Trial record 1 of 1 for:    A7471009
Previous Study | Return to List | Next Study

ARCHER 1009 : A Study Of Dacomitinib (PF-00299804) Vs. Erlotinib In The Treatment Of Advanced Non-Small Cell Lung Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01360554
First received: April 12, 2011
Last updated: April 30, 2015
Last verified: April 2015
  Purpose

This is a multinational, multicenter, randomized,double-blinded, Phase 3 study comparing the efficacy and safety of treatment with PF-00299804 to treatment with erlotinib in patients with advanced non-small cell lung cancer, previously treated with at least one prior regimen. Analyses of primary objective (Progression Free Survival) will be done in two co-primary populations as defined in the protocol.


Condition Intervention Phase
Non-Small Cell Lung Cancer (NSCLC)
Drug: Dacomitinib (PF-00299804)
Drug: Active Comparator (erlotinib)
Drug: Placebo erlotinib
Drug: Placebo PF00299804
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Archer 1009:a Randomized, Double Blind Phase 3 Efficacy And Safety Study Of Pf-00299804 (Dacomitinib) Versus Erlotinib For The Treatment Of Advanced Non-small Cell Lung Cancer Following Progression After, Or Intolerance To, At Least One Prior Chemotherapy

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Progression Free Survival per Independent Radiologic review in two co-primary populations. [ Time Frame: 10 months after anticipated LSLV ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall Survival [ Time Frame: 12 months after anticipated LSLV ] [ Designated as safety issue: No ]
  • Progression-Free Survival per Investigator [ Time Frame: 4 months after anticipated LSLV ] [ Designated as safety issue: No ]
  • Best Overall Response [ Time Frame: 6 months after ] [ Designated as safety issue: No ]
  • Duration of Response [ Time Frame: 6 months from LSLV until progression ] [ Designated as safety issue: No ]
  • Overall Safety by CTCAE grading at each specified visit, LVEF every 3-6 months [ Time Frame: until resolution of any unresolved treatment-related adverse event for 6 months from LSLV ] [ Designated as safety issue: Yes ]
  • Patient Reported Outcomes of health-related quality of life, diseases symptoms, health status [ Time Frame: 6 months from LSLV ] [ Designated as safety issue: No ]
  • KRAS mutation status in tissue sample and HER family genotypes from serum samples at baseline [ Time Frame: baseline, and 12 months from LSLV ] [ Designated as safety issue: No ]
  • PK trough concentrations [ Time Frame: 12 months from LSLV ] [ Designated as safety issue: No ]

Estimated Enrollment: 880
Study Start Date: June 2011
Estimated Study Completion Date: August 2015
Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
Blinded active PF-00299804 + blinded placebo comparator (erlotinib)
Drug: Dacomitinib (PF-00299804)
Dacomitinib (PF-00299804) is provided as 45 mg tablets, continuous oral daily dosing
Other Name: Dacomitinib (PF-00299804)
Drug: Placebo erlotinib
placebo erlotinib, provided as 150 mg tablet, continuous oral daily dosing.
Active Comparator: B
Blinded active comparator (erlotinib) + blinded placebo PF-00299804
Drug: Active Comparator (erlotinib)
Active comparator (erlotinib) provided as 150 mg tablet, continuous oral daily dosing
Drug: Placebo PF00299804
placebo PF-00299804, provide as 45 mg tablet, continuous oral daily dosing

  Eligibility

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

Inclusion Criteria:

  • Evidence of pathologically confirmed, advanced NSCLC (with known histology).
  • Prior treatment with at least one and no more than two systemic therapy regimens (at least one must be standard chemotherapy for advanced NSCLC).
  • Adequate tissue sample must be submitted prior to randomization for tumor biomarker analyses.
  • Adequate renal, hematologic, liver function.
  • ECOG PS of 0-2.
  • Radiologically measurable disease.

