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Non-Small Cell Lung CancerPhase 3ARCHER 1009NCT01360554

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

A Phase 3 study testing Dacomitinib (PF-00299804) and Active Comparator (erlotinib) in people with Non-Small Cell Lung Cancer, run by Pfizer at 224 sites in 23 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

This is a multinational, multicenter, randomized,double-blinded, Phase 3 study comparing the efficacy and safety of treatment with PF-00299804 to treatment with erlotinib in patients with advanced non-small cell lung cancer, previously treated with at least one prior regimen. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Non-Small Cell Lung Cancer
What is being tested?
Dacomitinib (PF-00299804) and Active Comparator (erlotinib)
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
878 participants
Where
224 sitesin 23 countries
Study dates
16 Jun 2011to 14 Sep 2015
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

224 sites in 23 countries.

224 sites in 23 countries

United States107 sites

  • Central Hematology Oncology Medical Group Inc.

    Alhambra, California, 91801

  • UCLA Hematology Oncology-Alhambra

    Alhambra, California, 91801

  • Illinois Cancer Specialists

    Arlington Heights, Illinois, 60005

  • Emory University Hospital Midtown

    Atlanta, Georgia, 30308

  • Emory Clinic

    Atlanta, Georgia, 30322

  • Emory University Hospital

    Atlanta, Georgia, 30322

  • Winship Cancer Institute of Emory University

    Atlanta, Georgia, 30322

  • Northwest Georgia Oncology Centers, P.C.

    Austell, Georgia, 30106

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35233

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35249

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35294

  • Northwest Georgia Oncology Centers, P.C.

    Carrollton, Georgia, 30117

  • Northwest Georgia Oncology Centers, PC

    Cartersville, Georgia, 30121

  • Ironwood physicians P C dba Ironwood Cancer & Research Centers

    Chandler, Arizona, 85224

  • Ironwood Physicians P.C. dba Ironwood Cancer and Research Centers

    Chandler, Arizona, 85224

  • Siteman Cancer Center-St. Peters

    City of Saint Peters, Missouri, 63376-1645

  • John B. Amos Cancer Center

    Columbus, Georgia, 31904

  • Good Samaritan Hospital Samaritan Ambulatory Infusion Services

    Corvallis, Oregon, 97330

  • Samaritan Hematology & Oncology Consultants

    Corvallis, Oregon, 97330

  • Samaritan Pharmacy Services

    Corvallis, Oregon, 97330

  • Siteman Cancer Center-West County

    Creve Coeur, Missouri, 63141

  • Atlanta Cancer Care

    Decatur, Georgia, 30033

  • Georgia Cancer Specialists

    Decatur, Georgia, 30033

  • The Cancer Center at DeKalb Medical

    Decatur, Georgia, 30033

  • Oncology and Hematology Specialists, P.A.

    Denville, New Jersey, 07834

  • Karmanos Cancer Institute

    Detroit, Michigan, 48201

  • Northwest Georgia Oncology Centers, P.C.

    Douglasville, Georgia, 30134

  • City of Hope

    Duarte, California, 91010

  • Suburban Hematology-Oncology Associates, P.C.

    Duluth, Georgia, 30096

  • Deaconess Clinic Downtown

    Evansville, Indiana, 47713

  • Karmanos Cancer Institute at Farmington Hills

    Farmington Hills, Michigan, 48334

  • Highlands Oncology Group PA

    Fayetteville, Arkansas, 72703

  • Northwest Alabama Cancer Center

    Florence, Alabama, 35630

  • St. Jude Heritage Healthcare

    Fullerton, California, 92835

  • Northeast Georgia Medical Center

    Gainesville, Georgia, 30501

  • Oncology Specialists of North Georgia, LLC

    Gainesville, Georgia, 30501

  • The Longstreet Clinic Cancer Center

    Gainesville, Georgia, 30501

  • Ironwood Physicians P.C. dba Ironwood Cancer and Research Centers

    Gilbert, Arizona, 85297

  • Ingalls Memorial Hospital - In-Patient Pharmacy

    Harvey, Illinois, 60426

  • Ingalls Memorial Hospital

    Harvey, Illinois, 60426

  • Monroe Medical Associates

    Harvey, Illinois, 60426

  • Kentucky Cancer Clinic

    Hazard, Kentucky, 41701-9466

  • Carolina Oncology Specialists PA

    Hickory, North Carolina, 28602

  • Kadlec Clinic Hematology and Oncology

    Kennewick, Washington, 99336

  • Suburban Hematology-Oncology Associates, P.C.

