A Study of Tarceva After Surgery With or Without Adjuvant Chemotherapy in Non-Small Cell Lung Carcinoma (NSCLC) Patients Who Have Epidermal Growth Factor Receptor (EGFR) Positive Tumors (RADIANT)

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Astellas Pharma Inc ( OSI Pharmaceuticals )
ClinicalTrials.gov Identifier:
First received: September 7, 2006
Last updated: January 6, 2014
Last verified: January 2014

This is a study to evaluate the effectiveness of Tarceva (erlotinib) vs. placebo sugar pill following complete surgical removal of the tumor with or without chemotherapy after surgery in Stage IB-IIIA NSCLC patients.

Condition Intervention Phase
Non-small Cell Lung Cancer
Drug: Tarceva
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Multi-center, Randomized, Double-blind, Placebo-controlled, Phase 3 Study of Single-agent Tarceva® (Erlotinib) Following Complete Tumor Resection With or Without Adjuvant Chemotherapy in Patients With Stage IB-IIIA Non-small Cell Lung Carcinoma Who Have EGFR-positive Tumors

Resource links provided by NLM:

Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:
  • Disease Free Survival (DFS) [ Time Frame: Every 3 months during active phase and every 6 months during long term follow-up (up to 6 years) ] [ Designated as safety issue: No ]
    DFS is the time from the date of randomization until the first day NSCLC relapse is documented by radiological exam and/or biopsy, or until death in the absence of relapse.

Secondary Outcome Measures:
  • Overall Survival (OS) [ Time Frame: Every 3 months during active phase and every 6 months during long term follow-up up to 5 years and yearly thereafter (up to 10 years) ] [ Designated as safety issue: No ]
    Survival will be defined as the time from the date of randomization until the documented date of death.

  • DFS in patients with EGFR mutation - positive tumors [ Time Frame: Every 3 months during active phase and every 6 months during long term follow-up (up to 6 years) ] [ Designated as safety issue: No ]
    DFS is the time from the date of randomization until the first day NSCLC relapse is documented by radiological exam and/or biopsy, or until death in the absence of relapse.

  • OS in patients with EGFR mutation - positive tumors [ Time Frame: Every 3 months during active phase and every 6 months during long term follow-up up to 5 years and yearly thereafter (up to 10 years) ] [ Designated as safety issue: No ]
    Survival will be defined as the time from the date of randomization until the documented date of death.

  • Safety assessed through Adverse Events (AEs), laboratory values, physical examinations and Eastern Cooperative Oncology Group Performance Status (ECOG PS) [ Time Frame: Every 3 months during active phase and every 6 months during long term follow-up up to 5 years and yearly thereafter (up to 10 years) ] [ Designated as safety issue: No ]

Enrollment: 1252
Study Start Date: September 2006
Estimated Study Completion Date: June 2016
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Tarceva
150mg Daily
Drug: Tarceva
150mg Tablet
Other Names:
  • OSI-774
  • erlotinib
Placebo Comparator: Placebo
Matching Placebo Daily
Drug: Placebo
Placebo Tablet


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Primary tissue from patient's surgery must be Epidermal growth factor receptor (EGFR)-positive by certain tests
  • Patients may have up to 4 cycles of chemotherapy after surgery
  • Complete removal of the tumor by surgery
  • Able to start drug under the following timelines:

    • 6 months from the day of surgery for patients who get chemotherapy
    • 3 months from the day of surgery for those who do not get chemotherapy
  • Confirmed diagnosis of Stage IB-IIIA NSCLC
  • Patients must be accessible for follow-up visits

Exclusion Criteria:

  • History of prior radiotherapy for NSCLC either before or after surgery
  • History of heart disease or uncontrolled heart arrhythmias within the previous year
  • History of poorly controlled Gastrointestinal (GI) disorders that could affect the absorption of study drug
  • History of other cancer except certain skin or cervical cancers, Patients who have had other cancer are eligible if they have remained disease free for at least 5 years
  • Patients who have received chemotherapy for NSCLC before surgery
  • Tumors with mixed histology of NSCLC and Small Cell Lung Cancer (SCLC). Patients with carcinoid tumors are not eligible
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00373425

