This site became the new ClinicalTrials.gov on June 19th. Learn more.
Show more
ClinicalTrials.gov Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu
Give us feedback
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 (ARCHER 1009)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01360554
First received: April 12, 2011
Last updated: April 24, 2017
Last verified: April 2017
  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 Drug: Dacomitinib (PF-00299804) Drug: Active Comparator (erlotinib) Drug: Placebo erlotinib Drug: Placebo PF00299804 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Care Provider, 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 (PFS) Per Independent Radiologic Review. [ Time Frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, participants were followed up until progressive disease regardless of start of subsequent cancer therapy. ]
    PFS was defined as the time from randomization to the date of disease progression as by Response Evaluation Criteria in Solid Tumor (RECIST) v1.1 per Independent Radiologic Review or death due to any cause, whichever occurred first. Objective progression was defined as a 20% increase in the sum of the diameters of target measurable lesions above the smallest sum observed (over baseline if no decrease in the sum is observed during therapy), with a minimum absolute increase of 5 mm or unequivocal progression of pre-existing non-target lesions, or the appearance of any new unequivocal malignant lesions.

  • Progression-Free Survival (PFS) Per Independent Radiologic Review in KRAS Wild-type (WT) Participants. [ Time Frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, participants were followed up until progressive disease regardless of start of subsequent cancer therapy. ]
    PFS was defined as the time from randomization to the date of disease progression as by RECIST v1.1 per Independent Radiologic Review or death due to any cause, whichever occurred first. Objective progression was defined as a 20% increase in the sum of the diameters of target measurable lesions above the smallest sum observed (over baseline if no decrease in the sum is observed during therapy), with a minimum absolute increase of 5 mm or unequivocal progression of pre-existing non-target lesions, or the appearance of any new unequivocal malignant lesions. Tumor tissue from participants' original diagnostic biopsies or recently obtained biopsies were analyzed to determine KRAS status.


Secondary Outcome Measures:
  • PFS Based on Investigator Review. [ Time Frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, participants were followed up until progressive disease regardless of start of subsequent cancer therapy. ]
    PFS was defined as the time from randomization to the date of disease progression as by RECIST v1.1 per Investigator's Review or death due to any cause, whichever occurred first. Objective progression was defined as a 20% increase in the sum of the diameters of target measurable lesions above the smallest sum observed (over baseline if no decrease in the sum is observed during therapy), with a minimum absolute increase of 5 mm or unequivocal progression of pre-existing non-target lesions, or the appearance of any new unequivocal malignant lesions.

  • PFS Based on Investigator Review in KRAS-WT Participants. [ Time Frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, participants were followed up until progressive disease regardless of start of subsequent cancer therapy. ]
    PFS was defined as the time from randomization to the date of disease progression as by RECIST v1.1 per Investigator's Review or death due to any cause, whichever occurred first. Objective progression was defined as a 20% increase in the sum of the diameters of target measurable lesions above the smallest sum observed (over baseline if no decrease in the sum is observed during therapy), with a minimum absolute increase of 5 mm or unequivocal progression of pre-existing non-target lesions, or the appearance of any new unequivocal malignant lesions. Tumor tissue from participants' original diagnostic biopsies or recently obtained biopsies were analyzed to determine KRAS status.

  • Overall Survival (OS). [ Time Frame: From date of randomization until the date of death from any cause or last date known to be alive, participants were followed up regardless of the reason for discontinuation from study treatment at intervals of no longer than every 2 months. ]
    OS was defined as the time from randomization to the date of death for any cause. In the absence of confirmation of death, survival time was censored at the last date the patient was known to be alive (ie, at their last known alive date from long term follow-up).

  • OS in KRAS-WT Participants. [ Time Frame: From date of randomization until the date of death from any cause or last date known to be alive, participants were followed up regardless of the reason for discontinuation from study treatment at intervals of no longer than every 2 months. ]
    OS was defined as the time from randomization to the date of death for any cause. In the absence of confirmation of death, survival time was censored at the last date the patient was known to be alive (ie, at their last known alive date from long term follow-up). Tumor tissue from participants' original diagnostic biopsies or recently obtained biopsies were analyzed to determine KRAS status.

