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 ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01154140
First received: June 29, 2010
Last updated: April 2, 2014
Last verified: April 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01154140

  Hide Study Locations
Locations
United States, California
CCTAP
Anaheim, California, United States, 92807
CCTAP
Baldwin Park, California, United States, 91706
CCTAP
Bellflower, California, United States, 90706
Tower Cancer Research Foundation
Beverly Hills, California, United States, 90211-1850
Tower Hematology Oncology Medical Group
Beverly Hills, California, United States, 90211-1850
CCTAP
Fontana, California, United States, 92335
CCTAP
Harbor City, California, United States, 90710
CCTAP
Irvine, California, United States, 92618
Loma Linda University Cancer Center-Schuman Pavilion
Loma Linda, California, United States, 92354
Loma Linda University Medical Center Pharmacy
Loma Linda, California, United States, 92354
Records Management Only- Loma Linda Cancer Center
Loma Linda, California, United States, 92354
Loma Linda University Medical Center
Loma Linda, California, United States, 92354
CCTAP
Los Angeles, California, United States, 90027
CCTAP
Los Angeles, California, United States, 90034
CCTAP
Panorama City, California, United States, 91402
CCTAP
Riverside, California, United States, 92505
Kaiser Permanente Southern California
San Diego, California, United States, 92108
CTTAP
San Diego, California, United States, 92120
CCTAP
San Marcos, California, United States, 92069
CCTAP
Woodland Hills, California, United States, 91367
United States, District of Columbia
Georgetown University Hospital
Washington, District of Columbia, United States, 20007
Drug Shipment Address and Pharmacist Designees:
Washington, District of Columbia, United States, 20007
United States, Florida
Lynn Cancer Institute Center for Hematology Oncology
Boca Raton, Florida, United States, 33486
Cancer Institute of Florida
Orlando, Florida, United States, 32804
Investigational Drug Services
Orlando, Florida, United States, 32804
Hematology and Oncology Consultants, PA
Orlando, Florida, United States, 32804
Florida Hospital
Orlando, Florida, United States, 32803
United States, Georgia
Georgia Cancer Specialists
Atlanta, Georgia, United States, 30341
Georgia Cancer Specialists
Decatur, Georgia, United States, 30033
Georgia Cancer Specialists
Macon, Georgia, United States, 31217
Georgia Cancer Specialists
Marietta, Georgia, United States, 30060
Georgia Cancer Specialists
Sandy Springs, Georgia, United States, 30342
United States, Illinois
University of Chicago
Chicago, Illinois, United States, 60637
Monroe Medical Associates
Harvey, Illinois, United States, 60426
Ingalls Memorial Hospital
Harvey, Illinois, United States, 60426
Ship Drug To: Al Fisher, Pharm D.
Harvey, Illinois, United States, 60426
Monroe Medical Associates
Tinley Park, Illinois, United States, 60477
United States, Indiana
Wishard Health Services
Indianapolis, Indiana, United States, 46202
Methodist Hospital
Indianapolis, Indiana, United States, 46206
Indiana University Hospital
Indianapolis, Indiana, United States, 46202
Indiana University Melvin and Bren Simon Cancer Center
Indianapolis, Indiana, United States, 46202
Monroe Medical Association
Munster, Indiana, United States, 46321
The Community Hospital
Munster, Indiana, United States, 46321
United States, Louisiana
Ochsner Clinic Foundation
New Orleans, Louisiana, United States, 70121
United States, Maine
Maine Center for Cancer Medicine
Biddeford, Maine, United States, 04005
Maine Center for Cancer Medicine
Brunswick, Maine, United States, 04011
Maine Center for Cancer Medicine
Sanford, Maine, United States, 04073
Maine Center for Cancer Medicine
Scarborough, Maine, United States, 04074
United States, Michigan
Karmanos Cancer Institute
Detroit, Michigan, United States, 48201
Karmanos Cancer Institute at Farmington Hills
Farmington Hills, Michigan, United States, 48334
United States, Missouri
Siteman Cancer Center - West County
Creve Coeur, Missouri, United States, 63141
Barnes-Jewish Hospital
St. Louis, Missouri, United States, 63110-1094
Washington University School of Medicine
St. Louis, Missouri, United States, 63110-1094
Siteman Cancer Center
St. Peters, Missouri, United States, 63376
United States, New Hampshire
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756-0001
United States, New Jersey
Hematology-Oncology Associates of Northern New Jersey
Morristown, New Jersey, United States, 07962
United States, New Mexico
UNM Eye Clinic
Albuquerque, New Mexico, United States, 87106
University of New Mexico Cancer Center
Albuquerque, New Mexico, United States, 87106
Memorial Medical Center
Las Cruces, New Mexico, United States, 88011
United States, New York
NSLIJ Health System/Monter Cancer Center
Lake Success, New York, United States, 11042
North Shore University Hospital
Manhasset, New York, United States, 11030
Long Island Jewish Medical Center
New Hyde Park, New York, United States, 11040
Department of Medicine MSG at SUNY HSC at Syracuse, Inc.
