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

April 24, 2017 updated by: Pfizer

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
878

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Vienna, Austria, 1140
        • Sozialmedizinisches Zentrum Baumgartner Hoehe - Otto Wagner Spital und Pflegezentrum
  • Belgium
      • Brussels, Belgium, 1000
        • Institut Jules Bordet
      • Brussels, Belgium, 1000
        • Laboratoire de la Porte de Hall
      • Charleroi, Belgium, 6000
        • Grand Hôpital de Charleroi Oncologie-Hématologie
      • Mons, Belgium, 7000
        • CHU Ambroise Parre- Service Biologie Clinique
      • Roeselare, Belgium, 8800
        • Heilig Hart Ziekenhuis Roeselare-Menen
  • China
      • Shanghai, China, 200433
        • Shanghai Pulmonary Hospital
    • Guangxi
      • Nanning, Guangxi, China, 530021
        • Tumour Hospital of Guangxi Zhuang Autonomous Region
    • Hubei
      • Wuhan, Hubei, China, 430023
        • Union Hospital, Tongji Medical College of Huazhong University of Science & Technology/Cancer Center
    • Jilin
      • Changchun, Jilin, China, 130012
        • Jilin Provincial Cancer Hospital
    • Sichuan
      • Chengdu, Sichuan, China, 610041
        • West China Hospital of Sichuan University
  • Denmark
      • Aalborg, Denmark, 9100
        • Aalborg Sygehus Syd
  • Finland
      • Helsinki, Finland, 00290
        • Helsingin yliopistollinen sairaala, Meilahden kolmiosairaala, keuhkosairauksien poliklinikka
      • Pori, Finland, 28500
        • Satakunnan keskussairaala/Keuhkosairauksien osasto A4
  • France
      • Dijon, France, 21079
        • Centre Georges François Leclerc
      • Grenoble cedex 09, France, 38043
        • Hôpital Albert Michallon
      • Paris, France, 75014
        • Hôpital Paris Saint Joseph
      • Poitiers Cedex, France, 86021
        • Chu de Poitiers
      • Saint Herblain cedex, France, 44805
        • Institut de Cancerologie de lOuest - Rene Gauducheau
  • Germany
      • Aachen, Germany, 52074
        • Universitaetsklinikum Aachen
      • Gauting, Germany, 82131
        • Asklepios Fachkliniken Muenchen-Gauting
      • Immenhausen, Germany, 34376
        • Lungenfachklinik Immenhausen
      • Mainz, Germany, 55131
        • Universitaetsmedizin der Johannes Gutenberg-Universitaet
      • Moers, Germany, 47441
        • Krankenhaus Bethanien, Medizinische Klinik III
  • Greece
      • Athens, Greece, 11527
        • Sotiria General Hospital of Athens
      • Heraklion, Greece, 71110
        • University Hospital of Heraklion
    • Thessaly
      • Larissa, Thessaly, Greece, 41110
        • University Hospital of Larissa
  • Hungary
      • Budapest, Hungary, 1125
        • Semmelweis Egyetem Pulmonologiai Klinika
      • Debrecen, Hungary, 4032
        • Debreceni Egyetem Orvos- es Egeszsegtudomanyi Centrum
      • Farkasgyepu, Hungary, 8582
        • Veszprem Megyei Onkormanyzat Tudogyogyintezete
      • Gyula, Hungary, 5703
        • Pandy Kalman Megyei Korhaz, Aktiv Tudogyogyaszat
      • Nyiregyhaza, Hungary, 4412
        • Jósa András Oktatókórház Egészségügyi Szolgáltató Nonprofit Kft.
      • Zalaegerszeg-Pozva, Hungary, 8900
        • Zala Megyei Korhaz, Pulmonologiai Osztaly
  • India
    • Gujarat
      • Ahmedabad, Gujarat, India, 380 009
        • Vedanta Institute Of Medical Sciences
    • Karnataka
      • Bangalore, Karnataka, India, 560017
        • Manipal Hospital
    • Maharashtra
      • Mumbai, Maharashtra, India, 400012
        • Tata Memorial Centre
    • Maharastra
      • Pune, Maharastra, India, 411001
        • Ruby Hall Clinic
  • Ireland
      • Dublin, Ireland, 8
        • St. James Hospital
      • Waterford, Ireland
        • Oncology Department
    • Leinster
      • Dublin, Leinster, Ireland, Dublin 4
        • St Vincent's University Hospital
      • Dublin, Leinster, Ireland, Dublin 9
        • Beaumont Hospital
  • Japan
      • Fukuoka, Japan, 810-8563
        • National Hp. Org. Kyushu Medical Center
      • Fukuoka, Japan, 811-1395
        • National Hospital Organization Kyushu Cancer Center/Department of Thoracic Oncology
