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)

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Pfizer
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01154140
First received: June 29, 2010
Last updated: August 1, 2014
Last verified: August 2014
  Purpose

This study will evaluate the anti-cancer effects of crizotinib when compared with standard chemotherapy in patients with ALK positive lung cancer.


Condition Intervention Phase
Non Squamous Lung Cancer
Drug: treatment
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Progression-Free Survival (PFS) [ Time Frame: 35 months ] [ Designated as safety issue: No ]
    The period from study entry until disease progression, death or date of last contact. Progression Free Survival [PFS] based on Response Evaluation Criterion in Solid Tumors [RECIST] version 1.1 (documented by independent radiology laboratory)


Secondary Outcome Measures:
  • Number of Participants With Objective Response. [ Time Frame: 35 months ] [ Designated as safety issue: No ]
    Number of participants with Objective Response Rate [ORR ] documented by independent radiology laboratory, and Duration of Response [DR], Time to Response [TTR], intra-cranial and extra-cranial Disease Control Rate [DCR]

  • Type, incidence, severity, seriousness and relationship to study medications of adverse events (AE) and any laboratory abnormalities [ Time Frame: 35 months ] [ Designated as safety issue: Yes ]
  • Plasma concentrations of crizotinib (including its active moieties, if appropriate) [ Time Frame: 35 months ] [ Designated as safety issue: No ]
  • Proportion of patients with each of the ALK fusion variants of the EML4-ALK fusion [ Time Frame: 35 months ] [ Designated as safety issue: No ]
  • Patient reported outcome measures of pain, dyspnea, or cough, disease/treatment-related symptoms, and general health status and Health Care Resource Utilization [HCRU] [ Time Frame: 35 months ] [ Designated as safety issue: No ]
  • Overall Survival [OS] at 12 months, 18 months and overall [ Time Frame: 35 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 334
Study Start Date: January 2011
Estimated Study Completion Date: February 2015
Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A Drug: treatment
crizotinib 250mg orally continuous twice daily dosing
Active Comparator: B Drug: treatment
pemetrexed 500mg/m2 IV day 1 plus cisplatin 75mg/m2 IV day 1 every 21 days OR pemetrexed 500mg/m2 IV day 1 plus carboplatin AUC 5 or 6 day 1 every 21 days investigator's choice

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.
  • 18 years of age or older with the exception of India which has an upper age limit of 65 years old

Exclusion Criteria:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01154140

Contacts
Contact: Pfizer CT.gov Call Center 1-800-718-1021

  Hide Study Locations
Locations
United States, California
CCTAP Active, not recruiting
Anaheim, California, United States, 92807
CCTAP Active, not recruiting
Baldwin Park, California, United States, 91706
CCTAP Active, not recruiting
Bellflower, California, United States, 90706
Tower Hematology Oncology Medical Group Terminated
Beverly Hills, California, United States, 90211-1850
Tower Cancer Research Foundation Terminated
Beverly Hills, California, United States, 90211-1850
CCTAP Active, not recruiting
Fontana, California, United States, 92335
CCTAP Active, not recruiting
Harbor City, California, United States, 90710
CCTAP Active, not recruiting
Irvine, California, United States, 92618
Loma Linda University Medical Center Pharmacy Active, not recruiting
Loma Linda, California, United States, 92354
Loma Linda University Medical Center Active, not recruiting
Loma Linda, California, United States, 92354
Records Management Only- Loma Linda Cancer Center Active, not recruiting
Loma Linda, California, United States, 92354
Loma Linda University Cancer Center-Schuman Pavilion Active, not recruiting
