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

NCT ID: NCT00373425

Last Updated: 2015-09-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 1252 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-09-30
• Study Completion Date: 2014-06-30

Brief Summary

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.

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.

Conditions

Non-small Cell Lung Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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.

Group Type: EXPERIMENTAL

Erlotinib

Intervention Type: DRUG

150 mg tablet

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.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo tablet

Interventions

Erlotinib

150 mg tablet

Intervention Type: DRUG

Placebo

Placebo tablet

Intervention Type: DRUG

Other Intervention Names

OSI-774; Tarceva

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

OSI Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Monitor

Role: STUDY_DIRECTOR

Astellas Pharma Global Development

Locations

University of Alabama at Birmingham

Birmingham, Alabama, United States

Arizona Cancer Center

Tucson, Arizona, United States

University of Arkansas for Medical Science

Little Rock, Arkansas, United States

Tower Cancer Research Foundation

Beverly Hills, California, United States

City of Hope Nat'l Medical Center

Duarte, California, United States

Loma Linda University Medical Center

Loma Linda, California, United States

USC/ Norris Comprehensive Cancer Center

Los Angeles, California, United States

Cedars-Sinai Medical Center

Los Angeles, California, United States

Hoag Memorial Hospital Presbyterian

Newport Beach, California, United States

Comprehensive Cancer Center at Desert Regional Medical Center

Palm Springs, California, United States

Bay Area Cancer Research Group, LLC

Pleasant Hill, California, United States

University of California, San Francisco Comprehensive Cancer Center

San Francisco, California, United States

City of Hope Medical Group (COHMG)

South Pasadena, California, United States

Rocky Mountain Cancer Center- Aurora

Aurora, Colorado, United States

University of Colorado Hospital

Aurora, Colorado, United States

Rocky Mountain Cancer Centers-Boulder

Boulder, Colorado, United States

Penrose St. Francis Health Services

Colorado Springs, Colorado, United States

Rocky Mountain Cancer Center

Colorado Springs, Colorado, United States

Rocky Mountain Cancer Center

Colorado Springs, Colorado, United States

Rocky Mountain Cancer Center-Midtown

Denver, Colorado, United States

Rocky Mountain Cancer Centers- Rose

Denver, Colorado, United States

Rocky Mountain Cancer Centers

Lakewood, Colorado, United States

Rocky Mountain Cancer Centers-Littleton

Littleton, Colorado, United States

Rocky Mountain Cancer Center-Sky Ridge

Lone Tree, Colorado, United States

Rocky Mountain Cancer Centers-Longmont

Longmont, Colorado, United States

Rocky Mountain Cancer Center-Parker

Parker, Colorado, United States

Rocky Mountain Cancer Centers

Thornton, Colorado, United States

Yale University

New Haven, Connecticut, United States

Smilow Cancer Hospital Care Center

Sharon, Connecticut, United States

Hematology Oncology, P.C.

Stamford, Connecticut, United States

Smilow Cancer Hospital Care Center

Torrington, Connecticut, United States

Florida Cancer Institute-New Hope

Hudson, Florida, United States

Cancer Specialists of North Florida

Jacksonville, Florida, United States

Cancer Specialists of North Florida

Jacksonville, Florida, United States

Watson Clinic LLP

Lakeland, Florida, United States

Advanced Medical Specialties

Miami, Florida, United States

Florida Cancer Institute- New Hope

New Port Richey, Florida, United States

Florida Cancer Specialists

Orlando, Florida, United States

Hematology Oncology Associates of the Treasure Coast

Port Saint Lucie, Florida, United States

Peachtree Hematology-Oncology Consultants, P.C.

Atlanta, Georgia, United States

Central Georgia Cancer Care, PC

Macon, Georgia, United States

Northwest Georgia Oncology Centers, PC

Marietta, Georgia, United States

Mountain States Tumor Institute

Boise, Idaho, United States

Mountain States Tumor Institute

Meridian, Idaho, United States

Kootenai Cancer Center

Post Falls, Idaho, United States

Mountain States Tumor Institute

Twin Falls, Idaho, United States

Rush University Medical Center

Chicago, Illinois, United States

University of Chicago, Section of Hematology/Oncology

Chicago, Illinois, United States

Joliet Oncology Hematology Assoc., LTD

Joliet, Illinois, United States

Loyola University Medical Center

Maywood, Illinois, United States

Indiana University Health

Carmel, Indiana, United States

Indiana University Health

Fishers, Indiana, United States

Indiana University Health

Greenfield, Indiana, United States

Indiana University Health

Indianapolis, Indiana, United States

Indiana University Health

Indianapolis, Indiana, United States

University of Kansas Medical Center

Westwood, Kansas, United States

Norton Healthcare, Inc.