  Hide Study Locations
United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
United States, Arizona
Arizona Cancer Center
Tucson, Arizona, United States, 85724
United States, Arkansas
University of Arkansas for Medical Science
Little Rock, Arkansas, United States, 72205
United States, California
Tower Cancer Research Foundation
Beverly Hills, California, United States, 90211
City of Hope Nat`l Medical Center
Duarte, California, United States, 91010
Loma Linda University Medical Center
Loma Linda, California, United States, 92354
USC/ Norris Comprehensive Cancer Center
Los Angeles, California, United States, 90033
USC/ Norris Comprehensive Cncer Center
Los Angeles, California, United States, 90033
Cedars-Sinai Outpatient Cancer Center
Los Angeles, California, United States, 90048
Hoag Cancer Center
Newport Beach, California, United States, 92658
Comprehensive Cancer Center at Desert Regional Medical Center
Palm Springs, California, United States, 92262
Bay Area Cancer Research Group, LLC
Pleasant Hill, California, United States, 94523
University of California, San Francisco Comprehensive Cancer Center
San Francisco, California, United States, 94143-1770
City of Hope Medical Group (COHMG)
South Pasadena, California, United States, 91030
United States, Colorado
Rocky Mountain Cancer Center- Aurora
Aurora, Colorado, United States, 80012
Rocky Mountain Cancer Centers-Boulder
Boulder, Colorado, United States, 80303
Rocky Mountain Cancer Center
Colorado Springs, Colorado, United States, 80909
Rocky Mountain Cancer Center
Colorado Springs, Colorado, United States, 80907
Rocky Mountain Cancer Center-Midtown
Denver, Colorado, United States, 80218
Rocky Mountain Cancer Centers- Rose
Denver, Colorado, United States, 80220
Rocky Mountain Cancer Centers
Lakewood, Colorado, United States, 80228
Rocky Mountain Cancer Centers-Littleton
Littleton, Colorado, United States, 80120-4413
Rocky Mountain Cancer Center-Sky Ridge
Lone Tree, Colorado, United States, 80124
Rocky Mountain Cancer Centers-Longmont
Longmont, Colorado, United States, 80501
Rocky Mountain Cancer Center-Parker
Parker, Colorado, United States, 80138
Rocky Mountain Cancer Centers-Pueblo
Pueblo, Colorado, United States, 81008
Rocky Mountain Cancer Centers
Thornton, Colorado, United States, 80260
United States, Connecticut
Connecticut Oncology & Hematology, LLP
New Milford, Connecticut, United States, 06776
Connecticut Oncology & Hematology, LLP
Sharon, Connecticut, United States, 06069
Hematology Oncology, P.C.
Stamford, Connecticut, United States, 06902
Connecticut Oncology & Hematology, LLP
Torrington, Connecticut, United States, 06790
United States, Florida
Florida Cancer Institute-New Hope
Hudson, Florida, United States, 34667
Integrated Community Oncology Network, Division of Clinical Research
Jacksonville, Florida, United States, 32216
Integrated Community Oncology Network
Jacksonville, Florida, United States, 32204
Watson Clinic LLP
Lakeland, Florida, United States, 33805
Advanced Medical Specialties
Miami, Florida, United States, 33176
Florida Cancer Institute- New Hope
New Port Richey, Florida, United States, 34655
Cancer Centers of Florida, PPA
Ocoee, Florida, United States, 34761
Integrated Community Oncology Network
Orange Park, Florida, United States, 32073
Cancer Centers of Florida
Orlando, Florida, United States, 32806
Hematology Oncology Associates of the Treasure Coast
Port St. Lucie, Florida, United States, 34952
Cancer Centers of Florida
Winter Park, Florida, United States, 32789
United States, Georgia
Peachtree Hematology-Oncology Consultants, P.C.
Atlanta, Georgia, United States, 30309
Central Georgia Cancer Care, PC
Macon, Georgia, United States, 31201
Northwest Georgia Oncology Centers, PC
Marietta, Georgia, United States, 30060
United States, Idaho
Mountain States Tumor Institute