Exclusion Criteria:

  • Small cell histology.
  • Symptomatic brain mets or known leptomeningeal mets.
  • Prior therapy with agent known or proposed to be active by action on EGFR tyrosine kinase or other HER family proteins.
  • Uncontrolled medical disorders.
  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: NCT01360554

  Hide Study Locations
Locations
United States, Alabama
University of Alabama at Birmingham Comprehensive Cancer Center
Birmingham, Alabama, United States, 35294-3300
University of South Alabama Mitchell Cancer Institute
Mobile, Alabama, United States, 36604
Northwest Alabama Cancer Center
Muscle Shoals, Alabama, United States, 35661
United States, Arizona
Ironwood Physicians P.C. dba Ironwood Cancer and Research Centers
Gilbert, Arizona, United States, 85297
Desert Oncology Associates dba Ironwood Cancer and Research Centers
Mesa, Arizona, United States, 85202
Ironwood Physicians P.C. dba Ironwood Cancer and Research Centers
Mesa, Arizona, United States, 85206
United States, Arkansas
Highlands Oncology Group, PA
Fayetteville, Arkansas, United States, 72703
Highlands Oncology Group
Fayetteville, Arkansas, United States, 72703-4005
Highlands Oncology Group, PA
Rogers, Arkansas, United States, 72758
United States, California
Central Hematology-Oncology Medical Group, Inc.
Alhambra, California, United States, 91801
UCLA Hematology Oncology-Alhambra
Alhambra, California, United States, 91801
City of Hope
Duarte, California, United States, 91010
St. Jude Heritage Healthcare
Fullerton, California, United States, 92835
Westwood Bowyer Clinic, Peter Morton Medical Building
Los Angeles, California, United States, 90095
Drug Management Only
Los Angeles, California, United States, 90095-1772
Drug Shipment Address: Ronald Reagan UCLA Medical Center, Drug Information Center
Los Angeles, California, United States, 90095
Regulatory Management
Los Angeles, California, United States, 90095
Regulatory Management:
Los Angeles, California, United States, 90095
Ronald Reagan UCLA Medical Center
Los Angeles, California, United States, 90095
Administrative Address: UCLA Hematology Oncology-Clinical Research Unit (CRU)
Los Angeles, California, United States, 90095
UCLA West Medical Pharmacy
Los Angeles, California, United States, 90095-1772
TORI Central Administration
Los Angeles, California, United States, 90095
Central Hematology Oncology Medical Group, Inc.
Pasadena, California, United States, 91107
UCLA/Pasadena Healthcare Hematology-Oncology
Pasadena, California, United States, 91105
Cancer Care Associates Medical Group Inc.
Redondo Beach, California, United States, 90277
Central Coast Medical Oncology Corporation
Santa Maria, California, United States, 93454
UCLA Hematology Oncology-Parkside
Santa Monica, California, United States, 90404
UCLA Hematology Oncology-Santa Monica
Santa Monica, California, United States, 90404
UCLA Santa Monica Medical Center & Orthopedic Hospital
Santa Monica, California, United States, 90404
University of California, Los Angeles
Santa Monica, California, United States, 90404
City of Hope South Pasadena Cancer Center
South Pasadena, California, United States, 91030
UCLA/Santa Clarita Valley Cancer Center
Valencia, California, United States, 91355
UCLA Cancer Center
Westlake Village, California, United States, 91361
United States, Connecticut
Norwalk Hospital
Norwalk, Connecticut, United States, 06856
United States, Florida
Florida Hospital
Orlando, Florida, United States, 32803
Florida Hospital Medical Group (FHMG) - Cancer Institute of Florida - Orlando
Orlando, Florida, United States, 32804-4648
Hematology and Oncology Consultants, P.A.
Orlando, Florida, United States, 32804
Cancer Institute of Florida
Orlando, Florida, United States, 32804