  • Best Overall Response (BOR) Per Independent Radiologic Review. [ Time Frame: From date of randomization until progression or initiation of new anti-cancer therapy or death. Participants were followed up until progressive disease regardless of start of subsequent cancer therapy. ]
    The BOR was the best response per RECIST (version 1.1) criteria as assessed by independent assessment recorded from randomization until disease progression. Per RECIST version 1.1: Complete Response (CR): disappearance of all pre-existing lesions except nodal disease, with all nodal lesions decreased to normal size (short axis<10 mm) and no appearance of new unequivocal malignant lesions; Partial Response (PR): >=30% decrease from baseline sum of diameters of all target lesions with no unequivocal progression of pre-existing non-target lesions or appearance of new unequivocal malignant lesions; Progressive Disease (PD): >=20% increase in the sum of diameters of target lesions above the smallest sum observed, with a minimum absolute increase of 5 mm, or unequivocal progression of pre-existing non-target lesions or appearance of any new unequivocal malignant lesions.

  • BOR Per Investigator Review. [ Time Frame: From date of randomization until progression or initiation of new anti-cancer therapy or death. Participants were followed up until progressive disease regardless of start of subsequent cancer therapy. ]
    The BOR was the best response per RECIST (version 1.1) criteria as assessed by investigator assessment recorded from randomization until disease progression. Per RECIST version 1.1: CR: disappearance of all pre-existing lesions except nodal disease, with all nodal lesions decreased to normal size (short axis<10 mm) and no appearance of new unequivocal malignant lesions; PR: >=30% decrease from baseline sum of diameters of all target lesions with no unequivocal progression of pre-existing non-target lesions or appearance of new unequivocal malignant lesions; PD: >=20% increase in the sum of diameters of target lesions above the smallest sum observed, with a minimum absolute increase of 5 mm, or unequivocal progression of pre-existing non-target lesions or appearance of any new unequivocal malignant lesions.

  • Duration of Response (DR) Based on Independent Radiologic Review. [ Time Frame: From date of randomization until progression or death due to any cause. Participants were followed up until progressive disease regardless of start of subsequent cancer therapy. ]
    DR was defined as the time from first documentation of response assessed by independent review (CR or PR whichever occurred first) to date of progression or death due to any cause, whichever occurs first. Per RECIST version 1.1: CR: disappearance of all pre-existing lesions except nodal disease, with all nodal lesions decreased to normal size (short axis<10 mm) and no appearance of new unequivocal malignant lesions; PR: >=30% decrease from baseline sum of diameters of all target lesions with no unequivocal progression of pre-existing non-target lesions or appearance of new unequivocal malignant lesions; PD: >=20% increase in the sum of diameters of target lesions above the smallest sum observed, with a minimum absolute increase of 5 mm, or unequivocal progression of pre-existing non-target lesions or appearance of any new unequivocal malignant lesions.

  • DR Based on Investigator Review. [ Time Frame: From date of randomization until progression or death due to any cause. Participants were followed up until progressive disease regardless of start of subsequent cancer therapy. ]
    DR was defined as the time from first documentation of response assessed by investigator review (CR or PR whichever occurred first) to date of progression or death due to any cause, whichever occurs first. Per RECIST version 1.1: CR: disappearance of all pre-existing lesions except nodal disease, with all nodal lesions decreased to normal size (short axis<10 mm) and no appearance of new unequivocal malignant lesions; PR: >=30% decrease from baseline sum of diameters of all target lesions with no unequivocal progression of pre-existing non-target lesions or appearance of new unequivocal malignant lesions; PD: >=20% increase in the sum of diameters of target lesions above the smallest sum observed, with a minimum absolute increase of 5 mm, or unequivocal progression of pre-existing non-target lesions or appearance of any new unequivocal malignant lesions.

  • Trough Concentrations (Ctrough) of Dacomitinib. [ Time Frame: Baseline up to Cycle 5 Day 1 ]
    Mean Ctrough values of dacomitinib observed from Cycle 2 through 5, Day 1 for dose compliant participants.

  • Trough Concentrations (Ctrough) of PF-05199265. [ Time Frame: Baseline up to Cycle 5 Day 1 ]
    Mean Ctrough values of PF-05199265 observed from Cycle 2 through 5, Day 1 for dose compliant participants.

  • Time to Deterioration (TTD) in Pain, Dyspnea, Fatigue or Cough Patient Reported Disease Symptoms. [ Time Frame: Data taken from Cycle 1 day 1 to the end of treatment or withdrawal. ]
    TTD defined as the time from first dose (baseline) to the first time a patient's score in pain, dyspnea, fatigue or cough from the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (QLQ-LC13) increased by ≥10 points. A ≥10 point increase in score had to be maintained for ≥2 consecutive cycles for the symptom to be considered deteriorated. Participants were censored at the last time when they completed an assessment for pain, dyspnea, fatigue or cough if they had not deteriorated. A 10 point or higher change in the score is perceived by participants as clinically significant.