    Lawrenceville, Georgia, 30046

  • Dartmouth-Hitchcock Medical Center /Mary Hitchcock Memorial Hospital

    Lebanon, New Hampshire, 03756

  • Carolina Oncology Specialists PA

    Lenoir, North Carolina, 28645

  • Samaritan North Lincoln Hospital

    Lincoln City, Oregon, 97367

  • Texas Oncology-Longview Cancer Center

    Longview, Texas, 75601

  • Drug Management Only

    Los Angeles, California, 90095-1772

  • Drug Managerrent Only:

    Los Angeles, California, 90095-1772

  • UCLA West Medical Pharmacy

    Los Angeles, California, 90095-1772

  • Administrative Address: UCLA Hematology Oncology-Clinical Research Unit (CRU)

    Los Angeles, California, 90095

  • Drug Shipment Address: Ronald Reagan UCLA Medical Center, Drug Information Center

    Los Angeles, California, 90095

  • Regulatory Management Only:

    Los Angeles, California, 90095

  • Regulatory Management:

    Los Angeles, California, 90095

  • Ronald Reagan UCLA Medical Center

    Los Angeles, California, 90095

  • TORI Central Administration

    Los Angeles, California, 90095

  • Westwood Bowyer Clinic, Peter Morton Medical Building

    Los Angeles, California, 90095

  • University Medical Center, Inc.

    Louisville, Kentucky, 40202

  • University Medical Center, Inc

    Louisville, Kentucky, 40202

  • Baptist Hospital East

    Louisville, Kentucky, 40207

  • Northwest Georgia Oncology Centers, P.C.

    Marietta, Georgia, 30060

  • Desert Oncology Associates dba Ironwood Cancer and Research Centers

    Mesa, Arizona, 85202

  • Ironwood Physicians P.C. dba Ironwood Cancer and Research Centers

    Mesa, Arizona, 85206

  • University of South Alabama Mitchell Cancer Institute

    Mobile, Alabama, 36604

  • University of South Alabama Medical Center

    Mobile, Alabama, 36617

  • Monroe Medical Associates

    Munster, Indiana, 46321

  • Northwest Alabama Cancer Center

    Muscle Shoals, Alabama, 35661

  • Samaritan Pacific Communities Hospital

    Newport, Oregon, 97365

  • Illinois Cancer Specialists

    Niles, Illinois, 60714

  • Mercy clinic oklahoma communities, Inc. - Mercy clinic oncology/Hematology - Norman

    Norman, Oklahoma, 73071

  • Norwalk Hospital

    Norwalk, Connecticut, 06856

  • Mercy Physicians of Oklahoma-Communities, Inc. - Mercy Clinic Oncology/Hematology - McAuley

    Oklahoma City, Oklahoma, 73120-8347

  • Mercy Hospital Oklahoma City - Oncology Infusion

    Oklahoma City, Oklahoma, 73120

  • Florida Hospital

    Orlando, Florida, 32803

  • Cancer Institute of Florida

    Orlando, Florida, 32804

  • Hematology and Oncology Consultants, P.A.

    Orlando, Florida, 32804

  • Investigational Drug Services, Florida Hospital

    Orlando, Florida, 32804

  • UCLA/Pasadena Healthcare Hematology-Oncology

    Pasadena, California, 91105

  • Central Hematology Oncology Medical Group, Inc.

    Pasadena, California, 91107

  • Hematology Oncology Associates of the Treasure Coast

    Port Saint Lucie, Florida, 34952

  • Cancer Care Associates Medical Group Inc.

