Clinical trial NCT01360554: ARCHER 1009 : A Study Of Dacomitinib (PF-00299804) Vs. Erlotinib In The Treatment Of Advanced Non-Small Cell Lung Cancer
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Non-Small Cell Lung Cancer
Keywords: comparative study of PF-00299804 and Erlotinib
Double-Blind Phase 3 trial of TKI
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2011-05-25
Enrollment: 878
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a multinational, multicenter, randomized,double-blinded, Phase 3 study comparing the efficacy and safety of treatment with PF-00299804 to treatment with erlotinib in patients with advanced non-small cell lung cancer, previously treated with at least one prior regimen. Analyses of primary objective (Progression Free Survival) will be done in two co-primary populations as defined in the protocol.


Eligibility criteria: Inclusion Criteria:

* Evidence of pathologically confirmed, advanced NSCLC (with known histology).
* Prior treatment with at least one and no more than two systemic therapy regimens (at least one must be standard chemotherapy for advanced NSCLC).
* Adequate tissue sample must be submitted prior to randomization for tumor biomarker analyses.
* Adequate renal, hematologic, liver function.
* ECOG PS of 0-2.
* Radiologically measurable disease.

Exclusion Criteria:

* Small cell histology.
* Symptomatic brain mets or known leptomeningeal mets.
* Prior therapy with agent known or proposed to be active by action on EGFR tyrosine kinase or other HER family proteins.
* Uncontrolled medical disorders.

Primary outcomes:
measure: Progression-Free Survival (PFS) Per Independent Radiologic Review.
timeFrame: 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.
measure: Progression-Free Survival (PFS) Per Independent Radiologic Review in KRAS Wild-type (WT) Participants.
timeFrame: 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:
measure: PFS Based on Investigator Review.
timeFrame: 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.
measure: PFS Based on Investigator Review in KRAS-WT Participants.
timeFrame: 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.
measure: Overall Survival (OS).
timeFrame: 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.
measure: OS in KRAS-WT Participants.
timeFrame: 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.
measure: Best Overall Response (BOR) Per Independent Radiologic Review.
timeFrame: 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.
measure: BOR Per Investigator Review.
timeFrame: 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.
measure: Duration of Response (DR) Based on Independent Radiologic Review.
timeFrame: 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.
measure: DR Based on Investigator Review.
timeFrame: 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.
measure: Trough Concentrations (Ctrough) of Dacomitinib.
timeFrame: Baseline up to Cycle 5 Day 1
measure: Trough Concentrations (Ctrough) of PF-05199265.
timeFrame: Baseline up to Cycle 5 Day 1
measure: Time to Deterioration (TTD) in Pain, Dyspnea, Fatigue or Cough Patient Reported Disease Symptoms.
timeFrame: Data taken from Cycle 1 day 1 to the end of treatment or withdrawal.
measure: 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)
timeFrame: Data taken from Cycle 1 day 1 to the end of treatment or withdrawal, averaged (mean) to provide overall scores.
measure: Mean and Difference in Mean in QLQ-C30 Symptoms as Assessed by the EORTC-QLQ-C30.
timeFrame: Data taken from Cycle 1 day 1 to the end of treatment or withdrawal, averaged (mean) to provide overall scores.
measure: Mean and Difference in Mean in Lung Cancer Symptom Scores as Assessed by the EORTC QLQ- LC13.
timeFrame: Data taken from Cycle 1 day 1 to the end of treatment or withdrawal, averaged (mean) to provide overall scores.
measure: Mean and Difference in Mean of the EuroQoL-5 Dimensions (EQ-5D) Visual Analogue Scale (VAS) Score
timeFrame: Data taken from Cycle 1 day 1 to the end of treatment or withdrawal, averaged (mean) to provide overall scores.