Oneida, New York, United States, 13421
Department of Medicine MSG at SUNY HSC at Syracuse, Inc.
Oswego, New York, United States, 13126
SUNY Upstate Medical University
Syracuse, New York, United States, 13210-2306
Department of Medicine MSG at SUNY HSC at Syracuse, Inc.
Syracuse, New York, United States, 13210
United States, Oregon
OHSU Knight Cancer Institute
Beaverton, Oregon, United States, 97006
OHSU Knight Cancer Institute
Gresham, Oregon, United States, 97030
OHSU Knight Cancer Institute
Portland, Oregon, United States, 97216
OHSU Knight Cancer Institute
Portland, Oregon, United States, 97210
Oregon Health and Science University
Portland, Oregon, United States, 97239
OHSU Knight Cancer Institute
Tualatin, Oregon, United States, 97062
United States, Pennsylvania
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States, 19111
United States, Rhode Island
Vincent Armenio
East Providence, Rhode Island, United States, 02914
Pharma Resource
East Providence, Rhode Island, United States, 02915
United States, Tennessee
Tennessee Oncology, PLLC
Dickson, Tennessee, United States, 37055
Tennessee Oncology, PLLC
Franklin, Tennessee, United States, 37067
Tennessee Oncology, PLLC
Gallatin, Tennessee, United States, 37066
Tennessee Oncology, PLLC
Hermitage, Tennessee, United States, 37076
Tennessee Oncology, PLLC
Lebanon, Tennessee, United States, 37087
Tennessee Oncology, PLLC
Murfreesboro, Tennessee, United States, 37130
Tennessee Oncology, PLLC
Nashville, Tennessee, United States, 37205
Tennessee Oncology, PLLC
Nashville, Tennessee, United States, 37211
Tennessee Oncology, PLLC
Nashville, Tennessee, United States, 37207
Henry-Joyce Cancer Clinic
Nashville, Tennessee, United States, 37232-5536
Sarah Cannon Research Institute
Nashville, Tennessee, United States, 37203
Vanderbilt Oncology Pharmacy
Nashville, Tennessee, United States, 37232
Tennessee Oncology, PLLC
Nashville, Tennessee, United States, 37203
Tennessee Oncology, PLLC
Smyrna, Tennessee, United States, 37167
United States, Texas
University of Texas Southwestern University Hospital - St. Paul
Dallas, Texas, United States, 75232
University of Texas Southwestern Medical Center at Dallas
Dallas, Texas, United States, 75390-8852
University of Texas Southwestern University Hospital - Zale Lipshy
Dallas, Texas, United States, 75235
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
United States, Washington
Seattle Cancer Care Alliance
Seattle, Washington, United States, 98109
University of Washington Medical Center
Seattle, Washington, United States, 98195
United States, Wisconsin
University of Wisconsin Hospital and Clinics
Madison, Wisconsin, United States, 53792-5666
Australia, New South Wales
Macarthur Cancer Therapy Centre
Campbelltown, New South Wales, Australia, 2560
Sydney Cancer Centre
Camperdown, New South Wales, Australia, 2050
