Lung Cancer Clinical Trial

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

Summary

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.

View Eligibility Criteria

Eligibility 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.

Study is for people with:

Lung Cancer

Phase:

Phase 3

Estimated Enrollment:

878

Study ID:

NCT01360554

Recruitment Status:

Completed

Sponsor:

Pfizer

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There are 180 Locations for this study

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University of Alabama at Birmingham
Birmingham Alabama, 35233, United States
University of Alabama at Birmingham
Birmingham Alabama, 35249, United States
University of Alabama at Birmingham
Birmingham Alabama, 35294, United States
Northwest Alabama Cancer Center
Florence Alabama, 35630, United States
University of South Alabama Mitchell Cancer Institute
Mobile Alabama, 36604, United States
University of South Alabama Medical Center
Mobile Alabama, 36617, United States
Northwest Alabama Cancer Center
Muscle Shoals Alabama, 35661, United States
Ironwood physicians P C dba Ironwood Cancer & Research Centers
Chandler Arizona, 85224, United States
Ironwood Physicians P.C. dba Ironwood Cancer and Research Centers
Chandler Arizona, 85224, United States
Ironwood Physicians P.C. dba Ironwood Cancer and Research Centers
Gilbert Arizona, 85297, United States
Desert Oncology Associates dba Ironwood Cancer and Research Centers
Mesa Arizona, 85202, United States
Ironwood Physicians P.C. dba Ironwood Cancer and Research Centers
Mesa Arizona, 85206, United States
Highlands Oncology Group PA
Fayetteville Arkansas, 72703, United States
Highlands Oncology Group, PA
Rogers Arkansas, 72758, United States
Central Hematology Oncology Medical Group Inc.
Alhambra California, 91801, United States
UCLA Hematology Oncology-Alhambra
Alhambra California, 91801, United States
City of Hope
Duarte California, 91010, United States
St. Jude Heritage Healthcare
Fullerton California, 92835, United States
Drug Management Only
Los Angeles California, 90095, United States
Drug Managerrent Only:
Los Angeles California, 90095, United States
UCLA West Medical Pharmacy
Los Angeles California, 90095, United States
Administrative Address: UCLA Hematology Oncology-Clinical Research Unit (CRU)
Los Angeles California, 90095, United States
Drug Shipment Address: Ronald Reagan UCLA Medical Center, Drug Information Center
Los Angeles California, 90095, United States
Regulatory Management Only:
Los Angeles California, 90095, United States
Regulatory Management:
Los Angeles California, 90095, United States
Ronald Reagan UCLA Medical Center
Los Angeles California, 90095, United States
TORI Central Administration
Los Angeles California, 90095, United States
Westwood Bowyer Clinic, Peter Morton Medical Building
Los Angeles California, 90095, United States
UCLA/Pasadena Healthcare Hematology-Oncology
Pasadena California, 91105, United States
Central Hematology Oncology Medical Group, Inc.
Pasadena California, 91107, United States
Cancer Care Associates Medical Group Inc.
Redondo Beach California, 90277, United States
Central Coast Medical Oncology Corporation
Santa Maria California, 93454, United States
UCLA Hematology Oncology-Parkside
Santa Monica California, 90404, United States
UCLA Hematology Oncology-Santa Monica
Santa Monica California, 90404, United States
UCLA Santa Monica Medical Center & Orthopedic Hospital
Santa Monica California, 90404, United States
City of Hope South Pasadena Cancer Center