Hematology Oncology Associates of the Treasure Coast
Port St. Lucie, Florida, United States, 34952
United States, Georgia
Winship Cancer Institute, Emory University
Atlanta, Georgia, United States, 30322
Georgia Core
Atlanta, Georgia, United States, 30303
Winship Cancer Institute of Emory University
Atlanta, Georgia, United States, 30308
Northwest Georgia Oncology Centers, P.C.
Austell, Georgia, United States, 30106
University of Colorado - Anschutz Medical Campus - University of Colorado Cancer Center
Austell, Georgia, United States, 30106-8116
Northwest Georgia Oncology Centers, P.C.
Carrollton, Georgia, United States, 30117
Northwest Georgia Oncology Centers, PC
Cartersville, Georgia, United States, 30121
John B. Amos Cancer Center
Columbus, Georgia, United States, 31904
Dekalb Medical
Decatur, Georgia, United States, 30033
Georgia Cancer Specialists
Decatur, Georgia, United States, 30033
The Cancer Center at DeKalb Medical
Decatur, Georgia, United States, 30033
The Cancer Center, Dekalb Medical
Decatur, Georgia, United States, 30033
Atlanta Cancer Care
Decatur, Georgia, United States, 30033
Northwest Georgia Oncology Centers, P.C.
Douglasville, Georgia, United States, 30134
Suburban Hematology-Oncology Associates, P.C.
Duluth, Georgia, United States, 30096
The Longstreet Clinic Cancer Center
Gainesville, Georgia, United States, 30501
Oncology Specialists of North Georgia, LLC
Gainesville, Georgia, United States, 30501
Northeast Georgia Medical Center
Gainesville, Georgia, United States, 30501
Suburban Hematology-Oncology Associates, P.C.
Lawrenceville, Georgia, United States, 30046
Suburban Hematology-Oncology Associates, Pc
Lawrenceville, Georgia, United States, 30046
Northwest Georgia Oncology Centers, P.C.
Marietta, Georgia, United States, 30060
Northwest Georgia Oncology Centers, P.C. - William S. Gibbons Cancer Research Institute
Marietta, Georgia, United States, 30060
Northwest Georgia Oncology Centers, PC
Marietta, Georgia, United States, 30060
Suburban Hematology-Oncology Associates
Snellville, Georgia, United States, 30078
Suburban Hematology-Oncology Associates, P.C.
Snellville, Georgia, United States, 30078
United States, Illinois
Illinois Cancer Specialists
Arlington Heights, Illinois, United States, 60005
Ingalls Memorial Hospital
Harvey, Illinois, United States, 60426
Ingalls Memorial Hospital - In-Patient Pharmacy
Harvey, Illinois, United States, 60426
Monroe Medical Associates
Harvey, Illinois, United States, 60426
Illinois Cancer Specialists
Niles, Illinois, United States, 60714
Monroe Medical Associates
Tinley Park, Illinois, United States, 60477
United States, Indiana
Deaconess Clinic Downtown
Evansville, Indiana, United States, 47713
Monroe Medical Associates
Munster, Indiana, United States, 46321
United States, Iowa
Cedar Valley Medical Specialists, P.C.
Waterloo, Iowa, United States, 50701
United States, Kentucky
Kentucky Cancer Clinic
Hazard, Kentucky, United States, 41701-9466
Baptist Hospital East
Louisville, Kentucky, United States, 40207
University of Louisville
Louisville, Kentucky, United States, 40202
University Medical Center, Inc.
Louisville, Kentucky, United States, 40202
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, Mississippi
North Mississippi Hematology and Oncology Associates, Ltd.
Corinth, Mississippi, United States, 38834
North Mississippi Hematology and Oncology Associates, Ltd.
Starkville, Mississippi, United States, 39759
North Mississippi Hematology and Oncology Associates, Ltd.
Tupelo, Mississippi, United States, 38801
United States, Missouri
Siteman Cancer Center-West County
Creve Coeur, Missouri, United States, 63141
Washington University School of Medicine
Saint Louis, Missouri, United States, 63110
Washington University School of Medicine