North Shore Eye Centre
St Leonards, New South Wales, Australia, 2065
Department of Medical Oncology
St. Leonards, New South Wales, Australia, 2065
Australia, Queensland
The Prince Charles Hospital
Chermside, Queensland, Australia, 4032
Townsville Hospital
Townsville, Queensland, Australia, 4814
Australia, South Australia
Royal Adelaide Hospital, Department of Medical Oncology
Adelaide, South Australia, Australia, 5000
Australia, Victoria
Peter MacCallum Cancer Centre, Division of Haematology and Medical Oncology
East Melbourne, Victoria, Australia, 3002
Southern Eye Centre
Frankston, Victoria, Australia, 3199
Peninsula Oncology Centre
Frankston, Victoria, Australia, 3199
Austria
KH der Kreuzschwestern Wels-Grieskirchen
Wels, Austria, 4600
Belgium
Universitair Ziekenhuis Brussel / Medische Oncologie
Brussel, Belgium, 1090
Cliniques Universitaires St Luc
Brussels, Belgium, 1200
Institut Jules Bordet, Centre des Tumeurs de l'ULB
Bruxelles, Belgium, 1000
Centre Hospitalier Notre Dame et Reine Fabiola, Service d'Oncologie
Charleroi, Belgium, 6000
UZ Antwerpen-Pneumologie
Edegem, Belgium, 2650
University Hospital Gent, Thoracic Oncology
Gent, Belgium, 9000
CHU Liege
Liege, Belgium, 4000
Heilig Hart Ziekenhuis Roeselare-Menen
Roeselare, Belgium, 8800
Brazil
Instituto Nacional do Cancer - INCA
Rio de Janeiro, RJ, Brazil, 20230-130
Instituto Nacional de Câncer - INCA
Rio de Janeiro, RJ, Brazil, 20231 -050
Associacao Hospital de Caridade de Ijui
Ijui, RS, Brazil, 98700-000
Hospital Sao Lucas da PUCRS
Porto Alegre, RS, Brazil, 90610-000
Fundacao Pio XII Hospital de Cancer de Barretos
Barretos, SP, Brazil, 14784-400
Instituto do Câncer do Estado de São Paulo Octavio Frias de Oliveira - ICESP
Sao Paulo, SP, Brazil, 01246-000
Canada, Alberta
Cross Cancer Institute
Edmonton, Alberta, Canada, T6G 1Z2
Canada, Nova Scotia
QEII Health Sciences Centre
Halifax, Nova Scotia, Canada, B2H 2Y9
QEII Health Sciences Centre
Halifax, Nova Scotia, Canada, B3H 1V7
Canada, Ontario
RSM Durham Regional Cancer Centre
Oshawa, Ontario, Canada, L1G 2B9
Canada, Quebec
Jewish General Hospital
Montreal, Quebec, Canada, H3T 1E2
Royal Victoria Hospital
Montreal, Quebec, Canada, H3A 1A1
St. Mary's Hospital Centre
Montreal, Quebec, Canada, H3T 1M5
Montreal General Hospital
Montreal, Quebec, Canada, H3G 1A4
Hopital Laval
Ste-Foy, Quebec, Canada, G1V 4G5
Chile
Instituto Clinico Oncologico del Sur
Temuco, Cautin, Chile, 4810469
Instituto Nacional del Cancer
Independencia, Santiago, RM, Chile, 8380455
Hospital Clinico Universidad de Chile, Seccion de Oncologia
Independencia, Santiago, RM, Chile, 8380456
China, Beijing
307 Hospital of PLA
Beijing, Beijing, China, 100071
China, Guangdong
Guangdong General Hospital
Guangzhou, Guangdong, China, 510080
China, Hubei