Louisville, Kentucky, United States

Leonard J. Chabert Medical Center

Houma, Louisiana, United States

Cancer Care of Maine

Brewer, Maine, United States

Greater Baltimore Medical Center

Baltimore, Maryland, United States

St. Joseph Medical Center's Cancer Institute

Towson, Maryland, United States

Caritas St. Elizabeth's Medical Center

Boston, Massachusetts, United States

St. Joseph Mercy Hospital

Ann Arbor, Michigan, United States

Minnesota Oncology Hematology, P.A.

Burnsville, Minnesota, United States

Minnesota Oncology Hematology, P.A.

Edina, Minnesota, United States

Minnesota Oncology Hematology, P.A.

Maplewood, Minnesota, United States

Minnesota Oncology Hematology, P.A.

Minneapolis, Minnesota, United States

Minnesota Oncology Hematology

Saint Paul, Minnesota, United States

Minnesota Oncology Hematology, P.A.

Woodbury, Minnesota, United States

Missouri Cancer Associates

Columbia, Missouri, United States

Heartland Regional Medical Center d/b/a Heartland Clinic

Saint Joseph, Missouri, United States

St. Francis Cancer Treatment Center

Grand Island, Nebraska, United States

Nebraska Methodist Hospital

Omaha, Nebraska, United States

Comprehensive Cancer Centers of Nevada

Henderson, Nevada, United States

Comprehensive Cancer Centers of Nevada

Las Vegas, Nevada, United States

Comprehensive Cancer Centers of Nevada

Las Vegas, Nevada, United States

Comprehensive Cancer Centers of Nevada

Las Vegas, Nevada, United States

NH Oncology-Hematology PA (Co)

Concord, New Hampshire, United States

NH Oncology-Hematology PA

Hooksett, New Hampshire, United States

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, United States

Hackensack University Medical Center

Hackensack, New Jersey, United States

University of New Mexico Health Science Center

Albuquerque, New Mexico, United States

Christus St. Vincent Regional Cancer Center

Santa Fe, New Mexico, United States

Interlakes Oncology Hematology, PC

Brockport, New York, United States

Interlakes Oncology Hematology, PC

Canadaigua, New York, United States

Interlakes Oncology Hematology, PC

Geneva, New York, United States

Advanced Oncology Associates

New Rochelle, New York, United States

The New York Presbyterian-Weill Medical College of Cornell University

New York, New York, United States

Interlakes Oncology Hematology, PC

Rochester, New York, United States

Interlakes Oncology Hematology, PC

Rochester, New York, United States

Stony Brook University Medical Center

Stony Brook, New York, United States

Montefiore Medical Center

The Bronx, New York, United States

Raleigh Hematology Oncology Associates d/b/a Cancer Center of North Carolina

Cary, North Carolina, United States

Carolina Oncology Specialists PA

Hickory, North Carolina, United States

Raleigh Hematology Oncology Associates

Raleigh, North Carolina, United States

Raleigh Hematology Oncology Associates

Raleigh, North Carolina, United States

Aultman Hospital/ North Canton Medical Foundation

Canton, Ohio, United States

University Hopsitals of Cleveland

Cleveland, Ohio, United States

Hematology Oncology Consultants Inc.