      • Fukuoka, Japan, 812-8582
        • Kyushu University Hospital Respiratory Medicine
      • Koto-ku, Tokyo, Japan, 135-8550
        • The Cancer Institute Hospital Of JFCR
    • Aichi
      • Nagoya, Aichi, Japan, 464-8681
        • Aichi cancer center central hospital /Thoracic Oncology
    • Chiba
      • Kashiwa, Chiba, Japan, 277-8577
        • National Cancer Center Hospital East
    • Ehime
      • Matsuyama-city, Ehime, Japan, 791-0280
        • National Hospital Organization Shikoku Cancer Center
    • Hokkaido
      • Asahikawa, Hokkaido, Japan, 070-8644
        • National Hospital Organization Asahikawa Medical Center
    • Hyogo
      • Akashi, Hyogo, Japan, 673-8558
        • Hyogo Cancer Center
    • Ishikawa
      • Kanazawa city, Ishikawa, Japan, 9208641
        • Kanazawa University Hospital
    • Kanagawa
      • Yokohama, Kanagawa, Japan, 236-0051
        • Kanagawa Cardiovascular and Respiratory Center
    • Miyagi
      • Sendai, Miyagi, Japan, 980-8574
        • Tohoku University Hospital
    • Okayama
      • Kurashiki, Okayama, Japan, 710-8602
        • Kurashiki Central Hospital
      • Okayama-city, Okayama, Japan, 700-8558
        • Okayama University Hospital
    • Osaka
      • Osaka-city, Osaka, Japan, 534-0021
        • Osaka City General Hospital Department of Clinical Oncology
      • Osakasayama-shi, Osaka, Japan, 589-8511
        • Kinki University Hospital
    • Osaka-fu
      • Sakai-Shi, Osaka-fu, Japan, 591-8555
        • National Hospital Organization Kinki-Chuo Chest Medical Center
    • Shizuoka
      • Sunto-gun, Shizuoka, Japan, 411-8777
        • Shizuoka Cancer Center
    • Tokyo
      • Chuo-Ku, Tokyo, Japan, 104-0045
        • National Cancer Center Hospital
    • Yamaguchi
      • Ube-shi, Yamaguchi, Japan, 755-0241
        • National Hospital Organization, Yamaguchi-Ube Medical Center
  • Korea, Republic of
      • Seoul, Korea, Republic of, 110-744
        • Seoul National University Hospital
      • Seoul, Korea, Republic of, 135-710
        • Samsung Medical Center, Clinical Trial Center
      • Seoul, Korea, Republic of, 138-736
        • Asan Medical Center, Department of Oncology
  • Mexico
      • Oaxaca, Mexico, 68000
        • Oaxaca Site Management Organization
  • Poland
    • Mazowieckie
      • Otwock, Mazowieckie, Poland, 05-400
        • Mazowieckie Centrum Leczenia Chorob Pluc I Gruzlicy
      • Otwock, Mazowieckie, Poland, 05-400
        • Zoz All-Medi
      • Warsaw, Mazowieckie, Poland, 02-781
        • Centrum Onkologii-Instytut im. Marii Sklodowskiej-Curie
      • Warsaw, Mazowieckie, Poland, 04-736
        • Nukleomed
  • Russian Federation
      • Pyatigorsk, Russian Federation, 357502
        • Pyatigorsk Oncology Center
      • Saint-Petersburg, Russian Federation, 197022
        • City Clinical Oncology Dispensary
      • Saint-Petersburg, Russian Federation, 198255
        • City Clinical Oncology Dispensary
      • Saint-Petersburg, Russian Federation, 194044
        • Clinic of Hospital Surgery
      • Saint-Petersburg, Russian Federation, 194044
        • Military Medical Academy n.a. S.M.Kirov
      • Saint-Petersburg, Russian Federation, 197022
        • St.-Petersburg State Medical University I.P.Pavlov of Roszdrav
      • Saint-Petersburg, Russian Federation, 197089
        • Research Institute of Pulmonology
      • Saint-Petersburg, Russian Federation, 197758
        • Russian Scientific Center of Radiology and Surgical Technologies
      • Samara, Russian Federation, 443031
        • Samara Regional Clinical Oncology Dispensary
    • Krasnodarskij Kraj
      • Krasnodar, Krasnodarskij Kraj, Russian Federation, 350012
        • City Hospital #2 Krasnodar Multi-Field Diagnostic and Treatment Association
      • Sochi, Krasnodarskij Kraj, Russian Federation, 354057
        • Oncology Center # 2
    • Stavropolskij Kraj
      • Pyatigorsk, Stavropolskij Kraj, Russian Federation, 357340
        • Federal State Healthcare Clinical Hospital #101 of the Federal Biomedical Agency
  • Slovakia
      • Bratislava, Slovakia, 826 06