Union Hospital, Tongji Medical College of Huazhong University of Science & Technology/Cancer Center
Wuhan, Hubei, China, 430023
China, Jiangsu
Nanjing Bayi Hospital
Nanjing, Jiangsu, China, 210002
No.81 Hospital of the PLA
Nanjing, Jiangsu, China, 210002
China, Sichuan
Oncology Department, West China Hospital of Sichuan University
Chengdu, Sichuan, China, 610041
China
Cancer Institute and Hospital (CIH), Chinese Academy of Medical Sciences
Beijing, China, 100021
Shanghai Chest Hospital/Department of Pulmonary Medicine
Shanghai, China, 200030
Shanghai Pulmonary Hospital/Dept. of Oncology
Shanghai, China, 200433
Finland
Helsingin yliopistollinen keskussairaala, Meilahden kolmiosairaala,Keuhkosairauksien poliklinikka
Helsinki, Finland, 00290
Satakunnan keskussairaala/Keuhkosairauksien osasto A4
Pori, Finland, 28500
Tampereen yliopistollinen sairaala
Tampere, Finland, 33520
France
Hopital Avicenne, Service Oncologie Medicale
Bobigny Cedex, France, 93009
CHU de la Côte de Nacre
Caen Cedex, France, 14033
CHU Grenoble
Grenoble Cedex, France, 38043
Centre Oscar Lambret
Lille, France, 59020
Centre Leon Berard
Lyon Cedex 08, France, 69373
APHM - Hopital Nord / Service d'Oncologie Multidisciplinaire et Innovations Thérapeutiques
Marseille Cedex 20, France, 13915
Hopital Arnaud de Villeneuve / CHU de Montpellier
Montpellier, France, 34295
Hopital Tenon, Service de Pneumologie
Paris cedex 20, France, 75970
Nouvel Hopital Civil - HSU - Pôle de Pathologie Thoracique - Service de Pneumologie
Strasbourg, France, 67091
Germany
Zentralklinik Bad Berka GmbH
Bad Berka, Germany, 99437
Charite - Universitaetsmedizin Berlin, Campus Mitte
Berlin, Germany, 10117
Thoraxklinik am Universitaetsklinikum Heidelberg, Internistische Onkologie der Thoraxtumoren
Heidelberg, Germany, 69126
Universitaetsklinik Mainz III. Med. Klinik, Abt. Pneumologie
Mainz, Germany, 55131
Kliniken Maria Hilf GmbH
Moenchengladbach, Germany, 41063
Pius-Hospital Oldenburg
Oldenburg, Germany, 26121
HSK Dr.- Horst-Schmidt-Kliniken GmbH, Haematologie/Onkologie, Innere Medizin III
Wiesbaden, Germany, 65199
Hong Kong
Department of Clinical Oncology, Queen Elizabeth Hospital
Kowloon, Hong Kong, 0
Prince of Wales Hospital
Shatin, Hong Kong, 0
India
The Gujarat Cancer & Research Institute (M.P Shah Cancer Hospital),
Ahmedabad,, Gujarat, India, 380 016
Tata Memorial Centre, Tata Memorial Hospital,
Mumbai, Maharashtra, India, 400012
Ireland
Department of Medical Oncology
Dublin, Ireland
Aseptic Compounding Unit
Dublin 8, Ireland
Italy
Centro di Riferimento Oncologico, Istituto Nazionale Tumori, IRCCS
Aviano (PN), Italy, 33081
Istituto dei tumori Giovanni Paolo II
Bari, Italy, 70124
Ospedale Maggiore Bellaria
Bologna, Italy, 40139
Fondazione per la Ricerca e la Cura dei Tumori Tommaso Campanella, Unità Operativa di Oncologia
Catanzaro, Italy, 88100
UO di Oncologia, Ospedale Civile, Azienda USL 6 di Livorno