Loma Linda, California, United States, 92354
CCTAP Active, not recruiting
Los Angeles, California, United States, 90034
CCTAP Active, not recruiting
Los Angeles, California, United States, 90027
CCTAP Active, not recruiting
Panorama City, California, United States, 91402
CCTAP Active, not recruiting
Riverside, California, United States, 92505
Kaiser Permanente Southern California Active, not recruiting
San Diego, California, United States, 92108
CTTAP Active, not recruiting
San Diego, California, United States, 92120
CCTAP Active, not recruiting
San Marcos, California, United States, 92069
CCTAP Active, not recruiting
Woodland Hills, California, United States, 91367
United States, District of Columbia
Georgetown University Hospital Terminated
Washington, District of Columbia, United States, 20007
Drug Shipment Address and Pharmacist Designees: Terminated
Washington, District of Columbia, United States, 20007
United States, Florida
Lynn Cancer Institute Center for Hematology Oncology Terminated
Boca Raton, Florida, United States, 33486
Cancer Institute of Florida Active, not recruiting
Orlando, Florida, United States, 32804
Investigational Drug Services Active, not recruiting
Orlando, Florida, United States, 32804
Hematology and Oncology Consultants, PA Active, not recruiting
Orlando, Florida, United States, 32804
Florida Hospital Active, not recruiting
Orlando, Florida, United States, 32803
United States, Georgia
Georgia Cancer Specialists Completed
Athens, Georgia, United States, 30606
Georgia Cancer Specialists Completed
Atlanta, Georgia, United States, 30341
Georgia Cancer Specialists Completed
Decatur, Georgia, United States, 30033
Georgia Cancer Specialists Completed
Macon, Georgia, United States, 31217
Georgia Cancer Specialists Completed
Marietta, Georgia, United States, 30060
Georgia Cancer Specialists Completed
Sandy Springs, Georgia, United States, 30342
United States, Illinois
University of Chicago Completed
Chicago, Illinois, United States, 60637
Ingalls Memorial Hospital Terminated
Harvey, Illinois, United States, 60426
Monroe Medical Associates Terminated
Harvey, Illinois, United States, 60426
Ship Drug To: Al Fisher, Pharm D. Terminated
Harvey, Illinois, United States, 60426
Monroe Medical Associates Terminated
Tinley Park, Illinois, United States, 60477
United States, Indiana
Wishard Health Services Active, not recruiting
Indianapolis, Indiana, United States, 46202
Methodist Hospital Active, not recruiting
Indianapolis, Indiana, United States, 46206
Indiana University Hospital Active, not recruiting
Indianapolis, Indiana, United States, 46202
Indiana University Melvin and Bren Simon Cancer Center Active, not recruiting
Indianapolis, Indiana, United States, 46202
The Community Hospital Terminated
Munster, Indiana, United States, 46321
Monroe Medical Association Terminated
Munster, Indiana, United States, 46321
United States, Louisiana
Ochsner Clinic Foundation Terminated
New Orleans, Louisiana, United States, 70121
United States, Maine
Maine Center for Cancer Medicine Completed
Biddeford, Maine, United States, 04005
Maine Center for Cancer Medicine Completed
Brunswick, Maine, United States, 04011
Maine Center for Cancer Medicine Completed
Sanford, Maine, United States, 04073
Maine Center for Cancer Medicine Completed
Scarborough, Maine, United States, 04074
United States, Michigan
Karmanos Cancer Institute Active, not recruiting
Detroit, Michigan, United States, 48201
Karmanos Cancer Institute at Farmington Hills Active, not recruiting
Farmington Hills, Michigan, United States, 48334
United States, Missouri
Siteman Cancer Center - West County Recruiting
Creve Coeur, Missouri, United States, 63141
Washington University School of Medicine Recruiting
St. Louis, Missouri, United States, 63110-1094
Barnes-Jewish Hospital Recruiting
St. Louis, Missouri, United States, 63110-1094
Siteman Cancer Center Recruiting
St. Peters, Missouri, United States, 63376