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Florence
country: United States
facility: Northwest Alabama Cancer Center
state: Alabama
city: Mobile
country: United States
facility: University of South Alabama Mitchell Cancer Institute
state: Alabama
city: Mobile
country: United States
facility: University of South Alabama Medical Center
state: Alabama
city: Muscle Shoals
country: United States
facility: Northwest Alabama Cancer Center
state: Alabama
city: Chandler
country: United States
facility: Ironwood physicians P C dba Ironwood Cancer & Research Centers
state: Arizona
city: Chandler
country: United States
facility: Ironwood Physicians P.C. dba Ironwood Cancer and Research Centers
state: Arizona
city: Gilbert
country: United States
facility: Ironwood Physicians P.C. dba Ironwood Cancer and Research Centers
state: Arizona
city: Mesa
country: United States
facility: Desert Oncology Associates dba Ironwood Cancer and Research Centers
state: Arizona
city: Mesa
country: United States
facility: Ironwood Physicians P.C. dba Ironwood Cancer and Research Centers
state: Arizona
city: Fayetteville
country: United States
facility: Highlands Oncology Group PA
state: Arkansas
city: Rogers
country: United States
facility: Highlands Oncology Group, PA
state: Arkansas
city: Alhambra
country: United States
facility: Central Hematology Oncology Medical Group Inc.
state: California
city: Alhambra
country: United States
facility: UCLA Hematology Oncology-Alhambra
state: California
city: Duarte
country: United States
facility: City of Hope
state: California
city: Fullerton
country: United States
facility: St. Jude Heritage Healthcare
state: California
city: Los Angeles
country: United States
facility: Drug Management Only
state: California
city: Los Angeles
country: United States
facility: Drug Managerrent Only:
state: California
city: Los Angeles
country: United States
facility: UCLA West Medical Pharmacy
state: California
city: Los Angeles
country: United States
facility: Administrative Address: UCLA Hematology Oncology-Clinical Research Unit (CRU)
state: California
city: Los Angeles
country: United States
facility: Drug Shipment Address: Ronald Reagan UCLA Medical Center, Drug Information Center
state: California
city: Los Angeles
country: United States
facility: Regulatory Management Only:
state: California
city: Los Angeles
country: United States
facility: Regulatory Management:
state: California
city: Los Angeles
country: United States
facility: Ronald Reagan UCLA Medical Center
state: California
city: Los Angeles
country: United States
facility: TORI Central Administration
state: California
city: Los Angeles
country: United States
facility: Westwood Bowyer Clinic, Peter Morton Medical Building
state: California
city: Pasadena
country: United States
facility: UCLA/Pasadena Healthcare Hematology-Oncology
state: California
city: Pasadena
country: United States
facility: Central Hematology Oncology Medical Group, Inc.
state: California
city: Redondo Beach
country: United States
facility: Cancer Care Associates Medical Group Inc.
state: California
city: Santa Maria
country: United States
facility: Central Coast Medical Oncology Corporation
state: California
city: Santa Monica
country: United States
facility: UCLA Hematology Oncology-Parkside
state: California
city: Santa Monica
country: United States
facility: UCLA Hematology Oncology-Santa Monica
state: California
city: Santa Monica
country: United States
facility: UCLA Santa Monica Medical Center & Orthopedic Hospital
state: California
city: South Pasadena
country: United States
facility: City of Hope South Pasadena Cancer Center
state: California
city: Valencia
country: United States
facility: UCLA/Santa Clarita Valley Cancer Center
state: California
city: Westlake Village
country: United States
facility: UCLA Cancer Center
state: California
city: Norwalk
country: United States
facility: Norwalk Hospital
state: Connecticut
city: Orlando
country: United States
facility: Florida Hospital
state: Florida
city: Orlando
country: United States
facility: Cancer Institute of Florida
state: Florida
city: Orlando
country: United States
facility: Hematology and Oncology Consultants, P.A.
state: Florida
city: Orlando
country: United States
facility: Investigational Drug Services, Florida Hospital
state: Florida
city: Port Saint Lucie
country: United States
facility: Hematology Oncology Associates of the Treasure Coast
state: Florida
city: Atlanta
country: United States
facility: Emory University Hospital Midtown
state: Georgia
city: Atlanta
country: United States
facility: Emory Clinic
state: Georgia
city: Atlanta
country: United States
facility: Emory University Hospital
state: Georgia
city: Atlanta
country: United States
facility: Winship Cancer Institute of Emory University
state: Georgia
city: Austell
country: United States
facility: Northwest Georgia Oncology Centers, P.C.
state: Georgia
city: Carrollton
country: United States
facility: Northwest Georgia Oncology Centers, P.C.