        • Univerzitna Nemocnica Bratislava, Klinika pneumologie a ftizeologie I- Oddelenie klinickej onkologie
      • Nitra, Slovakia, 949 88
        • Specializovana nemocnica sv. Svorada Zobor, n.o.
      • Nove Zamky, Slovakia, 94034
        • Fakultna nemocnica s poliklinikou
  • South Africa
      • Bloemfontein, South Africa, 9301
        • Department of Oncotherapy
      • Port Elizabeth, South Africa, 6045
        • GVI Oncology
    • Gauteng
      • Parktown,Johannesburg, Gauteng, South Africa, 2193
        • WCR: Wits Clinical Research
    • Western Cape
      • Kraaifontein, Western Cape, South Africa, 7570
        • GVI Oncology Clinical Research Unit
  • Spain
      • Barcelona, Spain, 08041
        • Hospital De La Santa Creu I Sant Pau
      • Barcelona, Spain, 08025
        • HOSPITAL DE LA SANTA CREU I SANT PAU - Pharmacy
      • 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 - Hospital de Día
      • Castellon, Spain
        • Hospital Provincial de Castellon (Farmacia)
      • Madrid, Spain, 28050
        • Hospital Universitario Madrid Sanchinarro
      • Madrid, Spain, 28041
        • Hospital Universitario 12 de Octubre-Radiology
      • Madrid, Spain, 28041
        • Hospital Universitario 12 de Octubre01
      • Sevilla, Spain, 41013
        • Hospital Universitario Virgen del Rocio. Hospital General Planta Baja. Servicio de Oncologia.
    • Alicante
      • Elche, Alicante, Spain, 03203
        • Hospital General Universitario de Elche - Edificio UIAE
    • Barcelona
      • Badalona, Barcelona, Spain, 08916
        • Hospital Universitari Germans Trias i Pujol
    • Castellon
      • Castellón, Castellon, Spain, 12002
        • Hospital Provincial de Castellon - Servicio de Oncologia
  • Sweden
      • Karlstad, Sweden, 651 85
        • KPE/Onkologikliniken
      • Stockholm, Sweden, 171 76
        • Karolinska Universitetssjukhuset
  • Switzerland
      • Aarau, Switzerland, 5001
        • Kantonsspital Aarau
      • Bellinzona, Switzerland, 06500
        • Istituto Oncologico della Svizzera Italiana
      • Geneve 14, Switzerland, 1211
        • Hôpitaux Universitaires de Genève
      • Locarno, Switzerland, 06600
        • Ospedale Regionale di Locarno La Carità
      • St. Gallen, Switzerland, 9007
        • Kantonsspital St. Gallen
  • United Kingdom
      • Edmonton, United Kingdom, N18 1QX
        • North Middlesex NHS Trust
      • Leicester, United Kingdom, LE1 5WW
        • Leicester Royal Infirmary
      • London, United Kingdom, NW1 2PQ
        • Cancer Clinical Trials Unit
      • Manchester, United Kingdom, M20 4BX
        • 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
    • Kent
      • Maidstone, Kent, United Kingdom, ME16 9QQ
        • Kent Oncology Centre
    • West Midlands
      • Wolverhampton, West Midlands, United Kingdom, WV10 0QP
        • New Cross Hospital - Royal Wolverhampton Hospital NHS Trust
  • United States
    • Alabama
      • 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
        • University of Alabama at Birmingham
      • Florence, Alabama, United States, 35630
        • Northwest Alabama Cancer Center
      • Mobile, Alabama, United States, 36604
        • University of South Alabama Mitchell Cancer Institute
      • Mobile, Alabama, United States, 36617
        • University of South Alabama Medical Center
      • Muscle Shoals, Alabama, United States, 35661
        • Northwest Alabama Cancer Center
    • Arizona
      • Chandler, Arizona, United States, 85224
        • Ironwood physicians P C dba Ironwood Cancer & Research Centers
      • Chandler, Arizona, United States, 85224
        • Ironwood Physicians P.C. dba Ironwood Cancer and Research Centers
      • Gilbert, Arizona, United States, 85297
        • Ironwood Physicians P.C. dba Ironwood Cancer and Research Centers
      • Mesa, Arizona, United States, 85202
        • Desert Oncology Associates dba Ironwood Cancer and Research Centers
      • Mesa, Arizona, United States, 85206
        • Ironwood Physicians P.C. dba Ironwood Cancer and Research Centers
    • Arkansas