    Redondo Beach, California, 90277

  • Kadlec Medical Center

    Richland, Washington, 99352

  • Outpatient Imaging Center

    Richland, Washington, 99352

  • Highlands Oncology Group, PA

    Rogers, Arkansas, 72758

  • Central Coast Medical Oncology Corporation

    Santa Maria, California, 93454

  • UCLA Hematology Oncology-Parkside

    Santa Monica, California, 90404

  • UCLA Hematology Oncology-Santa Monica

    Santa Monica, California, 90404

  • UCLA Santa Monica Medical Center & Orthopedic Hospital

    Santa Monica, California, 90404

  • Guthrie Clinic, Limited

    Sayre, Pennsylvania, 18840

  • Robert Packer Hospital

    Sayre, Pennsylvania, 18840

  • Seattle Cancer Care Alliance

    Seattle, Washington, 98109

  • University of Washington Medical Center

    Seattle, Washington, 98195

  • Suburban Hematology-Oncology Associates, P.C.

    Snellville, Georgia, 30078

  • City of Hope South Pasadena Cancer Center

    South Pasadena, California, 91030

  • Barnes Jewish Hospital

    St Louis, Missouri, 63110-1094

  • Washington University School of Medicine-IDS Pharmacy

    St Louis, Missouri, 63110

  • North Mississippi Hematology and Oncology Associates, Ltd.

    Starkville, Mississippi, 39759

  • Stony Brook University-Cancer Center

    Stony Brook, New York, 11794-9447

  • Monroe Medical Associates

    Tinley Park, Illinois, 60477

  • North Mississippi Hematology and Oncology Associates, Ltd.,

    Tupelo, Mississippi, 38801

  • Texas Oncology-Tyler

    Tyler, Texas, 75702

  • UCLA/Santa Clarita Valley Cancer Center

    Valencia, California, 91355

  • Texas Oncology - Waco

    Waco, Texas, 76712

  • Cedar Valley Medical Specialists, P.C.

    Waterloo, Iowa, 50701

  • UCLA Cancer Center

    Westlake Village, California, 91361

Other trials in United States

Japan20 sites

  • Hyogo Cancer Center

    Akashi, Hyōgo, 673-8558

  • National Hospital Organization Asahikawa Medical Center

    Asahikawa, Hokkaido, 070-8644

  • National Cancer Center Hospital

    Chuo-Ku, Tokyo, 104-0045

  • National Hp. Org. Kyushu Medical Center

    Fukuoka, 810-8563

  • National Hospital Organization Kyushu Cancer Center/Department of Thoracic Oncology

