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: July 9, 2014
Last verified: July 2014
  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)
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: 800
Study Start Date: June 2011
Estimated Study Completion Date: September 2014
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 + placebo erlotinib, provided as 150 mg tablet, continuous oral daily dosing.
Other Name: Dacomitinib (PF-00299804)
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 + 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

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Locations
United States, Alabama
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Birmingham, Alabama, United States, 35294
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Birmingham, Alabama, United States, 35233
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Birmingham, Alabama, United States, 35249
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Florence, Alabama, United States, 35630
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Mobile, Alabama, United States, 36604
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Mobile, Alabama, United States, 36617
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Muscle Shoals, Alabama, United States, 35661
United States, Arizona
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Chandler, Arizona, United States, 85224
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Chandler, Arizona, United States, 85524
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Gilbert, Arizona, United States, 85297
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Mesa, Arizona, United States, 85206
United States, Arkansas
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Bentonville, Arkansas, United States, 72758
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Fayetteville, Arkansas, United States, 72703-4005
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Fayetteville, Arkansas, United States, 72703
United States, California
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Alhambra, California, United States, 91801
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Duarte, California, United States, 91010
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Fullerton, California, United States, 92835
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Los Angeles, California, United States, 90095
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Los Angeles, California, United States, 90095-1772
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Pasadena, California, United States, 91105
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Redondo Beach, California, United States, 90277
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Santa Maria, California, United States, 93454
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Santa Monica, California, United States, 90404
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South Pasadena, California, United States, 91030
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Valencia, California, United States, 91355
United States, Connecticut
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Norwalk, Connecticut, United States, 06856
United States, Florida
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Orlando, Florida, United States, 32803
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Orlando, Florida, United States, 32804
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Orlando, Florida, United States, 32804-4648
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Port St. Lucie, Florida, United States, 34952
United States, Georgia
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Atlanta, Georgia, United States, 30308
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Atlanta, Georgia, United States, 30322
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Atlanta, Georgia, United States, 30303
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Austell, Georgia, United States, 30106
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Carrollton, Georgia, United States, 30117
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Cartersville, Georgia, United States, 30121
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Columbus, Georgia, United States, 31904
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Decatur, Georgia, United States, 30033
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Douglasville, Georgia, United States, 30134
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Gainesville, Georgia, United States, 30501
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Lawrenceville, Georgia, United States, 30046
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Marietta, Georgia, United States, 30060
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Snellville, Georgia, United States, 30078
United States, Illinois
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Arlington Heights, Illinois, United States, 60005
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Arlington H€bhts, Illinois, United States, 60005
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Harvey, Illinois, United States, 60426
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Niles, Illinois, United States, 60714
United States, Indiana
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Evansville, Indiana, United States, 47713
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Newburgh, Indiana, United States, 47630
United States, Iowa
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Waterloo, Iowa, United States, 50701
United States, Kentucky
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Hazard, Kentucky, United States, 41701-9466
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Louisville, Kentucky, United States, 40207
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Louisville, Kentucky, United States, 40202
United States, Michigan
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Detroit, Michigan, United States, 48201
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Farmington Hills, Michigan, United States, 48334
United States, Mississippi
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Corinth, Mississippi, United States, 38834
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Starkville, Mississippi, United States, 39759
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Tupelo, Mississippi, United States, 38801
United States, Missouri
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Creve Coeur, Missouri, United States, 63141
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St. Louis, Missouri, United States, 63110
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St. Louis, Missouri, United States, 63110-1094
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St. Peters, Missouri, United States, 63376
United States, Nevada
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Las Vegas, Nevada, United States, 89135
United States, New Hampshire
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Lebanon, New Hampshire, United States, 03756
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Manchester, New Hampshire, United States, 03102
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Manchester, New Hampshire, United States, 3102
United States, New Jersey
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Denville, New Jersey, United States, 07834
United States, New York
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Stony Brook, New York, United States, 11794-8151
United States, North Carolina
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Hickory, North Carolina, United States, 28602
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Lenoir, North Carolina, United States, 28645
United States, Oklahoma
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Norman, Oklahoma, United States, 73071
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Oklahoma City, Oklahoma, United States, 73120-8347
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Oklahoma City, Oklahoma, United States, 73120
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Corvallis, Oregon, United States, 97330
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Sayre, Pennsylvania, United States, 18840
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Longview, Texas, United States, 75601
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Tyler, Texas, United States, 75702
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Waco, Texas, United States, 76712
United States, Washington
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Kennewick, Washington, United States, 99336
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Seattle, Washington, United States, 98109
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Seattle, Washington, United States, 98195
Austria
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Wien, Austria, 1140
Belgium