Columbus, Ohio, United States

Earle A Chiles Research Institute

Portland, Oregon, United States

Northwest Cancer Specialists, PC

Portland, Oregon, United States

Northwest Cancer Specialists, PC

Portland, Oregon, United States

Northwest Cancer Specialists, PC

Portland, Oregon, United States

Northwest Cancer Specialists, PC

Tualatin, Oregon, United States

Cancer Care Associates - Medical Oncology

Bethlehem, Pennsylvania, United States

The Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, United States

Allegheny General Hospital

Pittsburgh, Pennsylvania, United States

South Carolina Oncology Assoc., PA

Columbia, South Carolina, United States

Cancer Centers of the Carolinas

Easley, South Carolina, United States

Cancer Centers of the Carolinas

Greenville, South Carolina, United States

Cancer Centers of the Carolinas

Greenville, South Carolina, United States

Cancer Centers of the Carolinas, Seneca

Seneca, South Carolina, United States

Cancer Centers of the Carolinas

Spartanburg, South Carolina, United States

Cookeville Regional Medical Center

Cookeville, Tennessee, United States

Bostin Baskin Cancer Foundation

Germantown, Tennessee, United States

Tennessee Cancer Specialists

Knoxville, Tennessee, United States

Bostin Baskin Cancer Foundation

Memphis, Tennessee, United States

Family Cancer Center Foundation, Inc.

Memphis, Tennessee, United States

West Clinic

Memphis, Tennessee, United States

Sarah Cannon Cancer Center

Nashville, Tennessee, United States

Sarah Cannon Research Institute

Nashville, Tennessee, United States

Texas Oncology, P.A. - Amarillo

Amarillo, Texas, United States

Texas Oncology Beaumont

Beaumont, Texas, United States

Texas Oncology Texas Cancer Center at Medical City

Dallas, Texas, United States

Baylor Charles A Sammons Cancer Center

Dallas, Texas, United States

Texas Oncology - Flower Mound

Flower Mound, Texas, United States

Texas Oncology, Fort Worth

Fort Worth, Texas, United States

Texas Oncology Southwest Forth Worth

Fort Worth, Texas, United States

Texas Oncology, Garland

Garland, Texas, United States

Cancer Care Centers of South Texas - HOAST

New Braunfels, Texas, United States

Texas Oncology - Paris

Paris, Texas, United States

Texas Oncology - Plano East

Plano, Texas, United States

Cancer Care Centers of South Texas-HOAST

San Antonio, Texas, United States

Texas Oncology -Tyler

Tyler, Texas, United States

Texas Oncology Cancer Care and Research Center

Waco, Texas, United States

Onc and Hem Associates of SW VA, Inc. d/b/a Blue Ridge Cancer Care

Christiansburg, Virginia, United States

Onc and Hem Associates of SW VA, Inc.

Christiansburg, Virginia, United States

Virginia Oncology Associates

Hampton, Virginia, United States

Virginia Oncology Associates

Newport News, Virginia, United States

Virginia Oncology Associates

Norfolk, Virginia, United States

Onc and Hem Associates of SW VA, Inc. d/b/a Blue Ridge Cancer Care

Roanoke, Virginia, United States

Onc and Hem Assoc of SW VA, Inc d/b/a Blue Ridge Cancer Care

Salem, Virginia, United States

Onc and Hem Associates of SW VA, Inc. d/b/a Blue Ridge Cancer Care

Wytheville, Virginia, United States

Univ. of Washington/ Seattle Cancer Care Alliance

Seattle, Washington, United States

Cancer Care Northwest

Spokane, Washington, United States

Cancer Care Northwest-North

Spokane, Washington, United States

Cancer Care Northwest-Valley

Spokane Valley, Washington, United States

Northwest Cancer Specialists, P.C.

Vancouver, Washington, United States

Northwest Cancer Specialist, P.C.

Vancouver, Washington, United States

COIR

Mendoza, Mendoza Province, Argentina

ISIS Centro Especializado De Luce S.A.

Santa Fé, Santa Fe Province, Argentina

Hospital Italiano de Buenos Aires

Buenos Aires, , Argentina

Hospital de Rehabilitación Respiratoria María Ferrer

Buenos Aires, , Argentina

Hospital Espanol de Rosario

Rosario, Santa Fe, , Argentina

Campbelltown Hospital

Campbelltown, New South Wales, Australia

Liverpool Hospital

Liverpool, New South Wales, Australia

Royal North Shore Hospital

St Leonards, New South Wales, Australia

Monash Medical Centre

East Bentleigh, Victoria, Australia

St Vincent's Hospital Melbourne

Fitzroy, Victoria, Australia

Austin Hospital

Heidelberg, Victoria, Australia

Respiratory Clinical Trials Pty., Ltd

Adelaide, , Australia

Ashford Cancer Centre

Ashford, , Australia

Universitaetsklinikum Innsbruck

Innsbruck, , Austria

Allgemeines Krankenhaus der Stadt Linz

Linz, , Austria

Landeskrankenhaus SalzburgUniversitaetsklinikum der PMUUniversitaetsklinik für Pneumologie