    Fukuoka, 811-1395

  • Kyushu University Hospital Respiratory Medicine

    Fukuoka, 812-8582

  • Kanazawa University Hospital

    Kanazawa, Ishikawa-ken, 9208641

  • National Cancer Center Hospital East

    Kashiwa, Chiba, 277-8577

  • The Cancer Institute Hospital of JFCR

    Koto-ku, Tokyo, 135-8550

  • Kurashiki Central Hospital

    Kurashiki, Okayama-ken, 710-8602

  • National Hospital Organization Shikoku Cancer Center

    Matsuyama, Ehime, 791-0280

  • Aichi cancer center central hospital /Thoracic Oncology

    Nagoya, Aichi-ken, 464-8681

  • Okayama University Hospital

    Okayama, Okayama-ken, 700-8558

  • Osaka City General Hospital Department of Clinical Oncology

    Osaka, Osaka, 534-0021

  • Kinki University Hospital

    Osakasayama-shi, Osaka, 589-8511

  • National Hospital Organization Kinki-chuo Chest Medical Center

    Sakai-Shi, Osaka, 591-8555

  • Tohoku University Hospital

    Sendai, Miyagi, 980-8574

  • Shizuoka Cancer Center

    Sunto-gun, Shizuoka, 411-8777

  • National Hospital Organization, Yamaguchi-Ube Medical Center

    Ube-shi, Yamaguchi, 755-0241

  • Kanagawa Cardiovascular and Respiratory Center

    Yokohama, Kanagawa, 236-0051

Other trials in Japan

Spain14 sites

  • Hospital Universitari Germans Trias i Pujol

    Badalona, Barcelona, 08916

  • HOSPITAL DE LA SANTA CREU I SANT PAU - Pharmacy

    Barcelona, 08025

  • Hospital de la Santa Creu i Sant Pau - AGDAC

    Barcelona, 08041

  • Hospital de la Santa Creu i Sant Pau - Anatomia Patológica

    Barcelona, 08041

  • Hospital de la Santa Creu i Sant Pau - Diagnostic per la Imatge i Med. Nuclear

    Barcelona, 08041

  • Hospital de la Santa Creu i Sant Pau - Hospital de Día

    Barcelona, 08041

  • Hospital de la Santa Creu i Sant Pau

    Barcelona, 08041

  • Hospital Provincial de Castellon - Servicio de Oncologia

    Castellon, Castellon, 12002

  • Hospital Provincial de Castellon (Farmacia)

    Castellon

  • Hospital General Universitario de Elche - Edificio UIAE

    Elche, Alicante, 03203

  • Hospital Universitario 12 de Octubre-Radiology

    Madrid, 28041

  • Hospital Universitario 12 de Octubre01

    Madrid, 28041

  • Hospital Universitario Madrid Sanchinarro

    Madrid, 28050

  • Hospital Universitario Virgen del Rocio. Hospital General Planta Baja. Servicio de Oncologia.

    Seville, 41013

Other trials in Spain

Russia12 sites

  • City Hospital #2 Krasnodar Multi-Field Diagnostic and Treatment Association

    Krasnodar, Krasnodarskiy Kray, 350012

  • Federal State Healthcare Clinical Hospital #101 of the Federal Biomedical Agency

    Pyatigorsk, Stavropolskij Kraj, 357340

  • Pyatigorsk Oncology Center

    Pyatigorsk, 357502

  • Clinic of Hospital Surgery

    Saint Petersburg, 194044

  • Military Medical Academy n.a. S.M.Kirov

    Saint Petersburg, 194044

  • City Clinical Oncology Dispensary

    Saint Petersburg, 197022

  • St.-Petersburg State Medical University I.P.Pavlov of Roszdrav

    Saint Petersburg, 197022

  • Research Institute of Pulmonology

    Saint Petersburg, 197089

  • Russian Scientific Center of Radiology and Surgical Technologies

    Saint Petersburg, 197758

  • City Clinical Oncology Dispensary

    Saint Petersburg, 198255

  • Samara Regional Clinical Oncology Dispensary

    Samara, 443031

  • Oncology Center # 2

    Sochi, Krasnodarskiy Kray, 354057

Other trials in Russia

United Kingdom8 sites

  • North Middlesex NHS Trust

    Edmonton, N18 1QX

  • Leicester Royal Infirmary

    Leicester, LE1 5WW

  • Cancer Clinical Trials Unit

    London, NW1 2PQ

  • Kent Oncology Centre

    Maidstone, Kent, ME16 9QQ

  • Christie Hospital NHS Trust, Department of Medical Oncology

    Manchester, M20 4BX

  • Christie Hospital NHS Trust

    Manchester, M20 4BX

  • Lung and Melanoma Research Team

    Manchester, M20 4BX

  • New Cross Hospital - Royal Wolverhampton Hospital NHS Trust

    Wolverhampton, West Midlands, WV10 0QP

Other trials in United Kingdom

Hungary6 sites

  • Semmelweis Egyetem Pulmonologiai Klinika

    Budapest, 1125

  • Debreceni Egyetem Orvos- es Egeszsegtudomanyi Centrum

    Debrecen, 4032

  • Veszprem Megyei Onkormanyzat Tudogyogyintezete

    Farkasgyepű, 8582

  • Pandy Kalman Megyei Korhaz, Aktiv Tudogyogyaszat

    Gyula, 5703

  • Josa Andras Oktatokorhaz Egeszsegugyi Szolgaltato Nonprofit Kft.