Boise, Idaho, United States, 83712
Mountain States Tumor Institute
Fruitland, Idaho, United States, 83619
Kootenai Cancer Center
Post Falls, Idaho, United States, 83854
Mountain States Tumor Institute
Twin Falls, Idaho, United States, 83301
United States, Illinois
Rush University Medical Center
Chicago, Illinois, United States, 60612
University of Chicago, Section of Hematology/Oncology MC2115
Chicago, Illinois, United States, 60637
Joliet Oncology Hematology Assoc., LTD
Joliet, Illinois, United States, 60435
Loyola University Medical Center
Maywood, Illinois, United States, 60153
United States, Indiana
Central Indiana Cancer Centers
Carmel, Indiana, United States, 46032
Central Indiana Cancer Centers
Fishers, Indiana, United States, 46037
Central Indiana Cancer Centers
Greenfield, Indiana, United States, 46140
Central Indiana Cancer Centers
Indianapolis, Indiana, United States, 46227
Central Indiana Cancer Centers
Indianapolis, Indiana, United States, 46219
United States, Kansas
University of Kansas Hospital
Westwood, Kansas, United States, 66205
United States, Kentucky
Norton Healthcare, Inc.
Louisville, Kentucky, United States, 40202
United States, Louisiana
Leonard J. Chabert Medical Center; Pulmonary
Houma, Louisiana, United States, 70363
United States, Maine
Cancer Care of Maine
Brewer, Maine, United States, 04412
United States, Maryland
Greater Baltimore Medical Center
Baltimore, Maryland, United States, 21204
St. Joseph Medical Center`s Cancer Institute
Towson, Maryland, United States, 21204
United States, Massachusetts
Caritas St. Elizabeth's Medical Center
Boston, Massachusetts, United States, 02135
United States, Michigan
St. Joseph Mercy Hospital
Ann Arbor, Michigan, United States, 48106
United States, Minnesota
Minnesota Oncology Hematology, P.A.
Burnsville, Minnesota, United States, 55337
Minnesota Oncology Hematology, P.A.
Edina, Minnesota, United States, 55435-2150
Minnesota Oncology Hematology, P.A.
Maplewood, Minnesota, United States, 55109
Minnesota Oncology Hematology, P.A.
Minneapolis, Minnesota, United States, 55404
Minnesota Oncology Hematology
St. Paul, Minnesota, United States, 55102-2389
Minnesota Oncology Hematology, P.A.
Woodbury, Minnesota, United States, 55125
United States, Missouri
Missouri Cancer Associates
Columbia, Missouri, United States, 65201
St. Joseph Oncology, Inc.
St. Joseph, Missouri, United States, 64507
United States, Nebraska
St. Francis Medical Center
Grand Island, Nebraska, United States, 68803
Nebraska Methodist Hospital
Omaha, Nebraska, United States, 68114
United States, Nevada
Comprehensive Cancer Centers of Nevada
Henderson, Nevada, United States, 89052
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, United States, 89169
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, United States, 89128
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, United States, 89148
United States, New Hampshire
NH Oncology-Hematology PA (Co)
Concord, New Hampshire, United States, 03301
NH Oncology-Hematology PA
Hooksett, New Hampshire, United States, 03106
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756
United States, New Jersey
Hackensack University Medical Center
Hackensack, New Jersey, United States, 07601
United States, New Mexico
University of New Mexico
Albuquerque, New Mexico, United States, 87131
New Mexico Cancer Care, Cancer Institute of New Mexico
Santa Fe, New Mexico, United States, 87505
St. Vincent Regional Cancer Care Center
Santa Fe, New Mexico, United States, 87505
United States, New York
Interlakes Oncology Hematology, PC
Brockport, New York, United States, 14420
Montefiore Medical Center
Bronx, New York, United States, 10467
Interlakes Oncology Hematology, PC
Canadaigua, New York, United States, 14424
Interlakes Oncology Hematology, PC
Geneva, New York, United States, 14456
The New York Presbyterian-Weill Medical College of Cornell University