  • Mean and Difference in Mean in Functioning and Global Quality of Life (QOL) as Assessed by the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC-QLQ-C30) [ Time Frame: Data taken from Cycle 1 day 1 to the end of treatment or withdrawal, averaged (mean) to provide overall scores. ]
    EORTC QLQ-C30: included functional scales (physical, role, cognitive, emotional, and social), global health status, symptom scales (fatigue, pain, nausea/vomiting) and single items (dyspnoea, appetite loss, insomnia, constipation/diarrhea and financial difficulties). Scores ranged from 0-100 where a higher score indicated a better level of quality of life. Overall scores present the mean score for that scale from all time-point data.

  • Mean and Difference in Mean in QLQ-C30 Symptoms as Assessed by the EORTC-QLQ-C30. [ Time Frame: Data taken from Cycle 1 day 1 to the end of treatment or withdrawal, averaged (mean) to provide overall scores. ]
    EORTC QLQ-C30: included functional scales (physical, role, cognitive, emotional, and social), global health status, symptom scales (fatigue, pain, nausea/vomiting) and single items (dyspnoea, appetite loss, insomnia, constipation/diarrhea and financial difficulties). Scores ranged from 0-100 where a higher score indicated a greater degree of symptoms/problems. Overall scores present the mean score for that scale from all time-point data.

  • Mean and Difference in Mean in Lung Cancer Symptom Scores as Assessed by the EORTC QLQ- LC13. [ Time Frame: Data taken from Cycle 1 day 1 to the end of treatment or withdrawal, averaged (mean) to provide overall scores. ]
    The QLQ-LC13 included questions specific to the disease associated symptoms (dyspnea, cough, haemoptysis, and site specific pain), treatment-related symptoms (sore mouth, dysphagia, neuropathy, and alopecia), and analgesic use of lung cancer patients. Scores range from 0-100 and a higher score indicates greater degree of symptoms/problems. Overall scores present the mean score for that scale from all time-point data.

  • Mean and Difference in Mean of the EuroQoL-5 Dimensions (EQ-5D) Visual Analogue Scale (VAS) Score [ Time Frame: Data taken from Cycle 1 day 1 to the end of treatment or withdrawal, averaged (mean) to provide overall scores. ]
    The EQ-5D is a validated and reliable self-report preference-based measure developed by the EuroQoL Group to assess health-related quality of life. It consists of the EQ-5D descriptive system and a visual analogue scale-the EQ VAS. The EQ-5D descriptive system measures a participants' health state on 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 3 levels, reflecting "no health problems," "moderate health problems," and "extreme health problems." The EQ VAS records the respondent's self-rated health on a scale from 0 (worst imaginable health state) to 100 (best imaginable health state).