Livorno, Italy, 57124
Ospedale Niguarda Ca'Granda, Divisione Oncologia Medica Falck
Milano, Italy, 20162
Fondazione IRCCS Istituto Nazionale Tumori
Milano, Italy, 20133
Dipartimento di Medicina,Unita' di Farmacologia Clinica Nuovi Farmaci,
Milano, Italy, 20141
A.O.R.N. Dei Colli Plesso Monaldi
Napoli, Italy, 80131
Azienda Ospedaliera Universitaria San Luigi Gonzaga
Orbassano (TO), Italy, 10043
Oncologia Medica, Azienda Ospedaliera di Parma
Parma, Italy, 43100
SC Oncologia Medica, Ospedale Santa Maria della Misericordia, Azienda Ospedaliera di Perugia
Perugia, Italy, 06132
Azienda Ospedaliera Arcispedale Santa Maria Nuova
Reggio Emilia, Italy, 42100
UO Oncologia Toracica 1, Dipartimento di Malattie Polmonari, Padiglione Maroncelli
Roma, Italy, 00152
Unita Operativa, Oncologia Medica, Istituto di Medicina Interna e Geriatria
Roma, Italy, 00168
Istituto Regina Elena, Struttura Complessa Oncologia Medica A
Roma, Italy, 00144
Japan
Aichi cancer center central hospital /Thoracic Oncology
Nagoya, Aichi, Japan
National Cancer Center Hospital East
Kashiwa, Chiba, Japan
Shikoku Cancer Center / Internal medicine
Matsuyama-shi, 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
National Hospital Organization, Yamaguchi-Ube Medical Center
Ube-shi, Yamaguchi, Japan
National Kyushu Cancer Center/Department of Thoracic Oncology
Fukuoka, Japan
Kyushu University Hospital Respiratory Medicine
Fukuoka, Japan
The Cancer Institute Hospital of JFCR
Koto-ku, Tokyo, Japan
Korea, Republic of
Seoul National University Hospital
Seoul, Korea, Republic of, 110-744
Asan Medical Center
Seoul, Korea, Republic of, 138-736
Asan Medical Center/Division of Oncology, Department of Internal Medicine
Seoul, Korea, Republic of, 138-736
SamsungMedicalCenter,SungkyunkwanUnivSchoolofMedicine,Div. of Hematology-Oncology, Dep. of Medicine
Seoul, Korea, Republic of, 135-710
Luxembourg
Centre Hospitalier de Luxembourg
Luxembourg, Luxembourg, 1210
Mexico
Instituto Nacional de Cancerologia
Mexico, D.f., Mexico, 14080
Netherlands
Jeroen Bosch Ziekenhuis
's Hertogenbosch, Netherlands, 5211 NL
Vrije Universiteit Medical Centre
Amsterdam, Netherlands, 1081 HV
Academisch Ziekenhuis Maastricht / afdeling longziekten en tuberculose
Maastricht, Netherlands, 6229 HX
Jeroen Bosch Ziekenhuis, locatie Groot Ziekengasthuis
s-Hertogenbosch, Netherlands, 5223 GZ
Norway
Oslo universitetssykehus HF - Radiumhospitalet
Oslo, Norway, 0310
Peru
Clinica Anglo Americana/Centro de Investigacion Oncologia CAA
San Isidro, Lima, Peru, 27
Portugal
Centro Hospitalar de Coimbra
Coimbra, Portugal, 3041-801
Centro Hospitalar Lisboa Norte, EPE.
Lisboa, Portugal, 1769-001
Instituto Português de Oncologia de Lisboa, Prof. Francisco Gentil E.P.E.
Lisboa, Portugal, 1099-023
Centro Hospitalar de Vila Nova de Gaia/Espinho, E.P.E.