New York, New York, United States, 10065
Interlakes Oncology Hematology, PC
Rochester, New York, United States, 14623
Interlakes Oncology Hematology, PC
Rochester, New York, United States, 14626
State University of New York at Stony Brook
Stony Brook, New York, United States, 11794
United States, North Carolina
Raleigh Hematology Oncology Associates
Cary, North Carolina, United States, 27511
Mecklenburg Medical Group
Charlotte, North Carolina, United States, 28211
Raleigh Hematology Oncology Associates
Raleigh, North Carolina, United States, 27607
Raleigh Hematology Oncology Associates
Raleigh, North Carolina, United States, 27609
United States, Ohio
Aultman Hospital/ North Canton Medical Foundation
Canton, Ohio, United States, 44710
University Hopsitals of Cleveland
Cleveland, Ohio, United States, 44106
Hematology Oncology Consultants Inc.
Columbus, Ohio, United States, 43228
United States, Oregon
Earle A Chiles Research Institute
Portland, Oregon, United States, 97213
Northwest Cancer Specialists, PC
Portland, Oregon, United States, 97225
Northwest Cancer Specialists, PC
Portland, Oregon, United States, 97227
Northwest Cancer Specialists, PC
Portland, Oregon, United States, 97213
Northwest Cancer Specialists, PC
Tualatin, Oregon, United States, 97062
United States, Pennsylvania
Cancer Care Associates - Mediacl Oncology
Bethlehem, Pennsylvania, United States, 18015
The Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Allegheny General Hospital - Allegheny Singer Research Institute
Pittsburg, Pennsylvania, United States, 15212
United States, South Carolina
South Carolina Oncology Assoc., PA
Columbia, South Carolina, United States, 29210
Cancer Centers of the Carolinas
Easley, South Carolina, United States, 29640
Cancer Centers of the Carolinas
Greenville, South Carolina, United States, 29605
Cancer Centers of the Carolinas
Greenville, South Carolina, United States, 29615
Cancer Centers of the Carolinas, Seneca
Seneca, South Carolina, United States, 29672
Cancer Centers of the Carolinas
Spartanburg, South Carolina, United States, 29307
United States, Tennessee
Family Cancer Center, PLLC
Collierville, Tennessee, United States, 38017
Cookeville Regional Medical Center
Cookeville, Tennessee, United States, 38501
University of Tennessee Cancer Institute
Germantown, Tennessee, United States, 38138
Tennessee Cancer Specialists
Knoxville, Tennessee, United States, 37909
West Clinic
Memphis, Tennessee, United States, 38120
Family Cancer Center, PLLC
Memphis, Tennessee, United States, 38119
University of Tennessee Cancer Institute
Memphis, Tennessee, United States, 38104
Sarah Cannon Cancer Center
Nashville, Tennessee, United States, 37203
Sarah Cannon Research Institute
Nashville, Tennessee, United States, 37203
United States, Texas
Texas Oncology, P.A. - Amarillo
Amarillo, Texas, United States, 79106
Texas Oncology Beaumont
Beaumont, Texas, United States, 77702-1449
Texas Oncology
Dallas, Texas, United States, 75246
Texas Oncology Texas Cancer Center at Medical City
Dallas, Texas, United States, 75230-2510
Southwest Forth Worth Cancer Center
Fort Worth, Texas, United States, 76132
Texas Oncology, Fort Worth
Ft. Worth, Texas, United States, 76104
Texas Oncology, P.A.
Garland, Texas, United States, 75042-5788
Lake Vista Cancer Center
Lewisville, Texas, United States, 75067
Cancer Care Centers of South Texas - HOAST
New Braunfels, Texas, United States, 78131
Paris Regional Cancer Center
Paris, Texas, United States, 75460-5004
North Texas Regional Cancer Center
Plano, Texas, United States, 75075-7787
Cancer Care Centers of South Texas-HOAST
San Antonio, Texas, United States, 78229
Texas Oncology -Tyler
Tyler, Texas, United States, 75702
Texas Oncology Cancer Care and Researh Center
Waco, Texas, United States, 76712
United States, Virginia