United States, New Hampshire
Dartmouth Hitchcock Medical Center Terminated
Lebanon, New Hampshire, United States, 03756-0001
United States, New Jersey
Hematology-Oncology Associates of Northern New Jersey Terminated
Morristown, New Jersey, United States, 07962
United States, New Mexico
UNM Eye Clinic Completed
Albuquerque, New Mexico, United States, 87106
University of New Mexico Cancer Center Completed
Albuquerque, New Mexico, United States, 87106
Memorial Medical Center Completed
Las Cruces, New Mexico, United States, 88011
United States, New York
NSLIJ Health System/Monter Cancer Center Terminated
Lake Success, New York, United States, 11042
North Shore University Hospital Terminated
Manhasset, New York, United States, 11030
Long Island Jewish Medical Center Terminated
New Hyde Park, New York, United States, 11040
Department of Medicine MSG at SUNY HSC at Syracuse, Inc. Active, not recruiting
Oneida, New York, United States, 13421
Department of Medicine MSG at SUNY HSC at Syracuse, Inc. Active, not recruiting
Oswego, New York, United States, 13126
SUNY Upstate Medical University Active, not recruiting
Syracuse, New York, United States, 13210-2306
Department of Medicine MSG at SUNY HSC at Syracuse, Inc. Active, not recruiting
Syracuse, New York, United States, 13210
United States, Oregon
OHSU Knight Cancer Institute Terminated
Beaverton, Oregon, United States, 97006
OHSU Knight Cancer Institute Terminated
Gresham, Oregon, United States, 97030
Oregon Health and Science University Terminated
Portland, Oregon, United States, 97239
OHSU Knight Cancer Institute Terminated
Portland, Oregon, United States, 97216
OHSU Knight Cancer Institute Terminated
Portland, Oregon, United States, 97210
OHSU Knight Cancer Institute Terminated
Tualatin, Oregon, United States, 97062
United States, Pennsylvania
Fox Chase Cancer Center Terminated
Philadelphia, Pennsylvania, United States, 19111
United States, Rhode Island
Vincent Armenio Terminated
East Providence, Rhode Island, United States, 02914
Pharma Resource Terminated
East Providence, Rhode Island, United States, 02915
United States, Tennessee
Tennessee Oncology, PLLC Terminated
Dickson, Tennessee, United States, 37055
Tennessee Oncology, PLLC Terminated
Franklin, Tennessee, United States, 37067
Tennessee Oncology, PLLC Terminated
Gallatin, Tennessee, United States, 37066
Tennessee Oncology, PLLC Terminated
Hermitage, Tennessee, United States, 37076
Tennessee Oncology, PLLC Terminated
Lebanon, Tennessee, United States, 37087
Tennessee Oncology, PLLC Terminated
Murfreesboro, Tennessee, United States, 37130
Henry-Joyce Cancer Clinic Terminated
Nashville, Tennessee, United States, 37232-5536
Vanderbilt Oncology Pharmacy Terminated
Nashville, Tennessee, United States, 37232
Sarah Cannon Research Institute Terminated
Nashville, Tennessee, United States, 37203
Tennessee Oncology, PLLC Terminated
Nashville, Tennessee, United States, 37207
Tennessee Oncology, PLLC Terminated
Nashville, Tennessee, United States, 37211
Tennessee Oncology, PLLC Terminated
Nashville, Tennessee, United States, 37203
Tennessee Oncology, PLLC Terminated
Nashville, Tennessee, United States, 37205
Tennessee Oncology, PLLC Terminated
Smyrna, Tennessee, United States, 37167
United States, Texas
University of Texas Southwestern University Hospital - St. Paul Active, not recruiting
Dallas, Texas, United States, 75232
University of Texas Southwestern Medical Center at Dallas Active, not recruiting
Dallas, Texas, United States, 75390-8852
University of Texas Southwestern University Hospital - Zale Lipshy Active, not recruiting
Dallas, Texas, United States, 75235
University of Texas MD Anderson Cancer Center Terminated
Houston, Texas, United States, 77030
United States, Washington
Seattle Cancer Care Alliance Terminated
Seattle, Washington, United States, 98109
University of Washington Medical Center Terminated
Seattle, Washington, United States, 98195