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Bruxelles, Belgium, 1000
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Charleroi, Belgium, 6000
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Mons, Belgium, 7000
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Roeselare, Belgium, 8800
China, Guangxi
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Nanning, Guangxi, China, 530021
China, Hubei
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Wuhan, Hubei, China, 430023
China, Jilin
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Changchun, Jilin, China, 130012
China, Sichuan
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Chengdu, Sichuan, China, 610041
China
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Changchun, China, 130012
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Guangxi, China, 530021
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Shanghai, China, 200433
Denmark
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Aaborg, Denmark, 9100
Finland
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Helsinki, Finland, 00290
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Pori, Finland, 28500
France
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Dijon, France, 21079
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Grenoble Cedex 09, France, 38043
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Paris, France, 75014
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Poitiers Cedex, France, 86021
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Saint-Herblain, France, 44805
Germany
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Aachen, Germany, 52074
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Gauting, Germany, 82131
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Immenhausen, Germany, 34376
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Mainz, Germany, 55131
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Moers, Germany, 47441
Greece
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Heraklion, Crete, Greece, 71110
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Athens, Greece, 11527
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Larissa, Greece, 41110
Hungary
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Budapest, Hungary, 1125
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Debrecen, Hungary, 4032
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Farkasgyepu, Hungary, 8582
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Gyula, Hungary, 5703
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Nyiregyhaza, Hungary, 4412
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Zalaegerszeg-Pozva, Hungary, 8900
India
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Navrangpura / Ahmedabad, Gujarat, India, 380 009
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Bangalore, Karnataka, India, 560 017
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Mumbai, Maharashtra, India, 400012
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Pune, Maharastra, India, 411001
Ireland
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Dublin, Ireland, 8
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Dublin, Ireland, 9
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Dublin, Ireland, 4
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Waterford, Ireland
Japan
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Nagoya, Aichi, Japan
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Kashiwa, Chiba, Japan
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Matsuyama, Ehime, Japan
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Asahikawa, Hokkaido, Japan
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Akashi, Hyogo, Japan
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Kanazawa city, Ishikawa, Japan
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Yokohama, Kanagawa, Japan
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Sendai, Miyagi, Japan
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Kurashiki, Okayama, Japan
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Okayama-city, Okayama, Japan
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Sakai-shi, Osaka-fu, Japan
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Osaka-city, Osaka, Japan
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Osakasayama-shi, Osaka, Japan
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Sunto-gun, Shizuoka, Japan
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Chuo-Ku, Tokyo, Japan
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Ube-shi, Yamaguchi, Japan
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Fukuoka, Japan
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Koto-ku, Tokyo, Japan
Korea, Republic of
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Seoul, Korea, Republic of, 135-710
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Seoul, Korea, Republic of, 110-744
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Seoul, Korea, Republic of, 138-736
Mexico
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Oaxaca, Mexico, 68000
Poland
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Otwock, Mazowieckie, Poland, 05-400
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Warsaw, Mazowieckie, Poland, 02-781
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Warsaw, Mazowieckie, Poland, 04-736
Russian Federation
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Pyatigorsk, Russian Federation, 357502
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Saint-Petersburg, Russian Federation, 198255
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Saint-Petersburg, Russian Federation, 194044
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Saint-Petersburg, Russian Federation, 197089
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Saint-Petersburg, Russian Federation, 197022
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Saint-Petersburg, Russian Federation, 197758
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Samara, Russian Federation, 443031
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Sochi, Russian Federation, 354057
Slovakia
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Bratislava, Slovakia, 826 06
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Nitra, Slovakia, 949 88
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Nove Zamky, Slovakia, 94034
South Africa
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Kraaifontein, Western Cape, South Africa, 7570
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Bloemfontein, South Africa, 9301
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Johannesburg, South Africa, 2193
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Port Elizabeth, South Africa, 6045
Spain
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Elche, Alicante, Spain, 03203
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Badalona, Barcelona, Spain, 08916
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Castellón, Castellon, Spain, 12002
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Barcelona, Spain, 08041
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Barcelona, Spain, 08025
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Castellon, Spain
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Madrid, Spain, 28050
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Madrid, Spain, 28041
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Sevilla, Spain, 41013
Sweden
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Karlstad, Sweden, 651 85
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Stockholm, Sweden, 171 76
Switzerland
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Aarau, Switzerland, 5001
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Bellinzona, Switzerland, 06500
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Geneve, Switzerland, 1211
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St. Gallen, Switzerland, 9007
United Kingdom
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Maidstone, Kent, United Kingdom, ME16 9QQ
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Edmonton, United Kingdom, N18 IQX
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Leicester, United Kingdom, LE1 5WW
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London, United Kingdom, NW1 2PQ
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London, United Kingdom, N18 1QX
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Manchester, United Kingdom, M20 4BX
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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

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01360554     History of Changes
Other Study ID Numbers: A7471009
Study First Received: April 12, 2011
Last Updated: July 9, 2014
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
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Erlotinib
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 01, 2014