AzTrials
AzTrials

Non-small Cell Lung CancerPhase 3RADIANTNCT00373425

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

A Phase 3 study testing Erlotinib in people with Non-small Cell Lung Cancer, run by OSI Pharmaceuticals at 295 sites in 19 countries.

Completed

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

Official record
Search all trials

Trial summary

This is a 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Non-small Cell Lung Cancer
What is being tested?
Erlotinib
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
1,252 participants
Where
295 sitesin 19 countries
Study dates
Sep 2006to Jun 2014
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

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

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

Who may be able to join

  • 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

Who cannot join

  • 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.

Trial locations and contacts

295 sites in 19 countries.

295 sites in 19 countries

United States149 sites

  • University of New Mexico Health Science Center

    Albuquerque, New Mexico, 87131

  • Texas Oncology, P.A. - Amarillo

    Amarillo, Texas, 79106

  • St. Joseph Mercy Hospital

    Ann Arbor, Michigan, 48106

  • Peachtree Hematology-Oncology Consultants, P.C.

    Atlanta, Georgia, 30318

  • Rocky Mountain Cancer Center- Aurora

    Aurora, Colorado, 80012

  • University of Colorado Hospital

    Aurora, Colorado, 80045

  • Greater Baltimore Medical Center

    Baltimore, Maryland, 21204

  • Texas Oncology Beaumont

    Beaumont, Texas, 77702-1449

  • Cancer Care Associates - Medical Oncology

    Bethlehem, Pennsylvania, 18015

  • Tower Cancer Research Foundation

    Beverly Hills, California, 90211

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35294

  • Mountain States Tumor Institute

    Boise, Idaho, 83712

  • Caritas St. Elizabeth's Medical Center

    Boston, Massachusetts, 02135

  • Rocky Mountain Cancer Centers-Boulder

    Boulder, Colorado, 80303

  • Cancer Care of Maine

    Brewer, Maine, 04412

  • Interlakes Oncology Hematology, PC

    Brockport, New York, 14420

  • Minnesota Oncology Hematology, P.A.

    Burnsville, Minnesota, 55337

  • Interlakes Oncology Hematology, PC

    Canadaigua, New York, 14424

  • Aultman Hospital/ North Canton Medical Foundation

    Canton, Ohio, 44710

  • Indiana University Health

    Carmel, Indiana, 46032

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

    Cary, North Carolina, 27511

  • Rush University Medical Center

    Chicago, Illinois, 60612

  • University of Chicago, Section of Hematology/Oncology

    Chicago, Illinois, 60637

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

    Christiansburg, Virginia, 24073

  • Onc and Hem Associates of SW VA, Inc.

    Christiansburg, Virginia, 24073

  • University Hopsitals of Cleveland

    Cleveland, Ohio, 44106

  • Penrose St. Francis Health Services

    Colorado Springs, Colorado, 80907

  • Rocky Mountain Cancer Center

    Colorado Springs, Colorado, 80907

  • Rocky Mountain Cancer Center

    Colorado Springs, Colorado, 80909

  • Missouri Cancer Associates

    Columbia, Missouri, 65201

  • South Carolina Oncology Assoc., PA

    Columbia, South Carolina, 29210

  • Hematology Oncology Consultants Inc.

    Columbus, Ohio, 43228

  • NH Oncology-Hematology PA (Co)

    Concord, New Hampshire, 03301

  • Cookeville Regional Medical Center

    Cookeville, Tennessee, 38501

  • Texas Oncology Texas Cancer Center at Medical City

    Dallas, Texas, 75230-2510

  • Baylor Charles A Sammons Cancer Center

    Dallas, Texas, 75246

  • Rocky Mountain Cancer Center-Midtown

    Denver, Colorado, 80218

  • Rocky Mountain Cancer Centers- Rose

    Denver, Colorado, 80220

  • City of Hope Nat'l Medical Center

    Duarte, California, 91010

  • Cancer Centers of the Carolinas

    Easley, South Carolina, 29640

  • Minnesota Oncology Hematology, P.A.