state: Georgia
city: Cartersville
country: United States
facility: Northwest Georgia Oncology Centers, PC
state: Georgia
city: Columbus
country: United States
facility: John B. Amos Cancer Center
state: Georgia
city: Decatur
country: United States
facility: Atlanta Cancer Care
state: Georgia
city: Decatur
country: United States
facility: Georgia Cancer Specialists
state: Georgia
city: Decatur
country: United States
facility: The Cancer Center at DeKalb Medical
state: Georgia
city: Douglasville
country: United States
facility: Northwest Georgia Oncology Centers, P.C.
state: Georgia
city: Duluth
country: United States
facility: Suburban Hematology-Oncology Associates, P.C.
state: Georgia
city: Gainesville
country: United States
facility: Northeast Georgia Medical Center
state: Georgia
city: Gainesville
country: United States
facility: Oncology Specialists of North Georgia, LLC
state: Georgia
city: Gainesville
country: United States
facility: The Longstreet Clinic Cancer Center
state: Georgia
city: Lawrenceville
country: United States
facility: Suburban Hematology-Oncology Associates, P.C.
state: Georgia
city: Marietta
country: United States
facility: Northwest Georgia Oncology Centers, P.C.
state: Georgia
city: Snellville
country: United States
facility: Suburban Hematology-Oncology Associates, P.C.
state: Georgia
city: Arlington Heights
country: United States
facility: Illinois Cancer Specialists
state: Illinois
city: Harvey
country: United States
facility: Ingalls Memorial Hospital - In-Patient Pharmacy
state: Illinois
city: Harvey
country: United States
facility: Ingalls Memorial Hospital
state: Illinois
city: Harvey
country: United States
facility: Monroe Medical Associates
state: Illinois
city: Niles
country: United States
facility: Illinois Cancer Specialists
state: Illinois
city: Tinley Park
country: United States
facility: Monroe Medical Associates
state: Illinois
city: Evansville
country: United States
facility: Deaconess Clinic Downtown
state: Indiana
city: Munster
country: United States
facility: Monroe Medical Associates
state: Indiana
city: Waterloo
country: United States
facility: Cedar Valley Medical Specialists, P.C.
state: Iowa
city: Hazard
country: United States
facility: Kentucky Cancer Clinic
state: Kentucky
city: Louisville
country: United States
facility: University Medical Center, Inc.
state: Kentucky
city: Louisville
country: United States
facility: University Medical Center, Inc
state: Kentucky
city: Louisville
country: United States
facility: Baptist Hospital East
state: Kentucky
city: Detroit
country: United States
facility: Karmanos Cancer Institute
state: Michigan
city: Farmington Hills
country: United States
facility: Karmanos Cancer Institute at Farmington Hills
state: Michigan
city: Starkville
country: United States
facility: North Mississippi Hematology and Oncology Associates, Ltd.
state: Mississippi
city: Tupelo
country: United States
facility: North Mississippi Hematology and Oncology Associates, Ltd.,
state: Mississippi
city: Creve Coeur
country: United States
facility: Siteman Cancer Center-West County
state: Missouri
city: Saint Louis
country: United States
facility: Barnes Jewish Hospital
state: Missouri
city: Saint Louis
country: United States
facility: Washington University School of Medicine-IDS Pharmacy
state: Missouri
city: Saint Peters
country: United States
facility: Siteman Cancer Center-St. Peters
state: Missouri
city: Lebanon
country: United States
facility: Dartmouth-Hitchcock Medical Center /Mary Hitchcock Memorial Hospital
state: New Hampshire
city: Denville
country: United States
facility: Oncology and Hematology Specialists, P.A.