Onc and Hem Associates of SW VA, Inc.
Christiansburg, Virginia, United States, 24073
Virginia Oncology Associates
Hampton, Virginia, United States, 23666
Virginia Oncology Associates
Newport News, Virginia, United States, 23606
Virginia Oncology Associates
Norfolk, Virginia, United States, 23502
Onc and Hem Associates of SW VA, Inc.
Roanoke, Virginia, United States, 24014
Onc and Hem Assoc of SW VA, Inc
Salem, Virginia, United States, 24153
Onc and Hem Associates of SW VA, Inc.
Wytheville, Virginia, United States, 24382
United States, Washington
Univ. of Washington/ Seattle Cancer Care Alliance
Seattle, Washington, United States, 98109
Cancer Care Northwest
Spokane, Washington, United States, 99202
Cancer Care Northwest-North
Spokane, Washington, United States, 99218
Cancer Care Northwest-Valley
Spokane Valley, Washington, United States, 99216
Northwest Cancer Specialists-Vancouver
Vancouver, Washington, United States, 98684
Northwest Cancer Specialist, P.C.
Vancouver, Washington, United States, 98686
Hospital Italiano de Buenos Aires
Buenos Aires, Argentina, C1181ACH
Hospital de Rehabilitación Respiratoria María Ferrer
Buenos Aires, Argentina, C1272AAA
Mendoza, Argentina, M5500AYB
Hospital Espanol de Rosario
Rosario, Santa Fe, Argentina, S2001SBL
ISIS Centro Especializado De Luce S.A.
Santa Fé, Argentina, S3000FFU
Australia, New South Wales
Campbelltown Hospital
Campbelltown, New South Wales, Australia, 2560
Liverpool Hospital
Liverpool, New South Wales, Australia, 2170
Royal North Shore Hospital
St Leonards, New South Wales, Australia, 2065
Australia, Victoria
Monash Medical Centre
East Bentleigh, Victoria, Australia, 3165
St Vincent`s Hospital Melbourne
Fitzroy, Victoria, Australia, 3065
Austin & Repatriation Medical Centre
Heidelberg, Victoria, Australia, 3084
Respiratory Research Foundation Ltd
Adelaide, Australia, 5067
Ashford Cancer Centre
Ashford, Australia, SA 5037
Universitaetsklinikum Innsbruck
Innsbruck, Austria, 6020
Allgemeines Krankenhaus der Stadt Linz
Linz, Austria, 4021
Landeskrankenhaus SalzburgUniversitaetsklinikum der PMUUniversitaetsklinik für Pneumologie
Salzburg, Austria, 5020
SMZ Baumgartner Hoehe - Otto Wagner Spital
Wien, Austria, 1140
SMZ Baumgartner Höhe - Otto- Wagner-Spital
Wien, Austria, A-1140
Krankenhaus Hietzing
Wien, Austria, 1130
AKH Wien
Wien, Austria, 1090
Cliniques Universitaires Saint-Luc
Brussels, Belgium, 1200
Hôpital Erasme
Brussels, Belgium, 1070
Centre Hospitalier Jolimont-Lobbes
La Louvière, Belgium, 7100
Canada, Alberta
Cross Cancer Institute
Edmonton, Alberta, Canada, T6G 1Z2
Canada, Ontario
Cancer Center of Southeastern Ontario at Kingston General Hospital
Kingston, Ontario, Canada, K7L 5P9
Credit Valley Hospital
Mississauga, Ontario, Canada, L5M 2N1
Stronach Regional cancer Centre at Southlake
Newmarket, Ontario, Canada, L3Y 2P9
RS MacLaughlin Durham Regional Cancer Centre
Oshawa, Ontario, Canada, L1G 2B9
Sault Area Hospital
Sault Ste Marie, Ontario, Canada, P6A 5K7
Thunder Bay Regional Health Science Centre
Thunder Bay, Ontario, Canada, P7B 6V4
Toronto General Hospital
Toronto, Ontario, Canada, M5G 2C4
Canada, Quebec
Montreal General Hospital
Montreal, Quebec, Canada, H3G 1A4
McGill Dept. of Oncology
Montreal, Quebec, Canada, H2W 1S6
Royal Victoria Hospital
Montreal, Quebec, Canada, H3A 1A1
St. Joseph's Health Centre
Toronto, Canada, M6R 1B5
Czech Republic
Nemocnice Ceske Budejovice, a.s.
Ceske Budejovice, Czech Republic, 370 87
Fakultni nemocnice OstravaKlinika tuberkulozy a respiracnich nemoci
Ostrava-Poruba, Czech Republic, 70852
FN Bulovka Klinika plincni a hrrudni chirurgie
Praha, Czech Republic, 8 18081
CHU Larrey Service de Pneumologie, Clinique des vois respiratoires
Toulouse, Cedex 9, France, 31059
Centre d`oncologie et de radiothérapie du Pays Basque
Bayonne, France, 64100
C.H.U. Morvan, Institut de Cancerologie et d`Hématologie