      • Fayetteville, Arkansas, United States, 72703
        • Highlands Oncology Group PA
      • Rogers, Arkansas, United States, 72758
        • Highlands Oncology Group, PA
    • California
      • Alhambra, California, United States, 91801
        • Central Hematology Oncology Medical Group Inc.
      • Alhambra, California, United States, 91801
        • UCLA Hematology Oncology-Alhambra
      • Duarte, California, United States, 91010
        • City of Hope
      • Fullerton, California, United States, 92835
        • St. Jude Heritage Healthcare
      • Los Angeles, California, United States, 90095
        • Ronald Reagan UCLA Medical Center
      • Los Angeles, California, United States, 90095-1772
        • UCLA West Medical Pharmacy
      • Los Angeles, California, United States, 90095
        • Westwood Bowyer Clinic, Peter Morton Medical Building
      • Los Angeles, California, United States, 90095
        • TORI Central Administration
      • Los Angeles, California, United States, 90095-1772
        • Drug Management Only
      • Los Angeles, California, United States, 90095-1772
        • Drug Managerrent Only:
      • Los Angeles, California, United States, 90095
        • 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:
      • Pasadena, California, United States, 91105
        • UCLA/Pasadena Healthcare Hematology-Oncology
      • Pasadena, California, United States, 91107
        • Central Hematology Oncology Medical Group, Inc.
      • Redondo Beach, California, United States, 90277
        • Cancer Care Associates Medical Group Inc.
      • Santa Maria, California, United States, 93454
        • Central Coast Medical Oncology Corporation
      • Santa Monica, California, United States, 90404
        • UCLA Hematology Oncology-Santa Monica
      • Santa Monica, California, United States, 90404
        • UCLA Hematology Oncology-Parkside
      • Santa Monica, California, United States, 90404
        • UCLA Santa Monica Medical Center & Orthopedic Hospital
      • South Pasadena, California, United States, 91030
        • City of Hope South Pasadena Cancer Center
      • Valencia, California, United States, 91355
        • UCLA/Santa Clarita Valley Cancer Center
      • Westlake Village, California, United States, 91361
        • UCLA Cancer Center
    • Connecticut
      • Norwalk, Connecticut, United States, 06856
        • Norwalk Hospital
    • Florida
      • Orlando, Florida, United States, 32803
        • Florida Hospital
      • Orlando, Florida, United States, 32804
        • Hematology and Oncology Consultants, P.A.
      • Orlando, Florida, United States, 32804
        • Cancer Institute Of Florida
      • Orlando, Florida, United States, 32804
        • Investigational Drug Services, Florida Hospital
      • Port Saint Lucie, Florida, United States, 34952
        • Hematology Oncology Associates of the Treasure Coast
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Emory University Hospital
      • Atlanta, Georgia, United States, 30308
        • Emory University Hospital Midtown
      • Atlanta, Georgia, United States, 30322
        • Winship Cancer Institute of Emory University
      • Atlanta, Georgia, United States, 30322
        • Emory Clinic
      • Austell, Georgia, United States, 30106
        • Northwest Georgia Oncology Centers, P.C.
      • Carrollton, Georgia, United States, 30117
        • Northwest Georgia Oncology Centers, P.C.
      • Cartersville, Georgia, United States, 30121
        • Northwest Georgia Oncology Centers, PC
      • Columbus, Georgia, United States, 31904
        • John B. Amos Cancer Center
      • Decatur, Georgia, United States, 30033
        • Georgia Cancer Specialists
      • Decatur, Georgia, United States, 30033
        • The Cancer Center at DeKalb Medical
      • Decatur, Georgia, United States, 30033
        • Atlanta Cancer Care
      • Douglasville, Georgia, United States, 30134
        • Northwest Georgia Oncology Centers, P.C.
      • Duluth, Georgia, United States, 30096
        • Suburban Hematology-Oncology Associates, P.C.
      • Gainesville, Georgia, United States, 30501
