A Study of Erlotinib (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.
Sponsor:
Information provided by (Responsible Party):
Astellas Pharma Inc ( OSI Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT00373425
First received: September 7, 2006
Last updated: May 9, 2014
Last verified: May 2014
  Purpose

This is a study to evaluate the effectiveness of erlotinib compared with a 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: Erlotinib
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 5 years and yearly thereafter (maximum time on follow-up was 64 months). ] [ Designated as safety issue: No ]
    DFS is the time from the date of randomization until the first day non-small cell lung cancer (NSCLC) relapse is documented by radiological exam and/or biopsy, or until death in the absence of relapse. After randomization, NSCLC relapse was based on radiological evidence or biopsy, as determined by the investigator. Participants without a DFS event were censored on the last adequate radiological assessment date.


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 (maximum time on follow-up was 64 months) ] [ Designated as safety issue: No ]
    Overall survival was defined as the time from the date of randomization until the documented date of death. Participants who were still alive were censored on the last day they were known to be alive.

  • Disease-free Survival in Participants 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 (maximum time on follow-up was 64 months). ] [ Designated as safety issue: No ]
    Disease-free survival (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. After randomization, NSCLC relapse was based on radiological evidence or biopsy, as determined by the investigator. Participants without a DFS event were censored on the last adequate radiological assessment date. Activating EGFR mutation-positive is defined as exon 19 deletion or exon 21 L858R (or both) detected.

  • Overall Survival in Participants 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 (maximum time on follow-up was 64 months) ] [ Designated as safety issue: No ]

    Overall survival is defined as the time from the date of randomization until the documented date of death. Participants who were still alive were censored on the last day they were known to be alive.

    Activating EGFR mutation-positive is defined as exon 19 deletion or exon 21 L858R (or both) detected.


  • Number of Participants With Adverse Events (AEs) [ Time Frame: From the date of first dose of study drug until 30 days after the last dose. The median time on treatment was 11.9 months for erlotinib and 21.9 months for placebo. ] [ Designated as safety issue: No ]

    An AE was defined as any untoward medical occurrence in a study participant and did not necessarily have a causal relationship with study treatment.

    An AE was considered serious if it resulted in death, a life-threatening situation, inpatient hospitalization or prolongation of an existing hospitalization, persistent or significant disability/incapacity, congenital anomaly/birth defect in the offspring of a patient who received study drug or other important medical events.

    A drug-related AE was any AE with at least a possible relationship to study treatment as assessed by the investigator. Severity was graded by the investigator according to the National Cancer Institute Common Terminology Criteria for Adverse Events, v3.0, where Grade 1=Mild AE; Grade=2 Moderate AE; Grade 3=Severe AE; Grade 4=Life-threatening or disabling; Grade 5=Death related to AE.



Enrollment: 1252
Study Start Date: September 2006
Estimated Study Completion Date: June 2014
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Erlotinib
Participants received 150 mg/day erlotinib orally for 2 years or until relapse, death, participant request or investigator decision to discontinue study drug, or intolerable toxicity.
Drug: Erlotinib
150 mg tablet
Other Names:
  • OSI-774
  • Tarceva
Placebo Comparator: Placebo
Participants received matching placebo tablets orally for 2 years or until relapse, death, participant request or investigator decision to discontinue study drug, or intolerable toxicity.
Drug: Placebo
Placebo tablet

Detailed Description:

After the initiation of the study, the sponsor became aware of an error in the drug dispensing module of the interactive voice response such that most patients who were randomized prior to 07 November 2007 were dispensed the incorrect study drug at least once. Since the integrity of the data from these patients was seriously compromised, these patients were considered unevaluable for the protocol-specified analyses. These participants are referred to as the breached protocol cohort (BPC) and those still on study treatment at the time of the breach were offered the option of receiving open-label erlotinib for up to 2 years (including posttreatment and long-term follow-up assessments), not receiving open-label erlotinib but remaining in the study for posttreatment and long-term follow-up assessment, or withdrawing consent from treatment and further assessments. Participants who had discontinued study treatment prior to the breach were not offered open-label erlotinib and remained in long-term follow-up. Data from the BPC participants were analyzed separately and were not included in the assessments of primary or secondary endpoints in the randomized cohort and were not considered part of the primary analyses.The sample size for the randomized cohort was not changed due to the BPC and the data from RC and BPC were analyzed separately.