state: New Jersey
city: Stony Brook
country: United States
facility: Stony Brook University-Cancer Center
state: New York
city: Hickory
country: United States
facility: Carolina Oncology Specialists PA
state: North Carolina
city: Lenoir
country: United States
facility: Carolina Oncology Specialists PA
state: North Carolina
city: Norman
country: United States
facility: Mercy clinic oklahoma communities, Inc. - Mercy clinic oncology/Hematology - Norman
state: Oklahoma
city: Oklahoma City
country: United States
facility: Mercy Physicians of Oklahoma-Communities, Inc. - Mercy Clinic Oncology/Hematology - McAuley
state: Oklahoma
city: Oklahoma City
country: United States
facility: Mercy Hospital Oklahoma City - Oncology Infusion
state: Oklahoma
city: Corvallis
country: United States
facility: Good Samaritan Hospital Samaritan Ambulatory Infusion Services
state: Oregon
city: Corvallis
country: United States
facility: Samaritan Hematology & Oncology Consultants
state: Oregon
city: Corvallis
country: United States
facility: Samaritan Pharmacy Services
state: Oregon
city: Lincoln City
country: United States
facility: Samaritan North Lincoln Hospital
state: Oregon
city: Newport
country: United States
facility: Samaritan Pacific Communities Hospital
state: Oregon
city: Sayre
country: United States
facility: Guthrie Clinic, Limited
state: Pennsylvania
city: Sayre
country: United States
facility: Robert Packer Hospital
state: Pennsylvania
city: Longview
country: United States
facility: Texas Oncology-Longview Cancer Center
state: Texas
city: Tyler
country: United States
facility: Texas Oncology-Tyler
state: Texas
city: Waco
country: United States
facility: Texas Oncology - Waco
state: Texas
city: Kennewick
country: United States
facility: Kadlec Clinic Hematology and Oncology
state: Washington
city: Richland
country: United States
facility: Kadlec Medical Center
state: Washington
city: Richland
country: United States
facility: Outpatient Imaging Center
state: Washington
city: Seattle
country: United States
facility: Seattle Cancer Care Alliance
state: Washington
city: Seattle
country: United States
facility: University of Washington Medical Center
state: Washington
city: Vienna
country: Austria
facility: Sozialmedizinisches Zentrum Baumgartner Hoehe - Otto Wagner Spital und Pflegezentrum
city: Brussels
country: Belgium
facility: Institut Jules Bordet
city: Brussels
country: Belgium
facility: Laboratoire de la Porte de Hall
city: Charleroi
country: Belgium
facility: Grand Hopital de Charleroi Oncologie-Hematologie
city: Mons
country: Belgium
facility: CHU Ambroise Parre- Service Biologie Clinique
city: Roeselare
country: Belgium
facility: Heilig Hart Ziekenhuis Roeselare-Menen
city: Nanning
country: China
facility: Tumour Hospital of Guangxi Zhuang Autonomous Region
state: Guangxi
city: Wuhan
country: China
facility: Union Hospital, Tongji Medical College of Huazhong University of Science & Technology/Cancer Center
state: Hubei
city: Changchun
country: China
facility: Jilin Provincial Cancer Hospital
state: Jilin
city: Chengdu
country: China
facility: West China Hospital of Sichuan University
state: Sichuan
city: Shanghai
country: China
facility: Shanghai Pulmonary Hospital
city: Aalborg
country: Denmark
facility: Aalborg Sygehus Syd
city: Helsinki
country: Finland
facility: Helsingin yliopistollinen sairaala, Meilahden kolmiosairaala, keuhkosairauksien poliklinikka
city: Pori
country: Finland
facility: Satakunnan keskussairaala/Keuhkosairauksien osasto A4
city: Dijon
country: France
facility: Centre Georges Francois Leclerc
city: Grenoble cedex 09
country: France
facility: Hopital Albert Michallon
city: Paris
country: France
facility: Hôpital Paris Saint Joseph
city: Poitiers Cedex
country: France
facility: CHU de Poitiers
city: Saint Herblain cedex
country: France
facility: Institut de Cancerologie de lOuest - Rene Gauducheau
city: Aachen
country: Germany
facility: Universitaetsklinikum Aachen
city: Gauting
country: Germany
facility: Asklepios Fachkliniken Muenchen-Gauting
city: Immenhausen
country: Germany
facility: Lungenfachklinik Immenhausen
city: Mainz
country: Germany
facility: Universitaetsmedizin der Johannes Gutenberg-Universitaet
city: Moers
country: Germany
facility: Krankenhaus Bethanien, Medizinische Klinik III
city: Larissa
country: Greece
facility: University Hospital of Larissa
state: Thessaly
city: Athens
country: Greece
facility: Sotiria General Hospital of Athens
city: Heraklion
country: Greece
facility: University Hospital of Heraklion
city: Budapest
country: Hungary
facility: Semmelweis Egyetem Pulmonologiai Klinika
city: Debrecen
country: Hungary
facility: Debreceni Egyetem Orvos- es Egeszsegtudomanyi Centrum
city: Farkasgyepu
country: Hungary
facility: Veszprem Megyei Onkormanyzat Tudogyogyintezete
city: Gyula
country: Hungary
facility: Pandy Kalman Megyei Korhaz, Aktiv Tudogyogyaszat
city: Nyiregyhaza
country: Hungary
facility: Josa Andras Oktatokorhaz Egeszsegugyi Szolgaltato Nonprofit Kft.