Brest cedex, France, 29609
CHU de CAEN - Service de pneumologie
CAEN Cedex, France, 14033
CHU Clermont Ferrand - Hôpital Gabriel Montpied - Service de pneumologie
Clermont-Ferrand cedex 1, France, 63003
Hopital De La Croix-Rousse Service de Pneumologie
Lyon cedex 04, France, 69317
Hôpital St Antoine - Service de pneumologie
Paris, France, 75012
Fondation Hôpital Saint Joseph
PARIS cedex 14, France, 75014
Centre Catalan d'Oncologie
Perpignan, France, 66000
CHU - Hopital Pontchaillou - Service de pneumologie
Rennes cedex 9, France, 35033
Institut de Cancérologie de la Loire
Saint Priest en Jarez, France, 42271
Hôpital de Brabois
Vandoeuvre-lès-Nancy Cedex, France, 54511
Zentralklinik Bad Berka
Bad Berka, Germany, 99437
HELIOS Klinikum Emil von Behring GmbH
Berlin, Germany, 14165
Augusta-Krankenanstalt Bochum
Bochum, Germany, 44791
Fachkrankenhaus Coswig
Coswig, Germany, 01640
Universitaetsklinikum Essen
Essen, Germany, 45122
Krankenhaus Nordwest
Frankfurt/Main, Germany, 60488
Universitätsklinikum Freiburg
Freiburg, Germany, 79106
Krankenhaus Großhansdorf
Großhansdorf, Germany, 22927
Universitätsklinikum Göttingen
Göttingen, Germany, 37075
Städtisches Krankenhaus Martha-Maria, Halle-Dölau
Halle (Saale), Germany, 06120
Asklepios Klinik Harburg
Hamburg, Germany, 21075
Thoraxklinik Heidelberg
Heidelberg, Germany, 69126
Lungenklink Hemer des Deutschen Gemeinschafts-Diakonieverbandes GmbH
Hemer, Germany, 58675
St. Vincentius-Kliniken Karlsruhe
Karlsruhe, Germany, 76137
Universitaetsklinikum Schleswig-Holstein
Lübeck, Germany, 23538
Universitätsklinikum Mainz
Mainz, Germany, 55131
Asklepios Klinikum Gauting
Muenchen-Gauting, Germany, 82131
Pius Hospital Oldenburg
Oldenburg, Germany, 26121
Schwarzwald-Baar Klinikum
Villingen-Schwenningen, Germany, 78050
IASO GENERAL Hospital of Athens
Athens, Greece, 15562
"Papageorgiou" General Hospital of Thessaloniki
Thessaloniki, Greece, 54603
"G. Papanikolaou" General Hospital of Thessaloniki
Thessaloniki, Greece, 57010
Országos Korányi TBC és Pulmonológiai Intézet
Budapest, Hungary, 1121
Semmelweis Egyetem Altalanos Orvostudomanyi KarPulmonologiai Klinika
Budapest, Hungary, 1125
Csongrad Megyei Onkormanyzat, Mellkasi Betegsegek Szakkorhaza
Deszk, Hungary, 6772
Pecsi Tudomanyegyete m klinikai kozpont, I.sz Belgyogyaszati klinika Pulmonologiai Munkacsoport
Pécs, Hungary, 7623
Fejer Megyei Szent Gyorgy Korhaz
Szekesfehervar, Hungary, 8000
Vas Megyei Markusovszky Lajos Altalanos Rehabilitacios es Gyogyfurdo Korhaz, Egyetemi Oktatokorhaz Zarkoruen Mukodo Nonprofit Reszvenytarsasag
Szombathely, Hungary, 9700
Azienda Ospedaliero Universitaria Ospedali Riuniti Umberto I
Ancona, Italy, 60020
U.O. di Oncologia Medica - Ospedale Bellaria
Bologna, Italy, 40139
Ospedale Garibaldi Nesima
Catania, Italy, 95100
Istituto Nazionale per la Ricerca e la Cura del Cancro
Genova, Italy, 16132
Azienda Ospedaliero- Universitaria di Parma
Parma, Italy, 43100
Azienda Ospedaliera San Camillo Forlanini
Roma, Italy, 00152
Korea, Republic of
Saint Vincent Hospital
Gyeonggi-Do, Korea, Republic of, 442-723
Gachon Medical School Ghil Medical Center
In Cheon, Korea, Republic of, 405-760
Seoul National University Hospital
Seoul, Korea, Republic of, 110-744
Severance Hospital, Yonsei Univ. College of Medicine
Seoul, Korea, Republic of, 120-752
Asan Medical Center
Seoul, Korea, Republic of, 138-736
SPSK Nr 4 w Lublinie
Lublin, Poland, 20-954
Mazowieckie Centrum Leczenia Chorob Pluc i Gruzlicy
Otwock, Poland, 05-400
Wielkoposkie Centrum Pulmonologii i Torakochirurgii, Oddsial Onkologii Klinicznej z Pododdzialem Dziennej Chemioterapii
Poznan, Poland, 60-569
Specjalistyczny Szpital im. prof.Alfreda Sokolowskiego
Szczecin, Poland, 70-891
Centrum Onkologii - Instytut im. Marii Skllodowskiej - Curie
Warsaw, Poland, 02-781
Katedra i Klinika Pulmonologii i Nowotworow Pluc AM