    Nyíregyháza, 4412

  • Zala Megyei Korhaz, Pulmonologiai Osztaly

    Zalaegerszeg-Pozva, 8900

Other trials in Hungary

Belgium5 sites

  • Institut Jules Bordet

    Brussels, 1000

  • Laboratoire de la Porte de Hall

    Brussels, 1000

  • Grand Hopital de Charleroi Oncologie-Hematologie

    Charleroi, 6000

  • CHU Ambroise Parre- Service Biologie Clinique

    Mons, 7000

  • Heilig Hart Ziekenhuis Roeselare-Menen

    Roeselare, 8800

Other trials in Belgium

China5 sites

  • Jilin Provincial Cancer Hospital

    Changchun, Jilin, 130012

  • West China Hospital of Sichuan University

    Chengdu, Sichuan, 610041

  • Tumour Hospital of Guangxi Zhuang Autonomous Region

    Nanning, Guangxi, 530021

  • Shanghai Pulmonary Hospital

    Shanghai, 200433

  • Union Hospital, Tongji Medical College of Huazhong University of Science & Technology/Cancer Center

    Wuhan, Hubei, 430023

Other trials in China

France5 sites

  • Centre Georges Francois Leclerc

    Dijon, 21079

  • Hopital Albert Michallon

    Grenoble, 38043

  • Hôpital Paris Saint Joseph

    Paris, 75014

  • CHU de Poitiers

    Poitiers, 86021

  • Institut de Cancerologie de lOuest - Rene Gauducheau

    Saint-Herblain, 44805

Other trials in France

Germany5 sites

  • Universitaetsklinikum Aachen

    Aachen, 52074

  • Asklepios Fachkliniken Muenchen-Gauting

    Gauting, 82131

  • Lungenfachklinik Immenhausen

    Immenhausen, 34376

  • Universitaetsmedizin der Johannes Gutenberg-Universitaet

    Mainz, 55131

  • Krankenhaus Bethanien, Medizinische Klinik III

    Moers, 47441

Other trials in Germany

Switzerland5 sites

  • Kantonsspital Aarau

    Aarau, 5001

  • Istituto Oncologico della Svizzera Italiana

    Bellinzona, 06500

  • Hopitaux Universitaires de Geneve

    Geneva, 1211

  • Ospedale Regionale di Locarno La Carita

    Locarno, 06600

  • Kantonsspital St. Gallen

    Sankt Gallen, 9007

Other trials in Switzerland

India4 sites

  • Vedanta Institute of Medical Sciences

    Ahmedabad, Gujarat, 380 009

  • Manipal Hospital

    Bangalore, Karnataka, 560017

  • Tata Memorial Centre

    Mumbai, Maharashtra, 400012

  • Ruby Hall Clinic

    Pune, Maharashtra, 411001

Other trials in India

Ireland4 sites

  • St Vincent's University Hospital

    Dublin, Leinster, Dublin 4

  • Beaumont Hospital

    Dublin, Leinster, Dublin 9

  • St. James Hospital

    Dublin, 8

  • Oncology Department

    Waterford

Other trials in Ireland

Poland4 sites

  • Mazowieckie Centrum Leczenia Chorob Pluc i Gruzlicy

    Otwock, Masovian Voivodeship, 05-400

  • Zoz All-Medi

    Otwock, Masovian Voivodeship, 05-400

  • Centrum Onkologii-Instytut im. Marii Sklodowskiej-Curie

    Warsaw, Masovian Voivodeship, 02-781

  • Nukleomed

    Warsaw, Masovian Voivodeship, 04-736

Other trials in Poland

South Africa4 sites

  • Department of Oncotherapy

    Bloemfontein, 9301

  • GVI Oncology Clinical Research Unit

    Kraaifontein, Western Cape, 7570

  • WCR: Wits Clinical Research

    Parktown,Johannesburg, Gauteng, 2193

  • GVI Oncology

    Port Elizabeth, 6045

Other trials in South Africa

Greece3 sites

  • Sotiria General Hospital of Athens

    Athens, 11527

  • University Hospital of Heraklion

    Heraklion, 71110

  • University Hospital of Larissa

    Larissa, Thessaly, 41110

Other trials in Greece

Slovakia3 sites

  • Univerzitna Nemocnica Bratislava, Klinika pneumologie a ftizeologie I- Oddelenie klinickej onkologie

    Bratislava, 826 06

  • Specializovana nemocnica sv. Svorada Zobor, n.o.