    Edina, Minnesota, 55435-2150

  • Indiana University Health

    Fishers, Indiana, 46037

  • Texas Oncology - Flower Mound

    Flower Mound, Texas, 75028

  • Texas Oncology, Fort Worth

    Fort Worth, Texas, 76104

  • Texas Oncology Southwest Forth Worth

    Fort Worth, Texas, 76132

  • Texas Oncology, Garland

    Garland, Texas, 75042-5788

  • Interlakes Oncology Hematology, PC

    Geneva, New York, 14456

  • Bostin Baskin Cancer Foundation

    Germantown, Tennessee, 38138

  • St. Francis Cancer Treatment Center

    Grand Island, Nebraska, 68803

  • Indiana University Health

    Greenfield, Indiana, 46140

  • Cancer Centers of the Carolinas

    Greenville, South Carolina, 29605

  • Cancer Centers of the Carolinas

    Greenville, South Carolina, 29615

  • Hackensack University Medical Center

    Hackensack, New Jersey, 07601

  • Virginia Oncology Associates

    Hampton, Virginia, 23666

  • Comprehensive Cancer Centers of Nevada

    Henderson, Nevada, 89052

  • Carolina Oncology Specialists PA

    Hickory, North Carolina, 28602

  • NH Oncology-Hematology PA

    Hooksett, New Hampshire, 03106

  • Leonard J. Chabert Medical Center

    Houma, Louisiana, 70363

  • Florida Cancer Institute-New Hope

    Hudson, Florida, 34667

  • Indiana University Health

    Indianapolis, Indiana, 46219

  • Indiana University Health

    Indianapolis, Indiana, 46227

  • Cancer Specialists of North Florida

    Jacksonville, Florida, 32204

  • Cancer Specialists of North Florida

    Jacksonville, Florida, 32216

  • Joliet Oncology Hematology Assoc., LTD

    Joliet, Illinois, 60435

  • Tennessee Cancer Specialists

    Knoxville, Tennessee, 37909

  • Watson Clinic LLP

    Lakeland, Florida, 33805

  • Rocky Mountain Cancer Centers

    Lakewood, Colorado, 80228

  • Comprehensive Cancer Centers of Nevada

    Las Vegas, Nevada, 89128

  • Comprehensive Cancer Centers of Nevada

    Las Vegas, Nevada, 89148

  • Comprehensive Cancer Centers of Nevada

    Las Vegas, Nevada, 89169

  • Dartmouth-Hitchcock Medical Center

    Lebanon, New Hampshire, 03756

  • University of Arkansas for Medical Science

    Little Rock, Arkansas, 72205

  • Rocky Mountain Cancer Centers-Littleton

    Littleton, Colorado, 80120-4413

  • Loma Linda University Medical Center

    Loma Linda, California, 92354

  • Rocky Mountain Cancer Center-Sky Ridge

    Lone Tree, Colorado, 80124

  • Rocky Mountain Cancer Centers-Longmont

    Longmont, Colorado, 80501

  • USC/ Norris Comprehensive Cancer Center

    Los Angeles, California, 90033

  • Cedars-Sinai Medical Center

    Los Angeles, California, 90048

  • Norton Healthcare, Inc.

    Louisville, Kentucky, 40202

  • Central Georgia Cancer Care, PC

    Macon, Georgia, 31201

  • Minnesota Oncology Hematology, P.A.

    Maplewood, Minnesota, 55109

  • Northwest Georgia Oncology Centers, PC

    Marietta, Georgia, 30060

  • Loyola University Medical Center

    Maywood, Illinois, 60153

  • Bostin Baskin Cancer Foundation

    Memphis, Tennessee, 38104

  • Family Cancer Center Foundation, Inc.

    Memphis, Tennessee, 38119

  • West Clinic

    Memphis, Tennessee, 38120

  • Mountain States Tumor Institute

    Meridian, Idaho, 83642

  • Advanced Medical Specialties

    Miami, Florida, 33176

  • Minnesota Oncology Hematology, P.A.