Wroclaw, Poland, 53-439
Spitalui Clinic Judetean de UrgentaOradea, Sectia de Oncologie
Oradea, Bihor, Romania, 410032
S.C. Meditech SRL
Craiova, Dolj, Romania, 200535
Institutul Oncologic Al. Trestioreanu
Bucuresti, Romania, 022328
Institutul Oncologic Al. Trestioreanu Sectia Oncologie Medicala II
Bucuresti, Romania, 022328
Institutul Oncologic I Chiricuta
Cluj-Napoca, Romania, 400015
Centrul de Oncologie Medicala
Iasi, Romania, 700106
Spitalul Clinic Judetean Sibiu
Sibiu, Romania, 550245
Russian Federation
State Healthcare Institution "Arkhangelsk Regional Clinical Oncology Dispensary"
Arkhangelsk, Russian Federation, 163045
State Healthcare InstitutionRegional Clinical Oncology Dispensary
Kemerovo, Russian Federation, 650036
State Healthcare Institution "Region Clinical Hospital # 1 n.a. professor S.V. Ochapovsky"
Krasnodar, Russian Federation, 350086
State Institution "Russian Oncology Scientific Centre n.a. N.N. Blokhin under the Russian Academy of Medical Sciences"
Moscow, Russian Federation, 115478
State Institution "Central Military Clinical Hospital n.a. academician N.N. Burdenko under the Ministry of Defense of Russia"
Moscow, Russian Federation, 105229
Saint-Petersburg State Healthcare Institution "City Clinical Oncology Dispensary"
Saint-Petersburg, Russian Federation, 198255
Federal State Institution "Petrov Scientific Research Institute of Oncology of Rosmedtechnology"
Saint-Petersburg, Russian Federation, 197758
Saint-Petersburg State Medical University n.a. ac. I.P. Pavlov, Dept. of Thoracal Oncology
Saint-Petersburg, Russian Federation, 197022
Tomsk Regional Oncology Dispensary
Tomsk, Russian Federation, 634050
State Healthcare Institution of Yaroslavl Region "Regional Clinical Oncology Hospital"
Yaroslavl, Russian Federation, 150040
ICO (Institut Catalá d´Oncología)
L` Hospitalet de Llobregat, Barcelona, Spain, 08907
Fundació Althaia
Manresa, Barcelona, Spain, 08243
Corporació Sanitaria Parc Taulí
Sabadell, Barcelona, Spain, 08208
Hospital Puerta de Hierro
Majadahonda, Madrid, Spain, 28222
Hospital Universitario la Paz
Madrid, Spain, 28046
Centro Oncologico MD Anderson International
Madrid, Spain, 28033
Hospital Universitario 12 de Octubre
Madrid, Spain, 28041
Hospital Clínico Virgen de la Victoria
Málaga, Spain, 29010
Hospital Universitario Carlos Haya
Málaga, Spain, 29010
Clinica Universitaria de Navarra
Pamplona, Spain, 31008
Hospital Marques de Valdecilla
Santander, Spain, 39008
Hospital El Tomillar (Hospital Valme)
Sevilla, Spain, 41700
Hospital Virgen de la Salud de Toledo
Toledo, Spain, 45004
Hospital General de Valencia
Valencia, Spain, 46014
Changhua Christian Hospital
Changhua, Taiwan, 500-06
Chang Gung Memorial Hospital
Kaohsiung, Taiwan, 833
Chung Shan Medical University Hospital
Taichung, Taiwan, 402
China Medical University Hospital
Taichung, Taiwan, 404
Taichung Veterans General Hospital
Taichung, Taiwan, 407
Taipei Veterans General Hospital
Taipei, Taiwan, 112
Chang Gung Memorial Hospital
Taoyuan, Taiwan, 333
United Kingdom
Birmingham Heartlands Hospital
Birmingham, United Kingdom, B9 5SS
Bristol Haematology and Oncology Centre
Bristol, United Kingdom, BS2 8ED
Ninewells Hospital
Dundee, United Kingdom, DD1 9SY
Beatson West of Scotland Cancer Centre
Glasgow, United Kingdom, G12 0YN
The Royal Surrey County Hospital NHS Trust
Guildford, United Kingdom, GU2 7XX
Leicester Royal Infirmary
Lecester, United Kingdom, LE1 5WW
St James' Institute of Oncology, Bexley Wing, St James' University Hospital
Leeds, United Kingdom, LS9 7TF
Guy`s Hospital Cancer Managements Offices
London, United Kingdom, SE1 9RT
Royal Marsden Hospital
London, United Kingdom, SW3 6JJ
Royal Marsden Hospital
Sutton, United Kingdom, SM2 5PT
Sponsors and Collaborators
OSI Pharmaceuticals
Study Director: Medical Monitor Astellas Pharma Global Development
  More Information