Enrollment: 878
Study Start Date: June 16, 2011
Study Completion Date: September 14, 2015
Primary Completion Date: September 30, 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
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   (Adult, Senior)
Sexes Eligible for Study:   All
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
Birmingham, Alabama, United States, 35233
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35249
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
Northwest Alabama Cancer Center
Florence, Alabama, United States, 35630
University of South Alabama Mitchell Cancer Institute
Mobile, Alabama, United States, 36604
University of South Alabama Medical Center
Mobile, Alabama, United States, 36617
Northwest Alabama Cancer Center
Muscle Shoals, Alabama, United States, 35661
United States, Arizona
Ironwood physicians P C dba Ironwood Cancer & Research Centers
Chandler, Arizona, United States, 85224
Ironwood Physicians P.C. dba Ironwood Cancer and Research Centers
Chandler, Arizona, United States, 85224
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, 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
Drug Management Only
Los Angeles, California, United States, 90095-1772
Drug Managerrent Only:
Los Angeles, California, United States, 90095-1772
UCLA West Medical Pharmacy
Los Angeles, California, United States, 90095-1772
Administrative Address: UCLA Hematology Oncology-Clinical Research Unit (CRU)
Los Angeles, California, United States, 90095
Drug Shipment Address: Ronald Reagan UCLA Medical Center, Drug Information Center
Los Angeles, California, United States, 90095
Regulatory Management Only:
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
TORI Central Administration
Los Angeles, California, United States, 90095
Westwood Bowyer Clinic, Peter Morton Medical Building
Los Angeles, California, United States, 90095
UCLA/Pasadena Healthcare Hematology-Oncology
Pasadena, California, United States, 91105
Central Hematology Oncology Medical Group, Inc.
Pasadena, California, United States, 91107
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
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
Cancer Institute of Florida
Orlando, Florida, United States, 32804
Hematology and Oncology Consultants, P.A.
Orlando, Florida, United States, 32804
Investigational Drug Services, Florida Hospital
Orlando, Florida, United States, 32804
Hematology Oncology Associates of the Treasure Coast
Port Saint Lucie, Florida, United States, 34952
United States, Georgia
Emory University Hospital Midtown
Atlanta, Georgia, United States, 30308
Emory Clinic
Atlanta, Georgia, United States, 30322
Emory University Hospital
Atlanta, Georgia, United States, 30322
Winship Cancer Institute of Emory University
Atlanta, Georgia, United States, 30322
Northwest Georgia Oncology Centers, P.C.
Austell, Georgia, United States, 30106
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
Atlanta Cancer Care
Decatur, Georgia, United States, 30033
Georgia Cancer Specialists
Decatur, Georgia, United States, 30033
The Cancer Center at DeKalb Medical
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
Northeast Georgia Medical Center
Gainesville, Georgia, United States, 30501
Oncology Specialists of North Georgia, LLC
Gainesville, Georgia, United States, 30501
The Longstreet Clinic Cancer Center
Gainesville, Georgia, United States, 30501
Suburban Hematology-Oncology Associates, P.C.
Lawrenceville, Georgia, United States, 30046
Northwest Georgia Oncology Centers, P.C.
Marietta, Georgia, United States, 30060
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 - In-Patient Pharmacy
Harvey, Illinois, United States, 60426
Ingalls Memorial Hospital
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
University Medical Center, Inc.
Louisville, Kentucky, United States, 40202
University Medical Center, Inc
Louisville, Kentucky, United States, 40202
Baptist Hospital East
Louisville, Kentucky, United States, 40207
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.
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
Barnes Jewish Hospital
Saint Louis, Missouri, United States, 63110-1094
Washington University School of Medicine-IDS Pharmacy
Saint Louis, Missouri, United States, 63110
Siteman Cancer Center-St. Peters
Saint 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-Cancer Center
Stony Brook, New York, United States, 11794-9447
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 Physicians of Oklahoma-Communities, Inc. - Mercy Clinic Oncology/Hematology - McAuley
Oklahoma City, Oklahoma, United States, 73120-8347
Mercy Hospital Oklahoma City - Oncology Infusion
Oklahoma City, Oklahoma, United States, 73120
United States, Oregon
Good Samaritan Hospital Samaritan Ambulatory Infusion Services
Corvallis, Oregon, United States, 97330
Samaritan Hematology & 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
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
Kadlec Clinic Hematology and Oncology
Kennewick, Washington, United States, 99336
Kadlec Medical Center
Richland, Washington, United States, 99352
Outpatient Imaging Center
Richland, Washington, United States, 99352
Seattle Cancer Care Alliance
Seattle, Washington, United States, 98109
University of Washington Medical Center
Seattle, Washington, United States, 98195
Austria
Sozialmedizinisches Zentrum Baumgartner Hoehe - Otto Wagner Spital und Pflegezentrum
Vienna, Austria, 1140
Belgium