United States, Wisconsin
University of Wisconsin Hospital and Clinics Terminated
Madison, Wisconsin, United States, 53792-5666
Australia, New South Wales
Macarthur Cancer Therapy Centre Terminated
Campbelltown, New South Wales, Australia, 2560
Chris O'Brien Lifehouse Active, not recruiting
Camperdown, New South Wales, Australia, 2050
North Shore Eye Centre Active, not recruiting
St Leonards, New South Wales, Australia, 2065
Department of Medical Oncology Active, not recruiting
St. Leonards, New South Wales, Australia, 2065
Australia, Queensland
The Prince Charles Hospital Active, not recruiting
Chermside, Queensland, Australia, 4032
Townsville Hospital Completed
Townsville, Queensland, Australia, 4814
Australia, South Australia
Royal Adelaide Hospital, Department of Medical Oncology Terminated
Adelaide, South Australia, Australia, 5000
Australia, Victoria
Peter MacCallum Cancer Centre, Division of Haematology and Medical Oncology Active, not recruiting
East Melbourne, Victoria, Australia, 3002
Southern Eye Centre Active, not recruiting
Frankston, Victoria, Australia, 3199
Peninsula Oncology Centre Active, not recruiting
Frankston, Victoria, Australia, 3199
Austria
KH der Kreuzschwestern Wels-Grieskirchen Terminated
Wels, Austria, 4600
Belgium
Universitair Ziekenhuis Brussel / Medische Oncologie Terminated
Brussel, Belgium, 1090
Cliniques Universitaires St Luc Terminated
Brussels, Belgium, 1200
Institut Jules Bordet, Centre des Tumeurs de l'ULB Terminated
Bruxelles, Belgium, 1000
Centre Hospitalier Notre Dame et Reine Fabiola, Service d'Oncologie Completed
Charleroi, Belgium, 6000
UZ Antwerpen-Pneumologie Completed
Edegem, Belgium, 2650
University Hospital Gent, Thoracic Oncology Terminated
Gent, Belgium, 9000
CHU Liege Terminated
Liege, Belgium, 4000
Heilig Hart Ziekenhuis Roeselare-Menen Active, not recruiting
Roeselare, Belgium, 8800
Brazil
Instituto Nacional do Cancer - INCA Completed
Rio de Janeiro, RJ, Brazil, 20230-130
Instituto Nacional de Câncer - INCA Completed
Rio de Janeiro, RJ, Brazil, 20231 -050
Associacao Hospital de Caridade de Ijui Terminated
Ijui, RS, Brazil, 98700-000
Hospital Sao Lucas da PUCRS Terminated
Porto Alegre, RS, Brazil, 90610-000
Fundacao Pio XII Hospital de Cancer de Barretos Active, not recruiting
Barretos, SP, Brazil, 14784-400
Instituto do Câncer do Estado de São Paulo Octavio Frias de Oliveira - ICESP Terminated
Sao Paulo, SP, Brazil, 01246-000
Canada, Alberta
Cross Cancer Institute Terminated
Edmonton, Alberta, Canada, T6G 1Z2
Canada, Nova Scotia
QEII Health Sciences Centre Terminated
Halifax, Nova Scotia, Canada, B3H 1V7
QEII Health Sciences Centre Terminated
Halifax, Nova Scotia, Canada, B2H 2Y9
Canada, Ontario
RSM Durham Regional Cancer Centre Active, not recruiting
Oshawa, Ontario, Canada, L1G 2B9
Canada, Quebec
Royal Victoria Hospital Active, not recruiting
Montreal, Quebec, Canada, H3A 1A1
Jewish General Hospital Active, not recruiting
Montreal, Quebec, Canada, H3T 1E2
St. Mary's Hospital Centre Active, not recruiting
Montreal, Quebec, Canada, H3T 1M5
Montreal General Hospital Active, not recruiting
Montreal, Quebec, Canada, H3G 1A4
Hopital Laval Active, not recruiting
Ste-Foy, Quebec, Canada, G1V 4G5
Chile
Instituto Clinico Oncologico del Sur Terminated
Temuco, Cautin, Chile, 4810469
Instituto Nacional del Cancer Terminated
Independencia, Santiago, RM, Chile, 8380455
Hospital Clinico Universidad de Chile, Seccion de Oncologia Terminated
Independencia, Santiago, RM, Chile, 8380456
China, Beijing
307 Hospital of PLA Completed
Beijing, Beijing, China, 100071
China, Guangdong
Guangdong General Hospital Active, not recruiting
Guangzhou, Guangdong, China, 510080
China, Hubei
Union Hospital, Tongji Medical College of Huazhong University of Science & Technology/Cancer Center Completed
Wuhan, Hubei, China, 430023
China, Jiangsu
No.81 Hospital of the PLA Active, not recruiting
Nanjing, Jiangsu, China, 210002