    Minneapolis, Minnesota, 55404

  • Sarah Cannon Cancer Center

    Nashville, Tennessee, 37203

  • Sarah Cannon Research Institute

    Nashville, Tennessee, 37203

  • Cancer Care Centers of South Texas - HOAST

    New Braunfels, Texas, 78131

  • Yale University

    New Haven, Connecticut, 06520

  • Florida Cancer Institute- New Hope

    New Port Richey, Florida, 34655

  • Advanced Oncology Associates

    New Rochelle, New York, 10801

  • The New York Presbyterian-Weill Medical College of Cornell University

    New York, New York, 10065

  • Hoag Memorial Hospital Presbyterian

    Newport Beach, California, 92658

  • Virginia Oncology Associates

    Newport News, Virginia, 23606

  • Virginia Oncology Associates

    Norfolk, Virginia, 23502

  • Nebraska Methodist Hospital

    Omaha, Nebraska, 68114

  • Florida Cancer Specialists

    Orlando, Florida, 32806

  • Comprehensive Cancer Center at Desert Regional Medical Center

    Palm Springs, California, 92262

  • Texas Oncology - Paris

    Paris, Texas, 75460-5004

  • Rocky Mountain Cancer Center-Parker

    Parker, Colorado, 80138

  • The Hospital of the University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

  • Allegheny General Hospital

    Pittsburgh, Pennsylvania, 15212

  • Texas Oncology - Plano East

    Plano, Texas, 75075-7787

  • Bay Area Cancer Research Group, LLC

    Pleasant Hill, California, 94523

  • Hematology Oncology Associates of the Treasure Coast

    Port Saint Lucie, Florida, 34952

  • Earle A Chiles Research Institute

    Portland, Oregon, 97213

  • Northwest Cancer Specialists, PC

    Portland, Oregon, 97213

  • Northwest Cancer Specialists, PC

    Portland, Oregon, 97225

  • Northwest Cancer Specialists, PC

    Portland, Oregon, 97227

  • Kootenai Cancer Center

    Post Falls, Idaho, 83854

  • Raleigh Hematology Oncology Associates

    Raleigh, North Carolina, 27607

  • Raleigh Hematology Oncology Associates

    Raleigh, North Carolina, 27609

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

    Roanoke, Virginia, 24014

  • Interlakes Oncology Hematology, PC

    Rochester, New York, 14623

  • Interlakes Oncology Hematology, PC

    Rochester, New York, 14626

  • Heartland Regional Medical Center d/b/a Heartland Clinic

    Saint Joseph, Missouri, 64507

  • Minnesota Oncology Hematology

    Saint Paul, Minnesota, 55102-2389

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

    Salem, Virginia, 24153

  • Cancer Care Centers of South Texas-HOAST

    San Antonio, Texas, 78229

  • University of California, San Francisco Comprehensive Cancer Center

    San Francisco, California, 94143-1770

  • Christus St. Vincent Regional Cancer Center

    Santa Fe, New Mexico, 87505

  • Univ. of Washington/ Seattle Cancer Care Alliance

    Seattle, Washington, 98109

  • Cancer Centers of the Carolinas, Seneca

    Seneca, South Carolina, 29672

  • Smilow Cancer Hospital Care Center

    Sharon, Connecticut, 06069

  • City of Hope Medical Group (COHMG)

    South Pasadena, California, 91030

  • Cancer Centers of the Carolinas

    Spartanburg, South Carolina, 29307

  • Cancer Care Northwest

    Spokane, Washington, 99202

  • Cancer Care Northwest-North

    Spokane, Washington, 99218

  • Cancer Care Northwest-Valley

    Spokane Valley, Washington, 99216

  • Hematology Oncology, P.C.