        • 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
      • Lawrenceville, Georgia, United States, 30046
        • Suburban Hematology-Oncology Associates, P.C.
      • Marietta, Georgia, United States, 30060
        • Northwest Georgia Oncology Centers, P.C.
      • Snellville, Georgia, United States, 30078
        • Suburban Hematology-Oncology Associates, P.C.
    • Illinois
      • Arlington Heights, Illinois, United States, 60005
        • Illinois Cancer Specialists
      • Harvey, Illinois, United States, 60426
        • Ingalls Memorial Hospital
      • Harvey, Illinois, United States, 60426
        • Monroe Medical Associates
      • Harvey, Illinois, United States, 60426
        • Ingalls Memorial Hospital - In-Patient Pharmacy
      • Niles, Illinois, United States, 60714
        • Illinois Cancer Specialists
      • Tinley Park, Illinois, United States, 60477
        • Monroe Medical Associates
    • Indiana
      • Evansville, Indiana, United States, 47713
        • Deaconess Clinic Downtown
      • Munster, Indiana, United States, 46321
        • Monroe Medical Associates
    • Iowa
      • Waterloo, Iowa, United States, 50701
        • Cedar Valley Medical Specialists, P.C.
    • Kentucky
      • Hazard, Kentucky, United States, 41701-9466
        • Kentucky Cancer Clinic
      • Louisville, Kentucky, United States, 40207
        • Baptist Hospital East
      • Louisville, Kentucky, United States, 40202
        • University Medical Center, Inc
      • Louisville, Kentucky, United States, 40202
        • University Medical Center, Inc.
    • Michigan
      • Detroit, Michigan, United States, 48201
        • Karmanos Cancer Institute
      • Farmington Hills, Michigan, United States, 48334
        • Karmanos Cancer Institute at Farmington Hills
    • Mississippi
      • Starkville, Mississippi, United States, 39759
        • North Mississippi Hematology and Oncology Associates, Ltd.
      • Tupelo, Mississippi, United States, 38801
        • North Mississippi Hematology and Oncology Associates, Ltd.,
    • Missouri
      • Creve Coeur, Missouri, United States, 63141
        • Siteman Cancer Center-West County
      • Saint Louis, Missouri, United States, 63110-1094
        • Barnes Jewish Hospital
      • Saint Louis, Missouri, United States, 63110
        • Washington University School of Medicine-IDS Pharmacy
      • Saint Peters, Missouri, United States, 63376-1645
        • Siteman Cancer Center-St. Peters
    • New Hampshire
      • Lebanon, New Hampshire, United States, 03756
        • Dartmouth-Hitchcock Medical Center /Mary Hitchcock Memorial Hospital
    • New Jersey
      • Denville, New Jersey, United States, 07834
        • Oncology and Hematology Specialists, P.A.
    • New York
      • Stony Brook, New York, United States, 11794-9447
        • Stony Brook University-Cancer Center
    • North Carolina
      • Hickory, North Carolina, United States, 28602
        • Carolina Oncology Specialists PA
      • Lenoir, North Carolina, United States, 28645
        • Carolina Oncology Specialists PA
    • Oklahoma
      • Norman, Oklahoma, United States, 73071
        • Mercy clinic oklahoma communities, Inc. - Mercy clinic oncology/Hematology - Norman
      • Oklahoma City, Oklahoma, United States, 73120-8347
        • Mercy Physicians of Oklahoma-Communities, Inc. - Mercy Clinic Oncology/Hematology - McAuley
      • Oklahoma City, Oklahoma, United States, 73120
        • Mercy Hospital Oklahoma City - Oncology Infusion
    • Oregon
      • Corvallis, Oregon, United States, 97330
        • Samaritan Hematology & Oncology Consultants
      • Corvallis, Oregon, United States, 97330
        • Good Samaritan Hospital Samaritan Ambulatory Infusion Services
      • Corvallis, Oregon, United States, 97330
        • Samaritan Pharmacy Services
      • Lincoln City, Oregon, United States, 97367
        • Samaritan North Lincoln Hospital
      • Newport, Oregon, United States, 97365
        • Samaritan Pacific Communities Hospital
    • Pennsylvania
      • Sayre, Pennsylvania, United States, 18840