No publications provided

Responsible Party: Astellas Pharma Inc ( OSI Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT00373425     History of Changes
Other Study ID Numbers: OSI-774-302, 2005-001747-29
Study First Received: September 7, 2006
Last Updated: January 6, 2014
Health Authority: United States: Food and Drug Administration
Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
Austria: Federal Office for Safety in Health Care
Australia: Department of Health and Ageing Therapeutic Goods Administration
Belgium: Federal Agency for Medicinal Products and Health Products
Canada: Health Canada
Czech Republic: State Institute for Drug Control
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Federal Institute for Drugs and Medical Devices
Greece: National Organization of Medicines
Hungary: National Institute of Pharmacy
Italy: The Italian Medicines Agency
Korea: Food and Drug Administration
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Romania: Ministry of Public Health
Russia: FSI Scientific Center of Expertise of Medical Application
Spain: Agencia Española de Medicamentos y Productos Sanitarios
Taiwan: Center for Drug Evaluation
United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Astellas Pharma Inc:
Adjuvant Non-small Cell Lung Cancer
Early-stage Lung Cancer
EGFR-positive tumor
Stage IB Non-small Cell Lung Cancer
Stage II Non-small Cell Lung Cancer
Stage IIIA Non-small Cell Lung Cancer

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 16, 2014