Salzburg, , Austria

AKH Wien

Vienna, , Austria

Krankenhaus Hietzing

Vienna, , Austria

SMZ Baumgartner Hoehe - Otto Wagner Spital

Vienna, , Austria

SMZ Baumgartner Höhe - Otto- Wagner-Spital

Vienna, , Austria

Hôpital Erasme

Brussels, , Belgium

Cliniques Universitaires Saint-Luc

Brussels, , Belgium

Le Grand Hôpital de Charleroi

Charleroi, , Belgium

Centre Hospitalier Jolimont-Lobbes

La Louvière, , Belgium

Cross Cancer Institute

Edmonton, Alberta, Canada

Cancer Center of Southeastern Ontario at Kingston General Hospital

Kingston, Ontario, Canada

Trillium Health Partners - Credit Valley Hospital

Mississauga, Ontario, Canada

Stronach Regional cancer Centre at Southlake

Newmarket, Ontario, Canada

RS MacLaughlin Durham Regional Cancer Centre

Oshawa, Ontario, Canada

Sault Area Hospital

Sault Ste. Marie, Ontario, Canada

Thunder Bay Regional Health Science Centre

Thunder Bay, Ontario, Canada

Toronto General Hospital

Toronto, Ontario, Canada

McGill Dept. of Oncology

Montreal, Quebec, Canada

Royal Victoria Hospital

Montreal, Quebec, Canada

Montreal General Hospital

Montreal, Quebec, Canada

St. Joseph's Health Centre

Toronto, , Canada

Nemocnice Ceske Budejovice, a.s.