        • Guthrie Clinic, Limited
      • Sayre, Pennsylvania, United States, 18840
        • Robert Packer Hospital
    • Texas
      • Longview, Texas, United States, 75601
        • Texas Oncology-Longview Cancer Center
      • Tyler, Texas, United States, 75702
        • Texas Oncology-Tyler
      • Waco, Texas, United States, 76712
        • Texas Oncology - Waco
    • Washington
      • Kennewick, Washington, United States, 99336
        • Kadlec Clinic Hematology and Oncology
      • Richland, Washington, United States, 99352
        • Kadlec Medical Center
      • Richland, Washington, United States, 99352
        • Outpatient Imaging Center
      • Seattle, Washington, United States, 98109
        • Seattle Cancer Care Alliance
      • Seattle, Washington, United States, 98195
        • University of Washington Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
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.
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.
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.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
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 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.
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.
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).
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 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.
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.
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.
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.
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.
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.
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.
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 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.
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.
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.
Baseline up to Cycle 5 Day 1
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.
Baseline up to Cycle 5 Day 1
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.
Data taken from Cycle 1 day 1 to the end of treatment or withdrawal.
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.
Data taken from Cycle 1 day 1 to the end of treatment or withdrawal, averaged (mean) to provide overall scores.
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.
Data taken from Cycle 1 day 1 to the end of treatment or withdrawal, averaged (mean) to provide overall scores.
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.
Data taken from Cycle 1 day 1 to the end of treatment or withdrawal, averaged (mean) to provide overall scores.
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).
Data taken from Cycle 1 day 1 to the end of treatment or withdrawal, averaged (mean) to provide overall scores.

Collaborators and Investigators

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Sponsor

Sponsor

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Pfizer

Publications and helpful links

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General Publications

Helpful Links

Study record dates

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Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 16, 2011

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 30, 2013

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 14, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 12, 2011

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 24, 2011

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 25, 2011

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 24, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 24, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2017

More Information

Terms related to this study

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Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • A7471009
  • 2010-022656-22 (EUDRACT_NUMBER)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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