St. Louis, Missouri, United States, 63110
Barnes Jewish Hospital
St. Louis, Missouri, United States, 63110-1094
Washington University School of Medicine
St. Louis, Missouri, United States, 63130
Washington University School of Medicine in St. Louis
St. Louis, Missouri, United States, 63110-1093
Washington University School of Medicine in St. Louis
St. Louis, Missouri, United States, 63110
Siteman Cancer Center-St. Peters
St. Peters, Missouri, United States, 63376-1645
United States, New Hampshire
Dartmouth-Hitchcock Medical Center /Mary Hitchcock Memorial Hospital
Lebanon, New Hampshire, United States, 03756
United States, New Jersey
Oncology and Hematology Specialists, P.A.
Denville, New Jersey, United States, 07834
United States, New York
Stony Brook University
Stony Brook, New York, United States, 11794-8151
Stony Brook University-Cancer Center
Stony Brook, New York, United States, 11794-9447
Stony Brook University Medical Center - Division of Hematology/Oncology
Stony Brook, New York, United States, 11794
Stony Brook University Medical Center Cancer Center
Stony Brook, New York, United States, 11794-9447
Stony Brook University Division of Hematology/Oncology
Stony Brook, New York, United States, 11794-8151
United States, North Carolina
Carolina Oncology Specialists, PA
Hickory, North Carolina, United States, 28602
Carolina Oncology Specialists, PA
Lenoir, North Carolina, United States, 28645
United States, Oklahoma
Mercy clinic oklahoma communities, Inc. - Mercy clinic oncology/Hematology - Norman
Norman, Oklahoma, United States, 73071
Mercy Hospital Oklahoma City - Oncology Infusion
Oklahoma City, Oklahoma, United States, 73120
Mercy Physicians of Oklahoma
Oklahoma City, Oklahoma, United States, 73120
Mercy Physicians of Oklahoma
Oklahoma City, Oklahoma, United States, 73120-8347
Mercy Physicians of Oklahoma-Communities, Inc. - Mercy Clinic Oncology/Hematology - McAuley
Oklahoma City, Oklahoma, United States, 73120-8347
United States, Oregon
Good Samaritan Hospital, Corvallis-Samaritan Hematology and Oncology Consultants
Corvallis, Oregon, United States, 97330
Good Samaritan Hospital Samaritan Ambulatory Infusion Services
Corvallis, Oregon, United States, 97330
Samaritan Hematology and Oncology Consultants
Corvallis, Oregon, United States, 97330
Samaritan Pharmacy Services
Corvallis, Oregon, United States, 97330
Samaritan North Lincoln Hospital
Lincoln City, Oregon, United States, 97367
Samaritan Pacific Communities Hospital
Newport, Oregon, United States, 97365
United States, Pennsylvania
Guthrie Clinic Limited
Sayre, Pennsylvania, United States, 18840
Guthrie Clinic, Limited
Sayre, Pennsylvania, United States, 18840
Robert Packer Hospital
Sayre, Pennsylvania, United States, 18840
United States, Texas
Texas Oncology-Longview Cancer Center
Longview, Texas, United States, 75601
Texas Oncology-Tyler
Tyler, Texas, United States, 75702
Texas Oncology - Waco
Waco, Texas, United States, 76712
United States, Washington
Columbia Basin Hematology and Oncology
Kennewick, Washington, United States, 99336
University of Washington - Seattle Cancer Care Alliance (SCCA)
Seattle, Washington, United States, 98109
University of Washington - School of Medicine,
Seattle, Washington, United States, 98109
Seattle Cancer Care Alliance
Seattle, Washington, United States, 98109
Austria
Sozialmedizinisches Zentrum Baumgartner Hoehe - Otto-Wagner-Spital
Wien, Austria, 1140
Belgium
Institut Jules Bordet
Brussels, Belgium, 1000
Laboratoire de la Porte de Hall
Brussels, Belgium, 1000
Grand Hopital de Charleroi / Service d'Hematologie et Oncologie
Charleroi, Belgium, 6000
Centre Hospitalier Universitaire Ambroise Pare (CHU Ambroise Pare) Hématologie
Mons, Belgium, 7000
Heilig Hart Ziekenhuis Roeselare-Menen
Roeselare, Belgium, 8800