České Budějovice, , Czechia

Fakultni nemocnice OstravaKlinika tuberkulozy a respiracnich nemoci

Ostrava-Poruba, , Czechia

FN Bulovka Klinika plincni a hrrudni chirurgie

Prague, , Czechia

CHU Larrey Service de Pneumologie, Clinique des voies respiratoires

Toulouse, Cedex 9, France

Centre d'Oncologie et de Radiothérapie du Pays Basque

Bayonne, , France

C.H.U. Morvan, Institut de Cancerologie et d'Hématologie

Brest, , France

CHU de Caen - Service de pneumologie

Caen, , France

CHU Clermont Ferrand - Hôpital Gabriel Montpied - Service de pneumologie

Clermont-Ferrand, , France

Hopital De La Croix-Rousse Service de Pneumologie

Lyon, , France

Institut Paoli-Calmettes

Marseille, , France

Hôpital de Tenon

Paris, , France

Fondation Hôpital Saint Joseph

Paris, , France

Centre Catalan d'Oncologie

Perpignan, , France

CHU - Hopital Pontchaillou - Service de pneumologie

Rennes, , France

Institut de Cancérologie de la Loire

Saint-Priest-en-Jarez, , France

Hôpital de Brabois

Vandœuvre-lès-Nancy, , France

Zentralklinik Bad Berka

Bad Berka, , Germany

HELIOS Klinikum Emil von Behring GmbH

Berlin, , Germany

Augusta-Krankenanstalt Bochum

Bochum, , Germany

Fachkrankenhaus Coswig

Coswig, , Germany

Universitaetsklinikum Essen

Essen, , Germany

Krankenhaus Nordwest

Frankfurt am Main, , Germany

Universitätsklinikum Freiburg

Freiburg im Breisgau, , Germany

Universitätsklinikum Göttingen

Göttingen, , Germany

Lungenclinic Großhansdorf

Großhansdorf, , Germany

Städtisches Krankenhaus Martha-Maria, Halle-Dölau

Halle, , Germany

Asklepios Klinik Harburg

Hamburg, , Germany

Thoraxklinik Heidelberg

Heidelberg, , Germany

Lungenklink Hemer des Deutschen Gemeinschafts-Diakonieverbandes GmbH

Hemer, , Germany

St. Vincentius-Kliniken Karlsruhe

Karlsruhe, , Germany

Universitaetsklinikum Schleswig-Holstein

Lübeck, , Germany

Universitätsklinikum Mainz

Mainz, , Germany

Asklepios Klinikum Gauting

Muenchen-Gauting, , Germany

Pius Hospital Oldenburg

Oldenburg, , Germany

Schwarzwald-Baar Klinikum

Villingen-Schwenningen, , Germany

IASO GENERAL Hospital of Athens

Athens, , Greece

"Papageorgiou" General Hospital of Thessaloniki

Thessaloniki, , Greece

"G. Papanikolaou" General Hospital of Thessaloniki

Thessaloniki, , Greece

Országos Korányi TBC és Pulmonológiai Intézet

Budapest, , Hungary

Semmelweis Egyetem Altalanos Orvostudomanyi Kar Pulmonologiai Klinika

Budapest, , Hungary

Csongrad Megyei Onkormanyzat, Mellkasi Betegsegek Szakkorhaza

Deszk, , Hungary

Pecsi Tudomany Egyete m Klinikai Kozpont, I.sz Belgyogyaszati Klinika Pulmonologiai Munkacsoport

Pécs, , Hungary

Fejer Megyei Szent Gyorgy Korhaz

Székesfehérvár, , Hungary

Vas Megyei Markusovszky Lajos Altalanos Rehabilitacios es Gyogyfurdo Korhaz, Egyetemi Oktatoko Zarkoruen Mukodo Nonprofit Reszveny Tarsasag

Szombathely, , Hungary

Azienda Ospedaliero Universitaria Ospedali Riuniti Umberto I

Ancona, , Italy

Ospedale Bellaria

Bologna, , Italy

Ospedale Garibaldi Nesima

Catania, , Italy

Istituto Nazionale per la Ricerca e la Cura del Cancro

Genova, , Italy

Azienda Ospedaliero- Universitaria di Parma

Parma, , Italy

Ospedale S. Maria della Misericordia

Perugia, , Italy

Azienda Ospedaliera San Camillo Forlanini

Roma, , Italy

Samodzielny Publiczny Szpital Kliniczny Nr 4

Lublin, , Poland

Mazowieckie Centrum Leczenia Chorob Pluc i Gruzlicy

Otwock, , Poland

Wielkoposkie Centrum Pulmonologii i Torakochirurgii, Oddzial Onkologii Klinicznej z Pododdzialem Dziennej Chemioterapii

Poznan, , Poland

Specjalistyczny Szpital im. prof.Alfreda Sokolowskiego

Szczecin, , Poland

Centrum Onkologii - Instytut im. Marii Skllodowskiej - Curie

Warsaw, , Poland

Dolnoslaskie Centrum Chorob Pluc we Wroclawiu, Katedra i Klinika Pulmonologii i Nowotworow Pluc Akademii Medycznej

Wroclaw, , Poland

Spitalui Clinic Judetean de Urgenta, Sectia de Oncologie

Oradea, Bihor County, Romania

Oncoloab SRL

Craiova, Dolj, Romania

Centrul de Oncologie Medicala

Iași, Iaşi, Romania

Institutul Oncologic Al. Trestioreanu Sectia Oncologie Medicala II

Bucharest, , Romania

Institutul Oncologic Al. Trestioreanu

Bucharest, , Romania

Institutul Oncologic Prof. Dr. Ion Chiricuta

Cluj-Napoca, , Romania

Spitalul Clinic Judetean Sibiu

Sibiu, , Romania

State Healthcare Institution "Arkhangelsk Regional Clinical Oncology Dispensary"

Arkhangelsk, , Russia

State Healthcare Institution "Regional Clinical Oncology Dispensary"

Kemerovo, , Russia

State Healthcare Institution "Region Clinical Hospital # 1 n.a. professor S.V. Ochapovsky"

Krasnodar, , Russia

State Institution "Central Military Clinical Hospital n.a. academician N.N. Burdenko under the Ministry of Defense of Russia"

Moscow, , Russia

Institution of the RAMS "Russian Oncology Scientific Centre n.a. N.N. Blokhin under the Russian Academy of Medical Sciences"