  Eligibility

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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00373425

  Hide Study Locations
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
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
Hoag Memorial Hospital Presbyterian
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
University of Colorado Hospital
Aurora, Colorado, United States, 80045
Rocky Mountain Cancer Centers-Boulder
Boulder, Colorado, United States, 80303
Rocky Mountain Cancer Center
Colorado Springs, Colorado, United States, 80907
Rocky Mountain Cancer Center
Colorado Springs, Colorado, United States, 80909
Penrose St. Francis Health Services
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
Thornton, Colorado, United States, 80260
United States, Connecticut
Yale University
New Haven, Connecticut, United States, 06520
Smilow Cancer Hospital Care Center
Sharon, Connecticut, United States, 06069
Hematology Oncology, P.C.
Stamford, Connecticut, United States, 06902
Smilow Cancer Hospital Care Center
Torrington, Connecticut, United States, 06790
United States, Florida
Florida Cancer Institute-New Hope
Hudson, Florida, United States, 34667
Cancer Specialists of North Florida
Jacksonville, Florida, United States, 32216
Cancer Specialists of North Florida
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
Florida Cancer Specialists
Orlando, Florida, United States, 32806
Hematology Oncology Associates of the Treasure Coast
Port St. Lucie, Florida, United States, 34952
United States, Georgia
Peachtree Hematology-Oncology Consultants, P.C.
Atlanta, Georgia, United States, 30318
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
Meridian, Idaho, United States, 83642
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
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
Indiana University Health
Carmel, Indiana, United States, 46032
Indiana University Health
Fishers, Indiana, United States, 46037
Indiana University Health
Greenfield, Indiana, United States, 46140
Indiana University Health
Indianapolis, Indiana, United States, 46227
Indiana University Health
Indianapolis, Indiana, United States, 46219
United States, Kansas
University of Kansas Medical Center
Westwood, Kansas, United States, 66205
United States, Kentucky
Norton Healthcare, Inc.
Louisville, Kentucky, United States, 40202
United States, Louisiana
Leonard J. Chabert Medical Center
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
Heartland Regional Medical Center d/b/a Heartland Clinic
St. Joseph, Missouri, United States, 64507
United States, Nebraska
St. Francis Cancer Treatment 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 Health Science Center
Albuquerque, New Mexico, United States, 87131
Christus St. Vincent Regional Cancer 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
Stony Brook University Medical Center
Stony Brook, New York, United States, 11794
United States, North Carolina
Raleigh Hematology Oncology Associates d/b/a Cancer Center of North Carolina
Cary, North Carolina, United States, 27511
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 - Medical Oncology
Bethlehem, Pennsylvania, United States, 18015
The Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Allegheny General Hospital
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
Cookeville Regional Medical Center
Cookeville, Tennessee, United States, 38501
Bostin Baskin Cancer Foundation
Germantown, Tennessee, United States, 38138
Tennessee Cancer Specialists
Knoxville, Tennessee, United States, 37909
West Clinic
Memphis, Tennessee, United States, 38120
Family Cancer Center Foundation, Inc.
Memphis, Tennessee, United States, 38119
Bostin Baskin Cancer Foundation
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
Baylor Charles A Sammons Cancer Center
Dallas, Texas, United States, 75246
Texas Oncology Texas Cancer Center at Medical City
Dallas, Texas, United States, 75230-2510
Texas Oncology - Flower Mound
Flower Mound, Texas, United States, 75028
Texas Oncology Southwest Forth Worth
Fort Worth, Texas, United States, 76132
Texas Oncology, Fort Worth
Ft. Worth, Texas, United States, 76104
Texas Oncology, Garland
Garland, Texas, United States, 75042-5788
Cancer Care Centers of South Texas - HOAST
New Braunfels, Texas, United States, 78131
Texas Oncology - Paris
Paris, Texas, United States, 75460-5004
Texas Oncology - Plano East
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 Research Center
Waco, Texas, United States, 76712
United States, Virginia
Onc and Hem Associates of SW VA, Inc. d/b/a Blue Ridge Cancer Care
Christiansburg, Virginia, United States, 24073
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. d/b/a Blue Ridge Cancer Care
Roanoke, Virginia, United States, 24014
Onc and Hem Assoc of SW VA, Inc d/b/a Blue Ridge Cancer Care
Salem, Virginia, United States, 24153
Onc and Hem Associates of SW VA, Inc. d/b/a Blue Ridge Cancer Care
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, P.C.
Vancouver, Washington, United States, 98684