    Stamford, Connecticut, 06902

  • Stony Brook University Medical Center

    Stony Brook, New York, 11794

  • Montefiore Medical Center

    The Bronx, New York, 10467

  • Rocky Mountain Cancer Centers

    Thornton, Colorado, 80260

  • Smilow Cancer Hospital Care Center

    Torrington, Connecticut, 06790

  • St. Joseph Medical Center's Cancer Institute

    Towson, Maryland, 21204

  • Northwest Cancer Specialists, PC

    Tualatin, Oregon, 97062

  • Arizona Cancer Center

    Tucson, Arizona, 85724

  • Mountain States Tumor Institute

    Twin Falls, Idaho, 83301

  • Texas Oncology -Tyler

    Tyler, Texas, 75702

  • Northwest Cancer Specialists, P.C.

    Vancouver, Washington, 98684

  • Northwest Cancer Specialist, P.C.

    Vancouver, Washington, 98686

  • Texas Oncology Cancer Care and Research Center

    Waco, Texas, 76712

  • University of Kansas Medical Center

    Westwood, Kansas, 66205

  • Minnesota Oncology Hematology, P.A.

    Woodbury, Minnesota, 55125

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

    Wytheville, Virginia, 24382

Other trials in United States

Germany19 sites

  • Zentralklinik Bad Berka

    Bad Berka, 99437

  • HELIOS Klinikum Emil von Behring GmbH

    Berlin, 14165

  • Augusta-Krankenanstalt Bochum

    Bochum, 44791

  • Fachkrankenhaus Coswig

    Coswig, 01640

  • Universitaetsklinikum Essen

    Essen, 45122

  • Krankenhaus Nordwest

    Frankfurt am Main, 60488

  • Universitätsklinikum Freiburg

    Freiburg im Breisgau, 79106

  • Universitätsklinikum Göttingen

    Göttingen, 37075

  • Lungenclinic Großhansdorf

    Großhansdorf, 22927

  • Städtisches Krankenhaus Martha-Maria, Halle-Dölau

    Halle, 06120

  • Asklepios Klinik Harburg

    Hamburg, 21075

  • Thoraxklinik Heidelberg

    Heidelberg, 69126

  • Lungenklink Hemer des Deutschen Gemeinschafts-Diakonieverbandes GmbH

    Hemer, 58675

  • St. Vincentius-Kliniken Karlsruhe

    Karlsruhe, 76137

  • Universitaetsklinikum Schleswig-Holstein

    Lübeck, 23538

  • Universitätsklinikum Mainz

    Mainz, 55131

  • Asklepios Klinikum Gauting

    Muenchen-Gauting, 82131

  • Pius Hospital Oldenburg

    Oldenburg, 26121

  • Schwarzwald-Baar Klinikum

    Villingen-Schwenningen, 78050

Other trials in Germany

Spain14 sites

  • ICO (Institut Catalá d´Oncología)