Moscow, , Russia

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, , Russia

Federal State Institution "Petrov Scientific Research Institute of Oncology of Rosmedtechnology"

Saint Petersburg, , Russia

Saint-Petersburg State Healthcare Institution "City Clinical Oncology Dispensary"

Saint Petersburg, , Russia

Regional State Budget Healthcare Instiution"Tomsk Regional Oncology Dispensary"

Tomsk, , Russia

State Healthcare Institution of Yaroslavl Region "Regional Clinical Oncology Hospital"

Yaroslavl, , Russia

Saint Vincent's Hospital

Gyeonggi-do, , South Korea

Gachon Medical School Ghil Medical Center

Incheon, , South Korea

Seoul National University Hospital

Seoul, , South Korea

Severance Hospital, Yonsei Univ. College of Medicine

Seoul, , South Korea

Asan Medical Center

Seoul, , South Korea

ICO (Institut Catalá d´Oncología)

L'Hospitalet de Llobregat, Barcelona, Spain

Fundació Althaia

Manresa, Barcelona, Spain

Corporació Sanitaria Parc Taulí

Sabadell, Barcelona, Spain

Hospital Puerta de Hierro Majadahonda

Majadahonda, Madrid, Spain

Hospital General Universitario de Valencia

Valencia, Valencia, Spain

Hospital Oncologico MD Anderson

Madrid, , Spain

Hospital Universitario 12 de Octubre

Madrid, , Spain

Hospital Universitario La Paz

Madrid, , Spain

Hospital Carlos Haya

Málaga, , Spain

Hospital Clínico Virgen de la Victoria

Málaga, , Spain

Clinica Universitaria de Navarra

Pamplona, , Spain

Hospital Universitario Marques de Valdecilla

Santander, , Spain

Hospital Universitario de Valme

Seville, , Spain

Hospital Virgen de la Salud de Toledo

Toledo, , Spain

Changhua Christian Hospital

Changhua, , Taiwan

Chang Gung Medical Foundation

Kaohsiung City, , Taiwan

Chung Shan Medical University Hospital

Taichung, , Taiwan

China Medical University Hospital

Taichung, , Taiwan

Taichung Veterans General Hospital

Taichung, , Taiwan

Taipei Veterans General Hospital

Taipei, , Taiwan

Chang Gung Memorial Hospital

Taoyuan District, , Taiwan

Birmingham Heartlands Hospital

Birmingham, , United Kingdom

Bristol Haematology and Oncology Centre

Bristol, , United Kingdom

Ninewells Hospital

Dundee, , United Kingdom

Beatson West of Scotland Cancer Centre

Glasgow, , United Kingdom

The Royal Surrey County Hospital NHS Trust

Guildford, , United Kingdom

Leicester Royal Infirmary

Lecester, , United Kingdom

St James' Institute of Oncology, Bexley Wing, St James' University Hospital

Leeds, , United Kingdom

Guy's Hospital

London, , United Kingdom

Royal Marsden Hospital

London, , United Kingdom

Royal Marsden Hospital

Sutton, , United Kingdom

Countries

United States; Argentina; Australia; Austria; Belgium; Canada; Czechia; France; Germany; Greece; Hungary; Italy; Poland; Romania; Russia; South Korea; Spain; Taiwan; United Kingdom

References

Kelly K, Altorki NK, Eberhardt WE, O'Brien ME, Spigel DR, Crino L, Tsai CM, Kim JH, Cho EK, Hoffman PC, Orlov SV, Serwatowski P, Wang J, Foley MA, Horan JD, Shepherd FA. Adjuvant Erlotinib Versus Placebo in Patients With Stage IB-IIIA Non-Small-Cell Lung Cancer (RADIANT): A Randomized, Double-Blind, Phase III Trial. J Clin Oncol. 2015 Dec 1;33(34):4007-14. doi: 10.1200/JCO.2015.61.8918. Epub 2015 Aug 31.

Reference Type: DERIVED

PMID: 26324372 (View on PubMed)

Related Links

https://www.astellasclinicalstudyresults.com/study.aspx?ID=OSI-774-302

Link to results on Astellas Clinical Study Results website

Other Identifiers

2005-001747-29

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

OSI-774-302

Identifier Type: -

Identifier Source: org_study_id