South Pasadena California, 91030, United States
UCLA/Santa Clarita Valley Cancer Center
Valencia California, 91355, United States
UCLA Cancer Center
Westlake Village California, 91361, United States
Norwalk Hospital
Norwalk Connecticut, 06856, United States
Florida Hospital
Orlando Florida, 32803, United States
Cancer Institute of Florida
Orlando Florida, 32804, United States
Hematology and Oncology Consultants, P.A.
Orlando Florida, 32804, United States
Investigational Drug Services, Florida Hospital
Orlando Florida, 32804, United States
Hematology Oncology Associates of the Treasure Coast
Port Saint Lucie Florida, 34952, United States
Emory University Hospital Midtown
Atlanta Georgia, 30308, United States
Emory Clinic
Atlanta Georgia, 30322, United States
Emory University Hospital
Atlanta Georgia, 30322, United States
Winship Cancer Institute of Emory University
Atlanta Georgia, 30322, United States
Northwest Georgia Oncology Centers, P.C.
Austell Georgia, 30106, United States
Northwest Georgia Oncology Centers, P.C.
Carrollton Georgia, 30117, United States
Northwest Georgia Oncology Centers, PC
Cartersville Georgia, 30121, United States
John B. Amos Cancer Center
Columbus Georgia, 31904, United States
Atlanta Cancer Care
Decatur Georgia, 30033, United States
Georgia Cancer Specialists
Decatur Georgia, 30033, United States
The Cancer Center at DeKalb Medical
Decatur Georgia, 30033, United States
Northwest Georgia Oncology Centers, P.C.
Douglasville Georgia, 30134, United States
Suburban Hematology-Oncology Associates, P.C.
Duluth Georgia, 30096, United States
Northeast Georgia Medical Center
Gainesville Georgia, 30501, United States
Oncology Specialists of North Georgia, LLC
Gainesville Georgia, 30501, United States
The Longstreet Clinic Cancer Center
Gainesville Georgia, 30501, United States
Suburban Hematology-Oncology Associates, P.C.
Lawrenceville Georgia, 30046, United States
Northwest Georgia Oncology Centers, P.C.
Marietta Georgia, 30060, United States
Suburban Hematology-Oncology Associates, P.C.
Snellville Georgia, 30078, United States
Illinois Cancer Specialists
Arlington Heights Illinois, 60005, United States
Ingalls Memorial Hospital - In-Patient Pharmacy
Harvey Illinois, 60426, United States
Ingalls Memorial Hospital
Harvey Illinois, 60426, United States
Monroe Medical Associates
Harvey Illinois, 60426, United States
Illinois Cancer Specialists
Niles Illinois, 60714, United States
Monroe Medical Associates
Tinley Park Illinois, 60477, United States
Deaconess Clinic Downtown
Evansville Indiana, 47713, United States
Monroe Medical Associates
Munster Indiana, 46321, United States
Cedar Valley Medical Specialists, P.C.
Waterloo Iowa, 50701, United States
Kentucky Cancer Clinic
Hazard Kentucky, 41701, United States
University Medical Center, Inc.
Louisville Kentucky, 40202, United States
University Medical Center, Inc
Louisville Kentucky, 40202, United States
Baptist Hospital East
Louisville Kentucky, 40207, United States
Karmanos Cancer Institute
Detroit Michigan, 48201, United States
Karmanos Cancer Institute at Farmington Hills
Farmington Hills Michigan, 48334, United States
North Mississippi Hematology and Oncology Associates, Ltd.
Starkville Mississippi, 39759, United States
North Mississippi Hematology and Oncology Associates, Ltd.,
Tupelo Mississippi, 38801, United States
Siteman Cancer Center-West County
Creve Coeur Missouri, 63141, United States
Barnes Jewish Hospital
Saint Louis Missouri, 63110, United States
Washington University School of Medicine-IDS Pharmacy
Saint Louis Missouri, 63110, United States