city: Zalaegerszeg-Pozva
country: Hungary
facility: Zala Megyei Korhaz, Pulmonologiai Osztaly
city: Ahmedabad
country: India
facility: Vedanta Institute of Medical Sciences
state: Gujarat
city: Bangalore
country: India
facility: Manipal Hospital
state: Karnataka
city: Mumbai
country: India
facility: Tata Memorial Centre
state: Maharashtra
city: Pune
country: India
facility: Ruby Hall Clinic
state: Maharastra
city: Dublin
country: Ireland
facility: St Vincent's University Hospital
state: Leinster
city: Dublin
country: Ireland
facility: Beaumont Hospital
state: Leinster
city: Dublin
country: Ireland
facility: St. James Hospital
city: Waterford
country: Ireland
facility: Oncology Department
city: Nagoya
country: Japan
facility: Aichi cancer center central hospital /Thoracic Oncology
state: Aichi
city: Kashiwa
country: Japan
facility: National Cancer Center Hospital East
state: Chiba
city: Matsuyama-city
country: Japan
facility: National Hospital Organization Shikoku Cancer Center
state: Ehime
city: Asahikawa
country: Japan
facility: National Hospital Organization Asahikawa Medical Center
state: Hokkaido
city: Akashi
country: Japan
facility: Hyogo Cancer Center
state: Hyogo
city: Kanazawa city
country: Japan
facility: Kanazawa University Hospital
state: Ishikawa
city: Yokohama
country: Japan
facility: Kanagawa Cardiovascular and Respiratory Center
state: Kanagawa
city: Sendai
country: Japan
facility: Tohoku University Hospital
state: Miyagi
city: Kurashiki
country: Japan
facility: Kurashiki Central Hospital
state: Okayama
city: Okayama-city
country: Japan
facility: Okayama University Hospital
state: Okayama
city: Sakai-Shi
country: Japan
facility: National Hospital Organization Kinki-chuo Chest Medical Center
state: Osaka-fu
city: Osaka-city
country: Japan
facility: Osaka City General Hospital Department of Clinical Oncology
state: Osaka
city: Osakasayama-shi
country: Japan
facility: Kinki University Hospital
state: Osaka
city: Sunto-gun
country: Japan
facility: Shizuoka Cancer Center
state: Shizuoka
city: Chuo-Ku
country: Japan
facility: National Cancer Center Hospital
state: Tokyo
city: Ube-shi
country: Japan
facility: National Hospital Organization, Yamaguchi-Ube Medical Center
state: Yamaguchi
city: Fukuoka
country: Japan
facility: National Hp. Org. Kyushu Medical Center
city: Fukuoka
country: Japan
facility: National Hospital Organization Kyushu Cancer Center/Department of Thoracic Oncology
city: Fukuoka
country: Japan
facility: Kyushu University Hospital Respiratory Medicine
city: Koto-ku, Tokyo
country: Japan
facility: The Cancer Institute Hospital of JFCR
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center, Clinical Trial Center
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center, Department of Oncology
city: Oaxaca
country: Mexico
facility: Oaxaca Site Management Organization
city: Otwock
country: Poland
facility: Mazowieckie Centrum Leczenia Chorob Pluc i Gruzlicy
state: Mazowieckie
city: Otwock
country: Poland
facility: Zoz All-Medi
state: Mazowieckie
city: Warsaw
country: Poland
facility: Centrum Onkologii-Instytut im. Marii Sklodowskiej-Curie
state: Mazowieckie
city: Warsaw
country: Poland
facility: Nukleomed
state: Mazowieckie
city: Krasnodar
country: Russian Federation
facility: City Hospital #2 Krasnodar Multi-Field Diagnostic and Treatment Association
state: Krasnodarskij Kraj
city: Sochi
country: Russian Federation
facility: Oncology Center # 2
state: Krasnodarskij Kraj
city: Pyatigorsk
country: Russian Federation
facility: Federal State Healthcare Clinical Hospital #101 of the Federal Biomedical Agency
state: Stavropolskij Kraj
city: Pyatigorsk
country: Russian Federation
facility: Pyatigorsk Oncology Center
city: Saint-Petersburg
country: Russian Federation
facility: Clinic of Hospital Surgery
city: Saint-Petersburg
country: Russian Federation
facility: Military Medical Academy n.a. S.M.Kirov
city: Saint-Petersburg
country: Russian Federation
facility: City Clinical Oncology Dispensary
city: Saint-Petersburg
country: Russian Federation
facility: St.-Petersburg State Medical University I.P.Pavlov of Roszdrav
city: Saint-Petersburg
country: Russian Federation
facility: Research Institute of Pulmonology
city: Saint-Petersburg
country: Russian Federation
facility: Russian Scientific Center of Radiology and Surgical Technologies
city: Saint-Petersburg
country: Russian Federation
facility: City Clinical Oncology Dispensary
city: Samara
country: Russian Federation
facility: Samara Regional Clinical Oncology Dispensary
city: Bratislava
country: Slovakia
facility: Univerzitna Nemocnica Bratislava, Klinika pneumologie a ftizeologie I- Oddelenie klinickej onkologie
city: Nitra
country: Slovakia
facility: Specializovana nemocnica sv. Svorada Zobor, n.o.