Nanjing Bayi Hospital Active, not recruiting
Nanjing, Jiangsu, China, 210002
China, Sichuan
Oncology Department, West China Hospital of Sichuan University Active, not recruiting
Chengdu, Sichuan, China, 610041
China
Cancer Institute and Hospital (CIH), Chinese Academy of Medical Sciences Active, not recruiting
Beijing, China, 100021
Shanghai Pulmonary Hospital/Dept. of Oncology Terminated
Shanghai, China, 200433
Shanghai Chest Hospital/Department of Pulmonary Medicine Active, not recruiting
Shanghai, China, 200030
Finland
Helsingin yliopistollinen keskussairaala, Meilahden kolmiosairaala,Keuhkosairauksien poliklinikka Terminated
Helsinki, Finland, 00290
Satakunnan keskussairaala/Keuhkosairauksien osasto A4 Terminated
Pori, Finland, 28500
Tampereen yliopistollinen sairaala Completed
Tampere, Finland, 33520
France
Hopital Avicenne, Service Oncologie Medicale Terminated
Bobigny Cedex, France, 93009
CHU de la Côte de Nacre Active, not recruiting
Caen Cedex, France, 14033
CHU Grenoble Active, not recruiting
Grenoble Cedex, France, 38043
Centre Oscar Lambret Active, not recruiting
Lille, France, 59020
Centre Leon Berard Terminated
Lyon Cedex 08, France, 69373
APHM - Hopital Nord / Service d'Oncologie Multidisciplinaire et Innovations Thérapeutiques Active, not recruiting
Marseille Cedex 20, France, 13915
Hopital Arnaud de Villeneuve / CHU de Montpellier Terminated
Montpellier, France, 34295
Hopital Tenon, Service de Pneumologie Active, not recruiting
Paris cedex 20, France, 75970
Nouvel Hopital Civil - HSU - Pôle de Pathologie Thoracique - Service de Pneumologie Active, not recruiting
Strasbourg, France, 67091
Germany
Zentralklinik Bad Berka GmbH Active, not recruiting
Bad Berka, Germany, 99437
Charite - Universitaetsmedizin Berlin, Campus Mitte Terminated
Berlin, Germany, 10117
Thoraxklinik am Universitaetsklinikum Heidelberg, Internistische Onkologie der Thoraxtumoren Terminated
Heidelberg, Germany, 69126
Universitaetsklinik Mainz III. Med. Klinik, Abt. Pneumologie Active, not recruiting
Mainz, Germany, 55131
Kliniken Maria Hilf GmbH Terminated
Moenchengladbach, Germany, 41063
Pius-Hospital Oldenburg Active, not recruiting
Oldenburg, Germany, 26121
HSK Dr.- Horst-Schmidt-Kliniken GmbH, Haematologie/Onkologie, Innere Medizin III Active, not recruiting
Wiesbaden, Germany, 65199
Hong Kong
Department of Clinical Oncology, Queen Elizabeth Hospital Active, not recruiting
Kowloon, Hong Kong, 0
Prince of Wales Hospital Active, not recruiting
Shatin, Hong Kong, 0
India
The Gujarat Cancer & Research Institute (M.P Shah Cancer Hospital), Terminated
Ahmedabad,, Gujarat, India, 380 016
Tata Memorial Centre, Tata Memorial Hospital, Terminated
Mumbai, Maharashtra, India, 400012
Ireland
Department of Medical Oncology Active, not recruiting
Dublin, Ireland
Aseptic Compounding Unit Active, not recruiting
Dublin 8, Ireland
Italy
Centro di Riferimento Oncologico, Istituto Nazionale Tumori, IRCCS Active, not recruiting
Aviano (PN), Italy, 33081
Istituto dei tumori Giovanni Paolo II Active, not recruiting
Bari, Italy, 70124
Ospedale Maggiore Bellaria Terminated
Bologna, Italy, 40139
Fondazione per la Ricerca e la Cura dei Tumori Tommaso Campanella, Unità Operativa di Oncologia Completed
Catanzaro, Italy, 88100
UO di Oncologia, Ospedale Civile, Azienda USL 6 di Livorno Active, not recruiting
Livorno, Italy, 57124
Dipartimento di Medicina,Unita' di Farmacologia Clinica Nuovi Farmaci, Active, not recruiting
Milano, Italy, 20141
Fondazione IRCCS Istituto Nazionale Tumori Active, not recruiting
Milano, Italy, 20133
Ospedale Niguarda Ca'Granda, Divisione Oncologia Medica Falck Terminated
Milano, Italy, 20162
A.O.R.N. Dei Colli Plesso Monaldi Active, not recruiting
Napoli, Italy, 80131
Azienda Ospedaliera Universitaria San Luigi Gonzaga Active, not recruiting
Orbassano (TO), Italy, 10043
Oncologia Medica, Azienda Ospedaliera di Parma Active, not recruiting
Parma, Italy, 43100