China, Guangxi
Tumour Hospital of Guangxi Zhuang Autonomous Region
Nanning, Guangxi, China, 530021
China, Hubei
Union Hospital, Tongji Medical College of Huazhong University of Science & Technology/Cancer Center
Wuhan, Hubei, China, 430023
China, Jilin
Jilin Provincial Cancer Hospital, Department of Oncology
Changchun, Jilin, China, 130012
China, Sichuan
West China Hospital of Sichuan University/Oncology Department
Chengdu, Sichuan, China, 610041
China
Department of Oncology, Jilin Provincial Cancer Hospital
Changchun, China, 130012
Shanghai Pulmonary Hospital
Shanghai, China, 200433
Denmark
Aalborg Sygehus Syd
Aalborg, Denmark, 9100
Finland
Helsingin yliopistollinen sairaala, Meilahden kolmiosairaala, keuhkosairauksien poliklinikka
Helsinki, Finland, 00290
Satakunnan keskussairaala/Keuhkosairauksien osasto A4
Pori, Finland, 28500
Satakunnan Keskussairaalan laboratorio
Pori, Finland, 28500
France
Centre Georges Francois Leclerc
Dijon, France, 21079
Hopital Albert Michallon
Grenoble Cedex 09, France, 38043
Hôpital Paris Saint Joseph
Paris, France, 75014
CHU de Poitiers
Poitiers Cedex, France, 86021
Institut de Cancérologie de l'Ouest - René Gauducheau
Saint-Herblain, France, 44805
Germany
Universitaetsklinikum Aachen
Aachen, Germany, 52074
Asklepios Fachkliniken Muenchen-Gauting
Gauting, Germany, 82131
Lungenfachklinik Immenhausen
Immenhausen, Germany, 34376
Universitaetsmedizin der Johannes Gutenberg-Universitaet
Mainz, Germany, 55131
Krankenhaus Bethanien, Medizinische Klinik III
Moers, Germany, 47441
Greece
Sotiria General Hospital of Athens
Athens, Greece, 11527
University Hospital of Heraklion
Heraklion, Greece, 71110
University Hospital of Larissa
Larissa, Greece, 41110
Hungary
Semmelweis Egyetem Pulmonologiai Klinika
Budapest, Hungary, 1125
Debreceni Egyetem Orvos- es Egeszsegtudomanyi Centrum
Debrecen, Hungary, 4032
Veszprem Megyei Onkormanyzat Tudogyogyintezete
Farkasgyepu, Hungary, 8582
Pandy Kalman Megyei Korhaz, Aktiv Tudogyogyaszat
Gyula, Hungary, 5703
Josa Andras Oktatokorhaz Egeszsegugyi Szolgaltato Nonprofit Kft.
Nyiregyhaza, Hungary, 4412
Zala Megyei Korhaz, Pulmonologiai Osztaly
Zalaegerszeg-Pozva, Hungary, 8900
India
Vedanta Institute of Medical Sciences
Ahmedabad, Gujarat, India, 380 009
Manipal Hospital
Bangalore, Karnataka, India, 560017
Tata Memorial Centre
Mumbai, Maharashtra, India, 400012
Ruby Hall Clinic
Pune, Maharastra, India, 411001
Ireland
Beaumont Hospital
Dublin, Leinster, Ireland, Dublin 9
3rd Floor Oncology
Dublin, Ireland, 4
St. James Hospital
Dublin, Ireland, 8
Oncology Department
Waterford, Ireland
Japan
Aichi cancer center central hospital /Thoracic Surgery
Nagoya, Aichi, Japan, 464-8681
Aichi Cancer Center Central Hospital /Respiratory Surgery
Nagoya, Aichi, Japan, 464-8681
Aichi cancer center central hospital /Thoracic Oncology
Nagoya, Aichi, Japan, 464-8681
Aichi Cancer Center Central Hospital, Diagnostic and Interventional Radiology
Nagoya, Aichi, Japan, 464-8681
Aichi Cancer Center Central Hospital, Pathology and Molecular Diagnostics
Nagoya, Aichi, Japan, 464-8681
Aichi Cancer Center Hospital
Nagoya, Aichi, Japan, 464-8681
EPMint Co.,Ltd
Nagoya, Aichi, Japan, 460-0003
Aichi cancer center central hospital
Nagoya, Aichi, Japan, 464-8681
National Cancer Center East Hospital
Kashiwa, Chiba, Japan, 277-8577
National Cancer Center Hospital East
Kashiwa, Chiba, Japan, 277-8577
National Hospital Organization Shikoku Cancer Center
Matsuyama, Ehime, Japan, 791-0280
Shoichiro
Matsuyama, Ehime, Japan, 791-0280
National Hospital Organization Shikoku Cancer Center
Matsuyama-city, Ehime, Japan, 791-0280
Kyushu University Hospital
Fukuoka-shi, Fukuoka-ken, Japan, 812-8582
National Hospital Organization Asahikawa Medical Center
Asahikawa, Hokkaido, Japan, 070-8644