Siteman Cancer Center-St. Peters
Saint Peters Missouri, 63376, United States
Dartmouth-Hitchcock Medical Center /Mary Hitchcock Memorial Hospital
Lebanon New Hampshire, 03756, United States
Oncology and Hematology Specialists, P.A.
Denville New Jersey, 07834, United States
Stony Brook University-Cancer Center
Stony Brook New York, 11794, United States
Carolina Oncology Specialists PA
Hickory North Carolina, 28602, United States
Carolina Oncology Specialists PA
Lenoir North Carolina, 28645, United States
Mercy clinic oklahoma communities, Inc. - Mercy clinic oncology/Hematology - Norman
Norman Oklahoma, 73071, United States
Mercy Physicians of Oklahoma-Communities, Inc. - Mercy Clinic Oncology/Hematology - McAuley
Oklahoma City Oklahoma, 73120, United States
Mercy Hospital Oklahoma City - Oncology Infusion
Oklahoma City Oklahoma, 73120, United States
Good Samaritan Hospital Samaritan Ambulatory Infusion Services
Corvallis Oregon, 97330, United States
Samaritan Hematology & Oncology Consultants
Corvallis Oregon, 97330, United States
Samaritan Pharmacy Services
Corvallis Oregon, 97330, United States
Samaritan North Lincoln Hospital
Lincoln City Oregon, 97367, United States
Samaritan Pacific Communities Hospital
Newport Oregon, 97365, United States
Guthrie Clinic, Limited
Sayre Pennsylvania, 18840, United States
Robert Packer Hospital
Sayre Pennsylvania, 18840, United States
Texas Oncology-Longview Cancer Center
Longview Texas, 75601, United States
Texas Oncology-Tyler
Tyler Texas, 75702, United States
Texas Oncology - Waco
Waco Texas, 76712, United States
Kadlec Clinic Hematology and Oncology
Kennewick Washington, 99336, United States
Kadlec Medical Center
Richland Washington, 99352, United States
Outpatient Imaging Center
Richland Washington, 99352, United States
Seattle Cancer Care Alliance
Seattle Washington, 98109, United States
University of Washington Medical Center
Seattle Washington, 98195, United States
Sozialmedizinisches Zentrum Baumgartner Hoehe - Otto Wagner Spital und Pflegezentrum
Vienna , 1140, Austria
Institut Jules Bordet
Brussels , 1000, Belgium
Laboratoire de la Porte de Hall
Brussels , 1000, Belgium
Grand Hopital de Charleroi Oncologie-Hematologie
Charleroi , 6000, Belgium
CHU Ambroise Parre- Service Biologie Clinique
Mons , 7000, Belgium
Heilig Hart Ziekenhuis Roeselare-Menen
Roeselare , 8800, Belgium
Tumour Hospital of Guangxi Zhuang Autonomous Region
Nanning Guangxi, 53002, China
Union Hospital, Tongji Medical College of Huazhong University of Science & Technology/Cancer Center
Wuhan Hubei, 43002, China
Jilin Provincial Cancer Hospital
Changchun Jilin, 13001, China
West China Hospital of Sichuan University
Chengdu Sichuan, 61004, China
Shanghai Pulmonary Hospital
Shanghai , 20043, China
Aalborg Sygehus Syd
Aalborg , 9100, Denmark
Helsingin yliopistollinen sairaala, Meilahden kolmiosairaala, keuhkosairauksien poliklinikka
Helsinki , 00290, Finland
Satakunnan keskussairaala/Keuhkosairauksien osasto A4
Pori , 28500, Finland
Centre Georges Francois Leclerc
Dijon , 21079, France
Hopital Albert Michallon
Grenoble cedex 09 , 38043, France
Hôpital Paris Saint Joseph
Paris , 75014, France
CHU de Poitiers
Poitiers Cedex , 86021, France
Institut de Cancerologie de lOuest - Rene Gauducheau
Saint Herblain cedex , 44805, France
Universitaetsklinikum Aachen
Aachen , 52074, Germany
Asklepios Fachkliniken Muenchen-Gauting
Gauting , 82131, Germany
Lungenfachklinik Immenhausen
Immenhausen , 34376, Germany
Universitaetsmedizin der Johannes Gutenberg-Universitaet
Mainz , 55131, Germany