    L'Hospitalet de Llobregat, Barcelona, 08907

  • Hospital Oncologico MD Anderson

    Madrid, 28033

  • Hospital Universitario 12 de Octubre

    Madrid, 28041

  • Hospital Universitario La Paz

    Madrid, 28046

  • Hospital Puerta de Hierro Majadahonda

    Majadahonda, Madrid, 28222

  • Hospital Carlos Haya

    Málaga, 29010

  • Hospital Clínico Virgen de la Victoria

    Málaga, 29010

  • Fundació Althaia

    Manresa, Barcelona, 08243

  • Clinica Universitaria de Navarra

    Pamplona, 31008

  • Corporació Sanitaria Parc Taulí

    Sabadell, Barcelona, 08208

  • Hospital Universitario Marques de Valdecilla

    Santander, 39008

  • Hospital Universitario de Valme

    Seville, 41700

  • Hospital Virgen de la Salud de Toledo

    Toledo, 45004

  • Hospital General Universitario de Valencia

    Valencia, Valencia, 46014

Other trials in Spain

France13 sites

  • Centre d'Oncologie et de Radiothérapie du Pays Basque

    Bayonne, 64100

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

    Brest, 29609

  • CHU de Caen - Service de pneumologie

    Caen, 14033

  • CHU Clermont Ferrand - Hôpital Gabriel Montpied - Service de pneumologie

    Clermont-Ferrand, 63003

  • Hopital De La Croix-Rousse Service de Pneumologie

    Lyon, 69317

  • Institut Paoli-Calmettes

    Marseille, 13273

  • Hôpital de Tenon

    Paris, 75012

  • Fondation Hôpital Saint Joseph

    Paris, 75014

  • Centre Catalan d'Oncologie

    Perpignan, 66000

  • CHU - Hopital Pontchaillou - Service de pneumologie

    Rennes, 35033

  • Institut de Cancérologie de la Loire

    Saint-Priest-en-Jarez, 42271

  • CHU Larrey Service de Pneumologie, Clinique des voies respiratoires

    Toulouse, Cedex 9, 31059

  • Hôpital de Brabois

    Vandœuvre-lès-Nancy, 54511

Other trials in France

Canada12 sites

  • Cross Cancer Institute

    Edmonton, Alberta, T6G 1Z2

  • Cancer Center of Southeastern Ontario at Kingston General Hospital

    Kingston, Ontario, K7L 5P9

  • Trillium Health Partners - Credit Valley Hospital

    Mississauga, Ontario, L5M 2N1

  • McGill Dept. of Oncology

    Montreal, Quebec, H2W 1S6

  • Royal Victoria Hospital

    Montreal, Quebec, H3A 1A1

  • Montreal General Hospital

    Montreal, Quebec, H3G 1A4

  • Stronach Regional cancer Centre at Southlake

    Newmarket, Ontario, L3Y 2P9

  • RS MacLaughlin Durham Regional Cancer Centre

    Oshawa, Ontario, L1G 2B9

  • Sault Area Hospital

    Sault Ste. Marie, Ontario, P6A 5K7

  • Thunder Bay Regional Health Science Centre

    Thunder Bay, Ontario, P7B 6V4

  • Toronto General Hospital

    Toronto, Ontario, M5G 2C4

  • St. Joseph's Health Centre

    Toronto, M6R 1B5

Other trials in Canada

Russia10 sites

  • State Healthcare Institution "Arkhangelsk Regional Clinical Oncology Dispensary"

    Arkhangelsk, 163045

  • State Healthcare Institution "Regional Clinical Oncology Dispensary"

    Kemerovo, 650036

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

    Krasnodar, 350086

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

    Moscow, 105229

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

    Moscow, 115478

  • 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, 197022

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

    Saint Petersburg, 197758

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

    Saint Petersburg, 198255

  • Regional State Budget Healthcare Instiution"Tomsk Regional Oncology Dispensary"

    Tomsk, 634050

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

    Yaroslavl, 150040

Other trials in Russia

United Kingdom10 sites

  • Birmingham Heartlands Hospital

    Birmingham, B9 5SS

  • Bristol Haematology and Oncology Centre

    Bristol, BS2 8ED

  • Ninewells Hospital

    Dundee, DD1 9SY

  • Beatson West of Scotland Cancer Centre

    Glasgow, G12 0YN

  • The Royal Surrey County Hospital NHS Trust

    Guildford, GU2 7XX

  • Leicester Royal Infirmary

    Lecester, LE1 5WW

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

    Leeds, LS9 7TF

  • Guy's Hospital

    London, SE1 9RT

  • Royal Marsden Hospital

    London, SW3 6JJ

  • Royal Marsden Hospital

    Sutton, SM2 5PT

Other trials in United Kingdom

Australia8 sites

  • Respiratory Clinical Trials Pty., Ltd

    Adelaide, 5067

  • Ashford Cancer Centre

    Ashford, SA 5037

  • Campbelltown Hospital

    Campbelltown, New South Wales, 2560

  • Monash Medical Centre

    East Bentleigh, Victoria, 3165

  • St Vincent's Hospital Melbourne

    Fitzroy, Victoria, 3065

  • Austin Hospital

    Heidelberg, Victoria, 3084

  • Liverpool Hospital

    Liverpool, New South Wales, 2170

  • Royal North Shore Hospital

    St Leonards, New South Wales, 2065

Other trials in Australia

Austria7 sites

  • Universitaetsklinikum Innsbruck

    Innsbruck, 6020

  • Allgemeines Krankenhaus der Stadt Linz

    Linz, 4021

  • Landeskrankenhaus SalzburgUniversitaetsklinikum der PMUUniversitaetsklinik für Pneumologie