SC Oncologia Medica, Ospedale Santa Maria della Misericordia, Azienda Ospedaliera di Perugia Terminated
Perugia, Italy, 06132
Azienda Ospedaliera Arcispedale Santa Maria Nuova Completed
Reggio Emilia, Italy, 42100
UO Oncologia Toracica 1, Dipartimento di Malattie Polmonari, Padiglione Maroncelli Active, not recruiting
Roma, Italy, 00152
Istituto Regina Elena, Struttura Complessa Oncologia Medica A Active, not recruiting
Roma, Italy, 00144
Unita Operativa, Oncologia Medica, Istituto di Medicina Interna e Geriatria Terminated
Roma, Italy, 00168
Japan
Aichi cancer center central hospital /Thoracic Oncology Active, not recruiting
Nagoya, Aichi, Japan
National Cancer Center Hospital East Active, not recruiting
Kashiwa, Chiba, Japan
Shikoku Cancer Center / Internal medicine Active, not recruiting
Matsuyama-shi, Ehime, Japan
National Hospital Organization Hokkaido Cancer Center Terminated
Sapporo, Hokkaido, Japan
Hyogo Cancer Center Active, not recruiting
Akashi, Hyogo, Japan
Kanagawa Cardiovascular and Respiratory Center Active, not recruiting
Yokohama, Kanagawa, Japan
Tohoku University Hospital Terminated
Sendai, Miyagi, Japan
Okayama University Hospital Terminated
Okayama-city, Okayama, Japan
Kinki University Hospital Active, not recruiting
Osakasayama-shi, Osaka, Japan
Shizuoka Cancer Center Active, not recruiting
Sunto-gun, Shizuoka, Japan
National Cancer Center Hospital Completed
Chuo-Ku, Tokyo, Japan
National Hospital Organization, Yamaguchi-Ube Medical Center Completed
Ube-shi, Yamaguchi, Japan
National Kyushu Cancer Center/Department of Thoracic Oncology Active, not recruiting
Fukuoka, Japan
Kyushu University Hospital Respiratory Medicine Terminated
Fukuoka, Japan
The Cancer Institute Hospital of JFCR Active, not recruiting
Koto-ku, Tokyo, Japan
Korea, Republic of
Asan Medical Center Active, not recruiting
Seoul, Korea, Republic of, 138-736
Asan Medical Center/Division of Oncology, Department of Internal Medicine Active, not recruiting
Seoul, Korea, Republic of, 138-736
SamsungMedicalCenter,SungkyunkwanUnivSchoolofMedicine,Div. of Hematology-Oncology, Dep. of Medicine Active, not recruiting
Seoul, Korea, Republic of, 135-710
Seoul National University Hospital Recruiting
Seoul, Korea, Republic of, 110-744
Luxembourg
Centre Hospitalier de Luxembourg Active, not recruiting
Luxembourg, Luxembourg, 1210
Mexico
Instituto Nacional de Cancerologia Active, not recruiting
Mexico, D.f., Mexico, 14080
Netherlands
Jeroen Bosch Ziekenhuis Terminated
's Hertogenbosch, Netherlands, 5211 NL
Vrije Universiteit Medical Centre Terminated
Amsterdam, Netherlands, 1081 HV
Academisch Ziekenhuis Maastricht / afdeling longziekten en tuberculose Active, not recruiting
Maastricht, Netherlands, 6229 HX
Jeroen Bosch Ziekenhuis, locatie Groot Ziekengasthuis Terminated
s-Hertogenbosch, Netherlands, 5223 GZ
Norway
Oslo universitetssykehus HF - Radiumhospitalet Active, not recruiting
Oslo, Norway, 0310
Peru
Clinica Anglo Americana/Centro de Investigacion Oncologia CAA Terminated
San Isidro, Lima, Peru, 27
Portugal
Centro Hospitalar de Coimbra Active, not recruiting
Coimbra, Portugal, 3041-801
Centro Hospitalar Lisboa Norte, EPE. Terminated
Lisboa, Portugal, 1769-001
Instituto Português de Oncologia de Lisboa, Prof. Francisco Gentil E.P.E. Terminated
Lisboa, Portugal, 1099-023
Centro Hospitalar de Vila Nova de Gaia/Espinho, E.P.E. Terminated
Vila Nova de Gaia, Portugal, 4434-502
Russian Federation
Russian Oncological Research Center N.N. Blokhin, Chemotherapy Department Active, not recruiting
Moscow, Russian Federation, 115478
First Saint-Petersburg State Medical University n.a. I.P. Pavlov at Ministry of Health of Russian Fe Active, not recruiting
Saint-Petersburg, Russian Federation, 197022
Russian Scientific Center of Radiology and Surgical Technologies Terminated
Saint-Petersburg, Russian Federation, 197758
City Clinical Oncology Dispensary Terminated
Saint-Petersburg, Russian Federation, 197022
City Clinical Oncology Dispensary Terminated
