Investigators. First-line crizotinib versus chemotherapy in ALK-positive lung cancer. N Engl J Med. 2014 Dec 4;371(23):2167-77. doi: 10.1056/NEJMoa1408440.
PMID: 25470694DERIVEDOu SH. Crizotinib: a drug that crystallizes a unique molecular subset of non-small-cell lung cancer. Expert Rev Anticancer Ther. 2012 Feb;12(2):151-62. doi: 10.1586/era.11.186.
PMID: 22316363DERIVED
Related Links
MeSH Terms
Interventions
Results Point of Contact
- Title
- Pfizer ClinicalTrials.gov Call Center
- Organization
- Pfizer, Inc.
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 29, 2010
First Posted
June 30, 2010
Study Start
January 13, 2011
Primary Completion
November 30, 2013
Study Completion
November 30, 2016
Last Updated
November 6, 2017
Results First Posted
January 5, 2015
Record last verified: 2017-09