Vila Nova de Gaia, Portugal, 4434-502
Russian Federation
Russian Oncological Research Center N.N. Blokhin, Chemotherapy Department
Moscow, Russian Federation, 115478
City Clinical Oncology Dispensary
Saint-Petersburg, Russian Federation, 197022
Research Institute of Pulmonology
Saint-Petersburg, Russian Federation, 197089
City Clinical Oncology Dispensary
Saint-Petersburg, Russian Federation, 198255
Russian Scientific Center of Radiology and Surgical Technologies
Saint-Petersburg, Russian Federation, 197758
St.-Petersburg State Medical University I.P.Pavlov of Roszdrav
Saint-Petersburg, Russian Federation, 197022
Samara Regional Clinical Oncology Dispensary
Samara, Russian Federation, 443031
Singapore
National Cancer Centre
Singapore, Singapore, 169610
Parkway Cancer Centre
Singapore, Singapore, 228510
OncoCare Cancer Centre
Singapore, Singapore, 258499
National University Hospital
Singapore, Singapore, 119074
South Africa
Rondebosch Oncology Centre, Rondebosch Medical Centre
Cape Town, South Africa, 7700
University of Witwatersrand Oncology
Parktown, South Africa, 2193
Spain
Hospital General Universitario de Elche
Elche, Alicante, Spain, 03203
Hospital Clinic I Provincial de Barcelona
Barcelona, Spain, 08036
Hospital General Universitari Vall D'Hebron
Barcelona, Spain, 08035
Hospital Universitario Insular de Gran Canaria
Las Palmas de Gran Canaria, Spain, 35016
Hospital Ramon Y Cajal
Madrid, Spain, 28034
Hospital Doce de Octubre
Madrid, Spain, 28041
Hospital Universitario Virgen de La Victoria
Malaga, Spain, 29010
Hospital Universitario Virgen Macarena
Sevilla, Spain, 41009
Hospital Clinico Universitario Lozano Blesa
Zaragoza, Spain, 50009
Switzerland
Kantonsspital Basel
Basel, Switzerland, CH-4031
Luzerner Kantonsspital
Luzern, Switzerland, 6000
Kantonsspital
Winterthur, Switzerland, CH-8401
Taiwan
Chang Gung Medical Foundation, Kaohsiung Branch
Kaohsiung Hsien, Taiwan, 833
China Medical University Hospital
Taichung, Taiwan, 404
Taichung Veterans General Hospital, Comprehensive Cancer Center
Taichung, Taiwan, 40705
Chang Gung Medical Foundation, LinKou Branch
Taoyuan, Taiwan, 333
Ukraine
Department of Oncology and Medical Radiology of Dnipropetrovsk State Medical Academy
Dnipropetrovsk, Ukraine, 49102
Department of Oncology and Medical Radiology of SI "Dnipropetrovsk State Medical Academy of
Dnipropetrovsk, Ukraine, 49102
Kyiv City Clinical Oncologic Center/Department of Chemotherapy
Kyiv, Ukraine, 03115
Lviv State Oncologic Regional Treatment and Diagnostic Center
Lviv, Ukraine, 79031
United Kingdom
Lister Hospital
Stevenage, Hertfordshire, United Kingdom, SG1 4AB
Mount Vernon Hospital, Mount Vernon Cancer Centre
Northwood, Middlesex, United Kingdom, HA6 2RN
Aberdeen Royal Infirmary
Aberdeen, United Kingdom, AB25 2ZN
Addenbrooke's Hospital, Oncology Centre
Cambridge, United Kingdom, CB2 0QQ
The Beatson West of Scotland Cancer Centre
Glasgow, United Kingdom, G12 0YN
Queen Elizabeth II Hospital
Hertfordshire, United Kingdom, AL7 4HQ
Christie Hospital NHS Trust, Department of Medical Oncology
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: April 2, 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
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Folic Acid Antagonists
Antimetabolites, Antineoplastic
Antimetabolites

ClinicalTrials.gov processed this record on April 23, 2014