Saint-Petersburg, Russian Federation, 198255
St.-Petersburg State Medical University I.P.Pavlov of Roszdrav Active, not recruiting
Saint-Petersburg, Russian Federation, 197022
Samara Regional Clinical Oncology Dispensary Terminated
Samara, Russian Federation, 443031
Singapore
National Cancer Centre Active, not recruiting
Singapore, Singapore, 169610
Parkway Cancer Centre Terminated
Singapore, Singapore, 228510
OncoCare Cancer Centre Active, not recruiting
Singapore, Singapore, 258499
National University Hospital Active, not recruiting
Singapore, Singapore, 119074
South Africa
Rondebosch Oncology Centre, Rondebosch Medical Centre Terminated
Cape Town, South Africa, 7700
University of Witwatersrand Oncology Active, not recruiting
Parktown, South Africa, 2193
Spain
Hospital General Universitario de Elche Completed
Elche, Alicante, Spain, 03203
Hospital Clinic I Provincial de Barcelona Active, not recruiting
Barcelona, Spain, 08036
Hospital General Universitari Vall D'Hebron Active, not recruiting
Barcelona, Spain, 08035
Hospital Universitario Insular de Gran Canaria Completed
Las Palmas de Gran Canaria, Spain, 35016
Hospital Ramon Y Cajal Active, not recruiting
Madrid, Spain, 28034
Hospital Doce de Octubre Active, not recruiting
Madrid, Spain, 28041
Hospital Universitario Virgen de La Victoria Completed
Malaga, Spain, 29010
Hospital Universitario Virgen Macarena Active, not recruiting
Sevilla, Spain, 41009
Hospital Clinico Universitario Lozano Blesa Active, not recruiting
Zaragoza, Spain, 50009
Switzerland
Kantonsspital Basel Active, not recruiting
Basel, Switzerland, CH-4031
Luzerner Kantonsspital Active, not recruiting
Luzern, Switzerland, 6000
Kantonsspital Active, not recruiting
Winterthur, Switzerland, CH-8401
Taiwan
Chang Gung Medical Foundation, Kaohsiung Branch Terminated
Kaohsiung Hsien, Taiwan, 833
China Medical University Hospital Terminated
Taichung, Taiwan, 404
Taichung Veterans General Hospital, Comprehensive Cancer Center Terminated
Taichung, Taiwan, 40705
Chang Gung Medical Foundation, LinKou Branch Active, not recruiting
Taoyuan, Taiwan, 333
Ukraine
Department of Oncology and Medical Radiology of Dnipropetrovsk State Medical Academy Terminated
Dnipropetrovsk, Ukraine, 49102
Department of Oncology and Medical Radiology of SI "Dnipropetrovsk State Medical Academy of Terminated
Dnipropetrovsk, Ukraine, 49102
Kyiv City Clinical Oncologic Center/Department of Chemotherapy Terminated
Kyiv, Ukraine, 03115
Lviv State Oncologic Regional Treatment and Diagnostic Center Active, not recruiting
Lviv, Ukraine, 79031
United Kingdom
Lister Hospital Terminated
Stevenage, Hertfordshire, United Kingdom, SG1 4AB
Mount Vernon Hospital, Mount Vernon Cancer Centre Terminated
Northwood, Middlesex, United Kingdom, HA6 2RN
Aberdeen Royal Infirmary Terminated
Aberdeen, United Kingdom, AB25 2ZN
Addenbrooke's Hospital, Oncology Centre Terminated
Cambridge, United Kingdom, CB2 0QQ
The Beatson West of Scotland Cancer Centre Active, not recruiting
Glasgow, United Kingdom, G12 0YN
Queen Elizabeth II Hospital Terminated
Hertfordshire, United Kingdom, AL7 4HQ
Christie Hospital NHS Trust, Department of Medical Oncology Active, not recruiting
Manchester, United Kingdom, M20 4BX
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided by Pfizer

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01154140     History of Changes
Other Study ID Numbers: A8081014
Study First Received: June 29, 2010
Last Updated: August 1, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
open label
randomized Phase 3
first line treatment
non squamous lung cancer
ALK translocation event positive

Additional relevant MeSH terms:
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Pemetrexed
Cisplatin
Carboplatin
Crizotinib
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Folic Acid Antagonists
Protein Kinase Inhibitors

ClinicalTrials.gov processed this record on August 27, 2014