    Salzburg, 5020

  • AKH Wien

    Vienna, 1090

  • Krankenhaus Hietzing

    Vienna, 1130

  • SMZ Baumgartner Hoehe - Otto Wagner Spital

    Vienna, 1140

  • SMZ Baumgartner Höhe - Otto- Wagner-Spital

    Vienna, A-1140

Other trials in Austria

Italy7 sites

  • Azienda Ospedaliero Universitaria Ospedali Riuniti Umberto I

    Ancona, 60020

  • Ospedale Bellaria

    Bologna, 40139

  • Ospedale Garibaldi Nesima

    Catania, 95100

  • Istituto Nazionale per la Ricerca e la Cura del Cancro

    Genova, 16132

  • Azienda Ospedaliero- Universitaria di Parma

    Parma, 43100

  • Ospedale S. Maria della Misericordia

    Perugia, 06132

  • Azienda Ospedaliera San Camillo Forlanini

    Roma, 00152

Other trials in Italy

Romania7 sites

  • Institutul Oncologic Al. Trestioreanu Sectia Oncologie Medicala II

    Bucharest, 022328

  • Institutul Oncologic Al. Trestioreanu

    Bucharest, 022328

  • Institutul Oncologic Prof. Dr. Ion Chiricuta

    Cluj-Napoca, 400015

  • Oncoloab SRL

    Craiova, Dolj, 200535

  • Centrul de Oncologie Medicala

    Iași, Iaşi, 700106

  • Spitalui Clinic Judetean de Urgenta, Sectia de Oncologie

    Oradea, Bihor County, 410032

  • Spitalul Clinic Judetean Sibiu

    Sibiu, 550245

Other trials in Romania

Taiwan7 sites

  • Changhua Christian Hospital

    Changhua, 500-06

  • Chang Gung Medical Foundation

    Kaohsiung City, 833

  • Chung Shan Medical University Hospital

    Taichung, 402

  • China Medical University Hospital

    Taichung, 404

  • Taichung Veterans General Hospital

    Taichung, 407

  • Taipei Veterans General Hospital

    Taipei, 112

  • Chang Gung Memorial Hospital

    Taoyuan, 333

Other trials in Taiwan

Hungary6 sites

  • Országos Korányi TBC és Pulmonológiai Intézet

    Budapest, 1121

  • Semmelweis Egyetem Altalanos Orvostudomanyi Kar Pulmonologiai Klinika

    Budapest, 1125

  • Csongrad Megyei Onkormanyzat, Mellkasi Betegsegek Szakkorhaza

    Deszk, 6772

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

    Pécs, 7623

  • Fejer Megyei Szent Gyorgy Korhaz

    Székesfehérvár, 8000

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

    Szombathely, 9700

Other trials in Hungary

Poland6 sites

  • Samodzielny Publiczny Szpital Kliniczny Nr 4

    Lublin, 20-954

  • Mazowieckie Centrum Leczenia Chorob Pluc i Gruzlicy

    Otwock, 05-400

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

    Poznan, 60-569

  • Specjalistyczny Szpital im. prof.Alfreda Sokolowskiego

    Szczecin, 70-891

  • Centrum Onkologii - Instytut im. Marii Skllodowskiej - Curie

    Warsaw, 02-781

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

    Wroclaw, 53-439

Other trials in Poland

Argentina5 sites

  • Hospital Italiano de Buenos Aires

    Buenos Aires, C1181ACH

  • Hospital de Rehabilitación Respiratoria María Ferrer

    Buenos Aires, C1272AAA

  • COIR

    Mendoza, Mendoza Province, M5500AYB

  • Hospital Espanol de Rosario

    Rosario, Santa Fe, S2001SBL

  • ISIS Centro Especializado De Luce S.A.