Krankenhaus Bethanien, Medizinische Klinik III
Moers , 47441, Germany
University Hospital of Larissa
Larissa Thessaly, 41110, Greece
Sotiria General Hospital of Athens
Athens , 11527, Greece
University Hospital of Heraklion
Heraklion , 71110, Greece
Semmelweis Egyetem Pulmonologiai Klinika
Budapest , 1125, Hungary
Debreceni Egyetem Orvos- es Egeszsegtudomanyi Centrum
Debrecen , 4032, Hungary
Veszprem Megyei Onkormanyzat Tudogyogyintezete
Farkasgyepu , 8582, Hungary
Pandy Kalman Megyei Korhaz, Aktiv Tudogyogyaszat
Gyula , 5703, Hungary
Josa Andras Oktatokorhaz Egeszsegugyi Szolgaltato Nonprofit Kft.
Nyiregyhaza , 4412, Hungary
Zala Megyei Korhaz, Pulmonologiai Osztaly
Zalaegerszeg-Pozva , 8900, Hungary
Vedanta Institute of Medical Sciences
Ahmedabad Gujarat, 380 0, India
Manipal Hospital
Bangalore Karnataka, 56001, India
Tata Memorial Centre
Mumbai Maharashtra, 40001, India
Ruby Hall Clinic
Pune Maharastra, 41100, India
St Vincent's University Hospital
Dublin Leinster, Dubli, Ireland
Beaumont Hospital
Dublin Leinster, Dubli, Ireland
St. James Hospital
Dublin , 8, Ireland
Oncology Department
Waterford , , Ireland
Aichi cancer center central hospital /Thoracic Oncology
Nagoya Aichi, 464-8, Japan
National Cancer Center Hospital East
Kashiwa Chiba, 277-8, Japan
National Hospital Organization Shikoku Cancer Center
Matsuyama-city Ehime, 791-0, Japan
National Hospital Organization Asahikawa Medical Center
Asahikawa Hokkaido, 070-8, Japan
Hyogo Cancer Center
Akashi Hyogo, 673-8, Japan
Kanazawa University Hospital
Kanazawa city Ishikawa, 92086, Japan
Kanagawa Cardiovascular and Respiratory Center
Yokohama Kanagawa, 236-0, Japan
Tohoku University Hospital
Sendai Miyagi, 980-8, Japan
Kurashiki Central Hospital
Kurashiki Okayama, 710-8, Japan
Okayama University Hospital
Okayama-city Okayama, 700-8, Japan
National Hospital Organization Kinki-chuo Chest Medical Center
Sakai-Shi Osaka-fu, 591-8, Japan
Osaka City General Hospital Department of Clinical Oncology
Osaka-city Osaka, 534-0, Japan
Kinki University Hospital
Osakasayama-shi Osaka, 589-8, Japan
Shizuoka Cancer Center
Sunto-gun Shizuoka, 411-8, Japan
National Cancer Center Hospital
Chuo-Ku Tokyo, 104-0, Japan
National Hospital Organization, Yamaguchi-Ube Medical Center
Ube-shi Yamaguchi, 755-0, Japan
National Hp. Org. Kyushu Medical Center
Fukuoka , 810-8, Japan
National Hospital Organization Kyushu Cancer Center/Department of Thoracic Oncology
Fukuoka , 811-1, Japan
Kyushu University Hospital Respiratory Medicine
Fukuoka , 812-8, Japan
The Cancer Institute Hospital of JFCR
Koto-ku, Tokyo , 135-8, Japan
Seoul National University Hospital
Seoul , 110-7, Korea, Republic of
Samsung Medical Center, Clinical Trial Center
Seoul , 135-7, Korea, Republic of
Asan Medical Center, Department of Oncology
Seoul , 138-7, Korea, Republic of
Oaxaca Site Management Organization
Oaxaca , 68000, Mexico
Mazowieckie Centrum Leczenia Chorob Pluc i Gruzlicy
Otwock Mazowieckie, 05-40, Poland
Zoz All-Medi
Otwock Mazowieckie, 05-40, Poland
Centrum Onkologii-Instytut im. Marii Sklodowskiej-Curie
Warsaw Mazowieckie, 02-78, Poland
Nukleomed
Warsaw Mazowieckie, 04-73, Poland
City Hospital #2 Krasnodar Multi-Field Diagnostic and Treatment Association
Krasnodar Krasnodarskij Kraj, 35001, Russian Federation
Oncology Center # 2
Sochi Krasnodarskij Kraj, 35405, Russian Federation
Federal State Healthcare Clinical Hospital #101 of the Federal Biomedical Agency
Pyatigorsk Stavropolskij Kraj, 35734, Russian Federation
Pyatigorsk Oncology Center
Pyatigorsk , 35750, Russian Federation
Clinic of Hospital Surgery