    Nitra, 949 88

  • Fakultna nemocnica s poliklinikou

    Nové Zámky, 94034

Other trials in Slovakia

South Korea3 sites

  • Seoul National University Hospital

    Seoul, 110-744

  • Samsung Medical Center, Clinical Trial Center

    Seoul, 135-710

  • Asan Medical Center, Department of Oncology

    Seoul, 138-736

Other trials in South Korea

Finland2 sites

  • Helsingin yliopistollinen sairaala, Meilahden kolmiosairaala, keuhkosairauksien poliklinikka

    Helsinki, 00290

  • Satakunnan keskussairaala/Keuhkosairauksien osasto A4

    Pori, 28500

Other trials in Finland

Sweden2 sites

  • KPE/Onkologikliniken

    Karlstad, 651 85

  • Karolinska Universitetssjukhuset

    Stockholm, 171 76

Other trials in Sweden

Austria1 site

  • Sozialmedizinisches Zentrum Baumgartner Hoehe - Otto Wagner Spital und Pflegezentrum

    Vienna, 1140

Other trials in Austria

Denmark1 site

  • Aalborg Sygehus Syd

    Aalborg, 9100

Other trials in Denmark

Mexico1 site

  • Oaxaca Site Management Organization

    Oaxaca City, 68000

Other trials in Mexico

About this study

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

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.

Being tested
Dacomitinib (PF-00299804), Active Comparator (erlotinib), Placebo erlotinib, Placebo PF00299804
Keywords
comparative study of PF-00299804 and Erlotinib, Double-Blind Phase 3 trial of TKI
Medical subject headings
Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Dacomitinib (PF-00299804)Drug

    Dacomitinib (PF-00299804) is provided as 45 mg tablets, continuous oral daily dosing

  • Active Comparator (erlotinib)Drug

    Active comparator (erlotinib) provided as 150 mg tablet, continuous oral daily dosing

  • Placebo erlotinibDrug

    placebo erlotinib, provided as 150 mg tablet, continuous oral daily dosing.

  • Placebo PF00299804Drug

    placebo PF-00299804, provide as 45 mg tablet, continuous oral daily dosing

Study groups in NCT01360554
Study groupRoleWhat they receive
AExperimentalBlinded active PF-00299804 + blinded placebo comparator (erlotinib)
Receives: Drug: Dacomitinib (PF-00299804); Drug: Placebo erlotinib
BActive comparatorBlinded active comparator (erlotinib) + blinded placebo PF-00299804
Receives: Drug: Active Comparator (erlotinib); Drug: Placebo PF00299804

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression-Free Survival (PFS) Per Independent Radiologic Review.

    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.

    Measured: 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.

  2. Progression-Free Survival (PFS) Per Independent Radiologic Review in KRAS Wild-type (WT) Participants.

    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.

    Measured: 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 outcomes (15)

  1. PFS Based on Investigator Review.

    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.

    Measured: 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.

  2. PFS Based on Investigator Review in KRAS-WT Participants.

    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.

    Measured: 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.

  3. Overall Survival (OS).

    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).

    Measured: 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.

  4. OS in KRAS-WT Participants.

    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.

    Measured: 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.

  5. Best Overall Response (BOR) Per Independent Radiologic Review.

    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.

    Measured: 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.

  6. BOR Per Investigator Review.

    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.

    Measured: 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.

  7. Duration of Response (DR) Based on Independent Radiologic Review.

    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.

    Measured: 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.

  8. DR Based on Investigator Review.

    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.

    Measured: 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.

  9. Trough Concentrations (Ctrough) of Dacomitinib.

    Mean Ctrough values of dacomitinib observed from Cycle 2 through 5, Day 1 for dose compliant participants.