city: Nove Zamky
country: Slovakia
facility: Fakultna nemocnica s poliklinikou
city: Parktown,Johannesburg
country: South Africa
facility: WCR: Wits Clinical Research
state: Gauteng
city: Kraaifontein
country: South Africa
facility: GVI Oncology Clinical Research Unit
state: Western Cape
city: Bloemfontein
country: South Africa
facility: Department of Oncotherapy
city: Port Elizabeth
country: South Africa
facility: GVI Oncology
city: Elche
country: Spain
facility: Hospital General Universitario de Elche - Edificio UIAE
state: Alicante
city: Badalona
country: Spain
facility: Hospital Universitari Germans Trias i Pujol
state: Barcelona
city: Castellón
country: Spain
facility: Hospital Provincial de Castellon - Servicio de Oncologia
state: Castellon
city: Barcelona
country: Spain
facility: HOSPITAL DE LA SANTA CREU I SANT PAU - Pharmacy
city: Barcelona
country: Spain
facility: Hospital de la Santa Creu i Sant Pau - AGDAC
city: Barcelona
country: Spain
facility: Hospital de la Santa Creu i Sant Pau - Anatomia Patológica
city: Barcelona
country: Spain
facility: Hospital de la Santa Creu i Sant Pau - Diagnostic per la Imatge i Med. Nuclear
city: Barcelona
country: Spain
facility: Hospital de la Santa Creu i Sant Pau - Hospital de Día
city: Barcelona
country: Spain
facility: Hospital de la Santa Creu i Sant Pau
city: Castellon
country: Spain
facility: Hospital Provincial de Castellon (Farmacia)
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre-Radiology
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre01
city: Madrid
country: Spain
facility: Hospital Universitario Madrid Sanchinarro
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen del Rocio. Hospital General Planta Baja. Servicio de Oncologia.
city: Karlstad
country: Sweden
facility: KPE/Onkologikliniken
city: Stockholm
country: Sweden
facility: Karolinska Universitetssjukhuset
city: Aarau
country: Switzerland
facility: Kantonsspital Aarau
city: Bellinzona
country: Switzerland
facility: Istituto Oncologico della Svizzera Italiana
city: Geneve 14
country: Switzerland
facility: Hopitaux Universitaires de Geneve
city: Locarno
country: Switzerland
facility: Ospedale Regionale di Locarno La Carita
city: St. Gallen
country: Switzerland
facility: Kantonsspital St. Gallen
city: Maidstone
country: United Kingdom
facility: Kent Oncology Centre
state: Kent
city: Wolverhampton
country: United Kingdom
facility: New Cross Hospital - Royal Wolverhampton Hospital NHS Trust
state: West Midlands
city: Edmonton
country: United Kingdom
facility: North Middlesex NHS Trust
city: Leicester
country: United Kingdom
facility: Leicester Royal Infirmary
city: London
country: United Kingdom
facility: Cancer Clinical Trials Unit
city: Manchester
country: United Kingdom
facility: Christie Hospital NHS Trust, Department of Medical Oncology
city: Manchester
country: United Kingdom
facility: Christie Hospital NHS Trust
city: Manchester
country: United Kingdom
facility: Lung and Melanoma Research Team
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.