Saint-Petersburg , 19404, Russian Federation
Military Medical Academy n.a. S.M.Kirov
Saint-Petersburg , 19404, Russian Federation
City Clinical Oncology Dispensary
Saint-Petersburg , 19702, Russian Federation
St.-Petersburg State Medical University I.P.Pavlov of Roszdrav
Saint-Petersburg , 19702, Russian Federation
Research Institute of Pulmonology
Saint-Petersburg , 19708, Russian Federation
Russian Scientific Center of Radiology and Surgical Technologies
Saint-Petersburg , 19775, Russian Federation
City Clinical Oncology Dispensary
Saint-Petersburg , 19825, Russian Federation
Samara Regional Clinical Oncology Dispensary
Samara , 44303, Russian Federation
Univerzitna Nemocnica Bratislava, Klinika pneumologie a ftizeologie I- Oddelenie klinickej onkologie
Bratislava , 826 0, Slovakia
Specializovana nemocnica sv. Svorada Zobor, n.o.
Nitra , 949 8, Slovakia
Fakultna nemocnica s poliklinikou
Nove Zamky , 94034, Slovakia
WCR: Wits Clinical Research
Parktown,Johannesburg Gauteng, 2193, South Africa
GVI Oncology Clinical Research Unit
Kraaifontein Western Cape, 7570, South Africa
Department of Oncotherapy
Bloemfontein , 9301, South Africa
GVI Oncology
Port Elizabeth , 6045, South Africa
Hospital General Universitario de Elche - Edificio UIAE
Elche Alicante, 03203, Spain
Hospital Universitari Germans Trias i Pujol
Badalona Barcelona, 08916, Spain
Hospital Provincial de Castellon - Servicio de Oncologia
Castellón Castellon, 12002, Spain
HOSPITAL DE LA SANTA CREU I SANT PAU - Pharmacy
Barcelona , 08025, Spain
Hospital de la Santa Creu i Sant Pau - AGDAC
Barcelona , 08041, Spain
Hospital de la Santa Creu i Sant Pau - Anatomia Patológica
Barcelona , 08041, Spain
Hospital de la Santa Creu i Sant Pau - Diagnostic per la Imatge i Med. Nuclear
Barcelona , 08041, Spain
Hospital de la Santa Creu i Sant Pau - Hospital de Día
Barcelona , 08041, Spain
Hospital de la Santa Creu i Sant Pau
Barcelona , 08041, Spain
Hospital Provincial de Castellon (Farmacia)
Castellon , , Spain
Hospital Universitario 12 de Octubre-Radiology
Madrid , 28041, Spain
Hospital Universitario 12 de Octubre01
Madrid , 28041, Spain
Hospital Universitario Madrid Sanchinarro
Madrid , 28050, Spain
Hospital Universitario Virgen del Rocio. Hospital General Planta Baja. Servicio de Oncologia.
Sevilla , 41013, Spain
KPE/Onkologikliniken
Karlstad , 651 8, Sweden
Karolinska Universitetssjukhuset
Stockholm , 171 7, Sweden
Kantonsspital Aarau
Aarau , 5001, Switzerland
Istituto Oncologico della Svizzera Italiana
Bellinzona , 06500, Switzerland
Hopitaux Universitaires de Geneve
Geneve 14 , 1211, Switzerland
Ospedale Regionale di Locarno La Carita
Locarno , 06600, Switzerland
Kantonsspital St. Gallen
St. Gallen , 9007, Switzerland
Kent Oncology Centre
Maidstone Kent, ME16 , United Kingdom
New Cross Hospital - Royal Wolverhampton Hospital NHS Trust
Wolverhampton West Midlands, WV10 , United Kingdom
North Middlesex NHS Trust
Edmonton , N18 1, United Kingdom
Leicester Royal Infirmary
Leicester , LE1 5, United Kingdom
Cancer Clinical Trials Unit
London , NW1 2, United Kingdom
Christie Hospital NHS Trust, Department of Medical Oncology
Manchester , M20 4, United Kingdom
Christie Hospital NHS Trust
Manchester , M20 4, United Kingdom
Lung and Melanoma Research Team
Manchester , M20 4, United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Lung Cancer

Phase:

Phase 3

Estimated Enrollment:

878

Study ID:

NCT01360554

Recruitment Status:

Completed

Sponsor:


Pfizer

How clear is this clinincal trial information?

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