    Measured: Baseline up to Cycle 5 Day 1

  10. Trough Concentrations (Ctrough) of PF-05199265.

    Mean Ctrough values of PF-05199265 observed from Cycle 2 through 5, Day 1 for dose compliant participants.

    Measured: Baseline up to Cycle 5 Day 1

  11. Time to Deterioration (TTD) in Pain, Dyspnea, Fatigue or Cough Patient Reported Disease Symptoms.

    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.

    Measured: Data taken from Cycle 1 day 1 to the end of treatment or withdrawal.

  12. 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)

    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.

    Measured: Data taken from Cycle 1 day 1 to the end of treatment or withdrawal, averaged (mean) to provide overall scores.

  13. Mean and Difference in Mean in QLQ-C30 Symptoms as Assessed by the EORTC-QLQ-C30.

    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.

    Measured: Data taken from Cycle 1 day 1 to the end of treatment or withdrawal, averaged (mean) to provide overall scores.

  14. Mean and Difference in Mean in Lung Cancer Symptom Scores as Assessed by the EORTC QLQ- LC13.

    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.

    Measured: Data taken from Cycle 1 day 1 to the end of treatment or withdrawal, averaged (mean) to provide overall scores.

  15. Mean and Difference in Mean of the EuroQoL-5 Dimensions (EQ-5D) Visual Analogue Scale (VAS) Score

    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).

    Measured: Data taken from Cycle 1 day 1 to the end of treatment or withdrawal, averaged (mean) to provide overall scores.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 May 2011 (estimated)
  2. Study start16 Jun 2011
  3. Primary completion30 Sep 2013
  4. Study completion14 Sep 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
878 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01360554
Sponsor's protocol ID
A7471009
Other IDs
2010-022656-22
Acronym
ARCHER 1009
Status last verified
Apr 2017
First submitted
12 Apr 2011
Last updated
24 May 2017
Data monitoring committee
Yes

Publications

  • Breen DM, Joaquim S, Paulhus BL, Bennett D, Bernardo B, Collins S, Esquejo RM, Kim-Muller JY, Lin L, Peloquin M, Wu Z, Qiao S, Stansfield JC, Zhang BB, Rossulek MI. Targeting Cancer Cachexia: A Mechanistic Evaluation of Anti-GDF-15 Antibody-Based Combination Therapies. J Cachexia Sarcopenia Muscle. 2026 Jun;17(3):e70312. doi: 10.1002/jcsm.70312.

    PubMed 42126170

  • Ramalingam SS, O'Byrne K, Boyer M, Mok T, Janne PA, Zhang H, Liang J, Taylor I, Sbar EI, Paz-Ares L. Dacomitinib versus erlotinib in patients with EGFR-mutated advanced nonsmall-cell lung cancer (NSCLC): pooled subset analyses from two randomized trials. Ann Oncol. 2016 Mar;27(3):423-9. doi: 10.1093/annonc/mdv593. Epub 2016 Jan 13.

    PubMed 26768165

  • Ramalingam SS, Janne PA, Mok T, O'Byrne K, Boyer MJ, Von Pawel J, Pluzanski A, Shtivelband M, Docampo LI, Bennouna J, Zhang H, Liang JQ, Doherty JP, Taylor I, Mather CB, Goldberg Z, O'Connell J, Paz-Ares L. Dacomitinib versus erlotinib in patients with advanced-stage, previously treated non-small-cell lung cancer (ARCHER 1009): a randomised, double-blind, phase 3 trial. Lancet Oncol. 2014 Nov;15(12):1369-78. doi: 10.1016/S1470-2045(14)70452-8. Epub 2014 Oct 15.

    PubMed 25439691

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Dacomitinib (PF-00299804) and Active Comparator (erlotinib) in people with Non-Small Cell Lung Cancer, run by Pfizer at 224 sites in 23 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 May 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 224 sites in United States, Japan, Spain, Russia, United Kingdom and 18 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 24 May 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01360554, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 May 2017.

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