National Hospital Organization Asahikawa National Hospita
Asahikawa, Hokkaido, Japan, 070-8644
Hyogo Cancer Center
Akashi, Hyogo, Japan, 673-8558
Hyogo Cancer Center
Akashi-shi, Hyogo, Japan, 673-8558
Kanazawa University Hospital
Kanazawa city, Ishikawa, Japan, 920-8641
Kanazawa University Hospital, Department of Gastroenterology
Kanazawa city, Ishikawa, Japan, 9208641
Kanazawa University Hospital
Kanazawa-shi, Ishikawa, Japan, 920-8641
Kanagawa Cardiovascular and Respiratory Center
Yokohama, Kanagawa, Japan, 236-0051
Tohoku University Hospital
Sendai, Miyagi, Japan, 980-8574
Tohoku University Hospital
Sendai-city, Miyagi, Japan, 980-8574
Okayama University Hospital
Okayama-shi, Okayama-ken, Japan, 700-8558
Kurashiki Central Hospital
Kurashiki, Okayama, Japan, 710-8602
Kurashiki Central Hospital
Kurashiki-shi, Okayama, Japan, 710-8602
Okayama University Hospital
Okayama-city, Okayama, Japan, 700-8558
Okayama University Hospital
Okayama-shi, Okayama, Japan, 700-8558
National Hospital Organization Kinki-chuo Chest Medical Center
Sakai, Osaka-fu, Japan, 591-8555
National Hospital Organization Kinki-chuo Chest Medical Center
Sakai-shi, Osaka-fu, Japan, 591-8555
Osaka City General Hospital Department of Pathology
Miyakojima-ku, Osaka, Japan, 534-0021
Osaka City General Hospital Department of Respiratory Medicine
Osaka-City, Osaka, Japan, 534-0021
Osaka City General Hospital Department of Clinical Oncology
Osaka-city, Osaka, Japan, 534-0021
Osaka City General Hospital
Osaka-city, Osaka, Japan, 534-0021
Kinki University Hospital
Osakasayama-shi, Osaka, Japan, 589-8511
Shizuoka Cancer Center
Sunto-gun, Shizuoka, Japan, 411-8777
National Cancer Center Hospital
Chuo-Ku, Tokyo, Japan, 104-0045
National Cancer Center
Chuo-ku, Tokyo, Japan, 104-0045
National Hospital Organization, Yamaguchi-Ube Medical Center
Ube-shi, Yamaguchi, Japan, 755-0241
NHO Yamaguchi-Ube Medical Center
Ube-shi, Yamaguchi, Japan, 7550241
Kyushu University Hospital Outpatient Chemotherapy
Fukuoka, Japan, 812-8582
Kyushu University Hospital Respiratory Medicine
Fukuoka, Japan, 812-8582
National Hospital Organization
Fukuoka, Japan, 810-8563
National Hospital Organization Kyushu Cancer Center/Department of Thoracic Oncology
Fukuoka, Japan, 811-1395
National Hospital Organization Kyushu Medical Center
Fukuoka, Japan, 810-8563
National Hp. Org. Kyushu Medical Center
Fukuoka, Japan, 810-8563
The Cancer Institute Hospital of JFCR
Koto-ku, Tokyo, Japan, 135-8550
Okayama University Hospital
Okayama, Japan, 700-8558
Korea, Republic of
Samsung Medical Center
Seoul, Korea (South), Korea, Republic of, 135-710
Seoul National University Hospital
Seoul, Korea, Republic of, 110-744
Samsung Medical Center, Clinical Trial Pharmacy
Seoul, Korea, Republic of, 135-710
Asan Medical Center, Department of Oncology
Seoul, Korea, Republic of, 138-736
Mexico
Oaxaca Site Management Organization
Oaxaca, Oaxaca C.P., Mexico, 68000
Oaxaca Site Management Organization
Oaxaca, Mexico, 68000
Poland
Zoz All-Medi
Otwock, Mazowieckie, Poland, 05-400
Nukleomed
Warsaw, Mazowieckie, Poland, 04-736
Centrum Onkologii-Instytut im. Marii Sklodowskiej-Curie
Warsaw, Mazowieckie, Poland, 02-781
Mazowieckie Centrum Leczenia Chorob Pluc
Otwock, Poland, 05-400
Russian Federation
City Hospital #2 Krasnodar Multi-Field Diagnostic and Treatment Association
Krasnodar, Krasnodarskij Kraj, Russian Federation, 350012
Oncology Center # 2
Sochi, Krasnodarskij Kraj, Russian Federation, 354057
Pyatigorsk Oncology Center
Pyatigorsk, Russian Federation, 357502
Clinic of Hospital Surgery
Saint-Petersburg, Russian Federation, 194044
City Clinical Oncology Dispensary
Saint-Petersburg, Russian Federation, 197022
City Clinical Oncology Dispensary
Saint-Petersburg, Russian Federation, 198255
Military Medical Academy n.a. S.M.Kirov