Northwest Cancer Specialist, P.C.
Vancouver, Washington, United States, 98686
Argentina
Hospital Italiano de Buenos Aires
Buenos Aires, Argentina, C1181ACH
Hospital de Rehabilitación Respiratoria María Ferrer
Buenos Aires, Argentina, C1272AAA
COIR
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 Hospital
Heidelberg, Victoria, Australia, 3084
Australia
Respiratory Clinical Trials Pty., Ltd
Adelaide, Australia, 5067
Ashford Cancer Centre
Ashford, Australia, SA 5037
Austria
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
Belgium
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
Trillium Health Partners - 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
McGill Dept. of Oncology
Montreal, Quebec, Canada, H2W 1S6
Montreal General Hospital
Montreal, Quebec, Canada, H3G 1A4
Royal Victoria Hospital
Montreal, Quebec, Canada, H3A 1A1
Canada
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
France
CHU Larrey Service de Pneumologie, Clinique des voies 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 de Tenon
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
Germany
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
Lungenclinic 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
Greece
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
Hungary
Országos Korányi TBC és Pulmonológiai Intézet
Budapest, Hungary, 1121
Semmelweis Egyetem Altalanos Orvostudomanyi Kar Pulmonologiai Klinika
Budapest, Hungary, 1125
Csongrad Megyei Onkormanyzat, Mellkasi Betegsegek Szakkorhaza
Deszk, Hungary, 6772
Pecsi Tudomany Egyete 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 Oktatoko Zarkoruen Mukodo Nonprofit Reszveny Tarsasag
Szombathely, Hungary, 9700
Italy
Azienda Ospedaliero Universitaria Ospedali Riuniti Umberto I
Ancona, Italy, 60020
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
Ospedale S. Maria della Misericordia
Perugia, Italy, 06132
Azienda Ospedaliera San Camillo Forlanini
Roma, Italy, 00152
Korea, Republic of
Saint Vincent's Hospital
Gyeonggi-Do, Korea, Republic of, 442-723
Gachon Medical School Ghil Medical Center
Incheon, 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
Poland
Samodzielny Publiczny Szpital Kliniczny Nr 4
Lublin, Poland, 20-954
Mazowieckie Centrum Leczenia Chorob Pluc i Gruzlicy
Otwock, Poland, 05-400
Wielkoposkie Centrum Pulmonologii i Torakochirurgii, Oddzial 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
Dolnoslaskie Centrum Chorob Pluc we Wroclawiu, Katedra i Klinika Pulmonologii i Nowotworow Pluc Akademii Medycznej
Wroclaw, Poland, 53-439
Romania
Spitalui Clinic Judetean de Urgenta, Sectia de Oncologie
Oradea, Bihor, Romania, 410032
Oncoloab 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 Prof. Dr. Ion 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 Institution "Regional Clinical Oncology Dispensary"
Kemerovo, Russian Federation, 650036
State Healthcare Institution "Region Clinical Hospital # 1 n.a. professor S.V. Ochapovsky"
Krasnodar, Russian Federation, 350086
Institution of the RAMS "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
State Educational Institution of Higher Professional Education "Saint-Petersburg State Medical University n.a. ac. I.P. Pavlov of the Ministry of Healthcare and Social Development of the Russian Federation"
Saint-Petersburg, Russian Federation, 197022
Regional State Budget Healthcare Instiution"Tomsk Regional Oncology Dispensary"
Tomsk, Russian Federation, 634050
State Healthcare Institution of Yaroslavl Region "Regional Clinical Oncology Hospital"
Yaroslavl, Russian Federation, 150040
Spain
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
Majadahonda, Madrid, Spain, 28222
Hospital Universitario La Paz
Madrid, Spain, 28046
Hospital Oncologico MD Anderson
Madrid, Spain, 28033
Hospital Universitario 12 de Octubre
Madrid, Spain, 28041
Hospital Clínico Virgen de la Victoria
Málaga, Spain, 29010
Hospital Carlos Haya
Málaga, Spain, 29010
Clinica Universitaria de Navarra
Pamplona, Spain, 31008
Hospital Universitario Marques de Valdecilla
Santander, Spain, 39008
Hospital Universitario de Valme
Sevilla, Spain, 41700
Hospital Virgen de la Salud de Toledo
Toledo, Spain, 45004
Hospital General Universitario de Valencia
Valencia, Spain, 46014
Taiwan
Changhua Christian Hospital
Changhua, Taiwan, 500-06
Chang Gung Medical Foundation
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
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
Investigators
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
Results First Received: April 2, 2014
Last Updated: May 9, 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: Agence Nationale de Sécurité du Médicament et des produits de santé
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: National Medicines Agency
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
Tarceva
Early-stage Lung Cancer
Adjuvant
RADIANT
NSCLC
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
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Erlotinib
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 20, 2014