Institut Jules Bordet
Brussels, Belgium, 1000
Laboratoire de la Porte de Hall
Brussels, Belgium, 1000
Grand Hopital de Charleroi Oncologie-Hematologie
Charleroi, Belgium, 6000
CHU Ambroise Parre- Service Biologie Clinique
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
Changchun, Jilin, China, 130012
China, Sichuan
West China Hospital of Sichuan University
Chengdu, Sichuan, China, 610041
China
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
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 Cancerologie de lOuest - Rene Gauducheau
Saint Herblain cedex, 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
University Hospital of Larissa
Larissa, Thessaly, Greece, 41110
Sotiria General Hospital of Athens
Athens, Greece, 11527
University Hospital of Heraklion
Heraklion, Greece, 71110
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
St Vincent's University Hospital
Dublin, Leinster, Ireland, Dublin 4
Beaumont Hospital
Dublin, Leinster, Ireland, Dublin 9
St. James Hospital
Dublin, Ireland, 8
Oncology Department
Waterford, Ireland
Japan
Aichi cancer center central hospital /Thoracic Oncology
Nagoya, Aichi, Japan, 464-8681
National Cancer Center Hospital East
Kashiwa, Chiba, Japan, 277-8577
National Hospital Organization Shikoku Cancer Center
Matsuyama-city, Ehime, Japan, 791-0280
National Hospital Organization Asahikawa Medical Center
Asahikawa, Hokkaido, Japan, 070-8644
Hyogo Cancer Center
Akashi, Hyogo, Japan, 673-8558
Kanazawa University Hospital
Kanazawa city, Ishikawa, Japan, 9208641
Kanagawa Cardiovascular and Respiratory Center
Yokohama, Kanagawa, Japan, 236-0051
Tohoku University Hospital
Sendai, Miyagi, Japan, 980-8574
Kurashiki Central Hospital
Kurashiki, Okayama, Japan, 710-8602
Okayama University Hospital
Okayama-city, Okayama, Japan, 700-8558
National Hospital Organization Kinki-chuo Chest Medical Center
Sakai-Shi, Osaka-fu, Japan, 591-8555
Osaka City General Hospital Department of Clinical Oncology
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 Hospital Organization, Yamaguchi-Ube Medical Center
Ube-shi, Yamaguchi, Japan, 755-0241
National Hp. Org. Kyushu Medical Center
Fukuoka, Japan, 810-8563
National Hospital Organization Kyushu Cancer Center/Department of Thoracic Oncology
Fukuoka, Japan, 811-1395
Kyushu University Hospital Respiratory Medicine
Fukuoka, Japan, 812-8582
The Cancer Institute Hospital of JFCR
Koto-ku, Tokyo, Japan, 135-8550
Korea, Republic of
Seoul National University Hospital
Seoul, Korea, Republic of, 110-744
Samsung Medical Center, Clinical Trial Center
Seoul, Korea, Republic of, 135-710
Asan Medical Center, Department of Oncology
Seoul, Korea, Republic of, 138-736
Mexico
Oaxaca Site Management Organization
Oaxaca, Mexico, 68000
Poland
Mazowieckie Centrum Leczenia Chorob Pluc i Gruzlicy
Otwock, Mazowieckie, Poland, 05-400
Zoz All-Medi
Otwock, Mazowieckie, Poland, 05-400
Centrum Onkologii-Instytut im. Marii Sklodowskiej-Curie
Warsaw, Mazowieckie, Poland, 02-781
Nukleomed
Warsaw, Mazowieckie, Poland, 04-736
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
Federal State Healthcare Clinical Hospital #101 of the Federal Biomedical Agency
Pyatigorsk, Stavropolskij Kraj, Russian Federation, 357340
Pyatigorsk Oncology Center
Pyatigorsk, Russian Federation, 357502
Clinic of Hospital Surgery
Saint-Petersburg, Russian Federation, 194044
Military Medical Academy n.a. S.M.Kirov
Saint-Petersburg, Russian Federation, 194044
City Clinical Oncology Dispensary
Saint-Petersburg, Russian Federation, 197022
St.-Petersburg State Medical University I.P.Pavlov of Roszdrav
Saint-Petersburg, Russian Federation, 197022
Research Institute of Pulmonology
Saint-Petersburg, Russian Federation, 197089
Russian Scientific Center of Radiology and Surgical Technologies
Saint-Petersburg, Russian Federation, 197758
City Clinical Oncology Dispensary
Saint-Petersburg, Russian Federation, 198255
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
WCR: Wits Clinical Research
Parktown,Johannesburg, Gauteng, South Africa, 2193
GVI Oncology Clinical Research Unit
Kraaifontein, Western Cape, South Africa, 7570
Department of Oncotherapy
Bloemfontein, South Africa, 9301
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 - Pharmacy
Barcelona, Spain, 08025
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 - Hospital de Día
Barcelona, Spain, 08041
Hospital de la Santa Creu i Sant Pau
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. Hospital General Planta Baja. Servicio de Oncologia.
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
New Cross Hospital - Royal Wolverhampton Hospital NHS Trust
Wolverhampton, West Midlands, United Kingdom, WV10 0QP
North Middlesex NHS Trust
Edmonton, United Kingdom, N18 1QX
Leicester Royal Infirmary
Leicester, United Kingdom, LE1 5WW
Cancer Clinical Trials Unit
London, United Kingdom, NW1 2PQ
Christie Hospital NHS Trust, Department of Medical Oncology
Manchester, United Kingdom, M20 4BX
Christie Hospital NHS Trust
Manchester, United Kingdom, M20 4BX
Lung and Melanoma Research Team
Manchester, United Kingdom, M20 4BX
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
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 ( EudraCT Number )
Study First Received: April 12, 2011
Results First Received: September 7, 2016
Last Updated: April 24, 2017

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

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

ClinicalTrials.gov processed this record on June 23, 2017