Saint-Petersburg, Russian Federation, 194044
Research Institute of Pulmonology
Saint-Petersburg, Russian Federation, 197089
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
Slovakia
Univerzitna Nemocnica Bratislava, Klinika pneumologie a ftizeologie I- Oddelenie klinickej onkologie
Bratislava, Slovakia, 826 06
Specializovana nemocnica sv. Svorada Zobor, n.o.
Nitra, Slovakia, 949 88
Fakultna nemocnica s poliklinikou
Nove Zamky, Slovakia, 94034
South Africa
GVI Oncology Clinical Research Unit
Kraaifontein, Western Cape, South Africa, 7570
Department of Oncotherapy
Bloemfontein, South Africa, 9301
WCR: Wits Clinical Research
Johannesburg, South Africa, 2193
GVI Oncology
Port Elizabeth, South Africa, 6045
Spain
Hospital General Universitario de Elche - Edificio UIAE
Elche, Alicante, Spain, 03203
Hospital Universitari Germans Trias i Pujol
Badalona, Barcelona, Spain, 08916
Hospital Provincial de Castellon - Servicio de Oncologia
Castellón, Castellon, Spain, 12002
Hospital de la Santa Creu i Sant Pau
Barcelona, Spain, 08041
Hospital de la Santa Creu i Sant Pau - AGDAC
Barcelona, Spain, 08041
Hospital de la Santa Creu i Sant Pau - Anatomia Patológica
Barcelona, Spain, 08041
Hospital de la Santa Creu i Sant Pau - Diagnostic per la Imatge i Med. Nuclear
Barcelona, Spain, 08041
HOSPITAL DE LA SANTA CREU I SANT PAU - Pharmacy
Barcelona, Spain, 08025
Hospital de la Santa Creu i Sant Pau - Hospital de Día
Barcelona, Spain, 08041
Hospital Provincial de Castellon (Farmacia)
Castellon, Spain
Hospital Universitario 12 de Octubre-Radiology
Madrid, Spain, 28041
Hospital Universitario 12 de Octubre01
Madrid, Spain, 28041
Hospital Universitario Madrid Sanchinarro
Madrid, Spain, 28050
Hospital Universitario Virgen del Rocio - PI
Sevilla, Spain, 41013
Laboratorio General - Hospital Virgen del Rocio - Edificio de Laboratorios
Sevilla, Spain, 41013
Laboratorio Urgencias - Hospital Virgen del Rocio - Edificio de Laboratorios
Sevilla, Spain, 41013
Sweden
KPE/Onkologikliniken
Karlstad, Sweden, 651 85
Karolinska Universitetssjukhuset
Stockholm, Sweden, 171 76
Switzerland
Kantonsspital Aarau
Aarau, Switzerland, 5001
Istituto Oncologico della Svizzera Italiana
Bellinzona, Switzerland, 06500
Hopitaux Universitaires de Geneve
Geneve 14, Switzerland, 1211
Ospedale Regionale di Locarno La Carita
Locarno, Switzerland, 06600
Kantonsspital St. Gallen
St. Gallen, Switzerland, 9007
United Kingdom
Kent Oncology Centre
Maidstone, Kent, United Kingdom, ME16 9QQ
North Middlesex NHS Trust
Edmonton, United Kingdom, N18 IQX
University of Leicester School of Medicine
Leicester, United Kingdom, LE1 5WW
Oncology Research, Podium,
London, United Kingdom, N18 1QX
North Middlesex NHS Trust
London, United Kingdom, N18 1QX
Cancer Clinical Trials Unit
London, United Kingdom, NW1 2PQ
Christie Hospital NHS Trust
Manchester, United Kingdom, M20 4BX
Christie Hospital NHS Trust, Department of Medical Oncology
Manchester, United Kingdom, M20 4BX
Lung and Melanoma Research Team
Manchester, United Kingdom, M20 4BX
The Royal Wolverhampton Hospitals NHS Trust
Wolverhampton, United Kingdom, WV10 0QP
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: NCT01360554     History of Changes
Other Study ID Numbers: A7471009, 2010-022656-22
Study First Received: April 12, 2011
Last Updated: April 30, 2015
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
comparative study of PF-00299804 and Erlotinib
Double-Blind Phase 3 trial of TKI

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Bronchial Neoplasms
Carcinoma, Bronchogenic
Lung Diseases
Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms
Erlotinib
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protein Kinase Inhibitors

ClinicalTrials.gov processed this record on May 26, 2015