    Santa Fe, Santa Fe Province, S3000FFU

Other trials in Argentina

South Korea5 sites

  • Saint Vincent's Hospital

    Gyeonggi-do, 442-723

  • Gachon Medical School Ghil Medical Center

    Incheon, 405-760

  • Seoul National University Hospital

    Seoul, 110-744

  • Severance Hospital, Yonsei Univ. College of Medicine

    Seoul, 120-752

  • Asan Medical Center

    Seoul, 138-736

Other trials in South Korea

Belgium4 sites

  • Hôpital Erasme

    Brussels, 1070

  • Cliniques Universitaires Saint-Luc

    Brussels, 1200

  • Le Grand Hôpital de Charleroi

    Charleroi, 6000

  • Centre Hospitalier Jolimont-Lobbes

    La Louvière, 7100

Other trials in Belgium

Czechia3 sites

  • Nemocnice Ceske Budejovice, a.s.

    České Budějovice, 370 87

  • Fakultni nemocnice OstravaKlinika tuberkulozy a respiracnich nemoci

    Ostrava-Poruba, 70852

  • FN Bulovka Klinika plincni a hrrudni chirurgie

    Prague, 8 18081

Other trials in Czechia

Greece3 sites

  • IASO GENERAL Hospital of Athens

    Athens, 15562

  • "Papageorgiou" General Hospital of Thessaloniki

    Thessaloniki, 54603

  • "G. Papanikolaou" General Hospital of Thessaloniki

    Thessaloniki, 57010

Other trials in Greece

About this study

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

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.

Read the 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.

Being tested
Erlotinib, Placebo
Keywords
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
Medical subject headings
Carcinoma, Non-Small-Cell Lung, Lung Neoplasms

What participants receive

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

  • ErlotinibDrug

    Also called OSI-774, Tarceva

    150 mg tablet

  • PlaceboDrug

    Placebo tablet

Study groups in NCT00373425
Study groupRoleWhat they receive
ErlotinibExperimentalParticipants 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.
Receives: Drug: Erlotinib
PlaceboPlacebo comparatorParticipants received matching placebo tablets orally for 2 years or until relapse, death, participant request or investigator decision to discontinue study drug, or intolerable toxicity.
Receives: Drug: Placebo

What is being measured

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

  1. Disease Free Survival (DFS)

    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.

    Measured: Every 3 months during active phase and every 6 months during long term follow-up up to 5 years and yearly thereafter until the data cut-off date of 08 April 2013 (maximum time on follow-up was 64 months).

  2. Disease Free Survival (DFS)

    DFS is the time from the date of randomization until the first day that 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.

    Measured: Every 3 months during active phase and every 6 months during long term follow-up up to 5 years and yearly thereafter until the data cutoff date of 11 June 2014 (maximum time on follow-up was 78 months).

Secondary outcomes (7)

  1. Overall Survival (OS)

    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.

    Measured: Every 3 months during active phase and every 6 months during long term follow-up up to 5 years and yearly thereafter until the data cut-off date of 08 April 2013 (maximum time on follow-up was 64 months).

  2. Overall Survival (OS)

    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.

    Measured: Every 3 months during active phase and every 6 months during long term follow-up up to 5 years and yearly thereafter until the data cut-off date of 11 June 2014 (maximum time on follow-up was 78 months).

  3. Disease-free Survival in Participants With EGFR Mutation - Positive Tumors

    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.

    Measured: Every 3 months during active phase and every 6 months during long term follow-up up to 5 years and yearly thereafter until the data cut-off date of 08 April 2013 (maximum time on follow-up was 64 months).

  4. Disease-free Survival in Participants With EGFR Mutation - Positive Tumors

    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.

    Measured: Every 3 months during active phase and every 6 months during long term follow-up up to 5 years and yearly thereafter until the data cut-off date of 11 June 2014 (maximum time on follow-up was 78 months).

  5. Overall Survival in Participants With EGFR Mutation - Positive Tumors

    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.

    Measured: Every 3 months during active phase and every 6 months during long term follow-up up to 5 years and yearly thereafter until the data cut-off date of 08 April 2013 (maximum time on follow-up was 64 months)

  6. Overall Survival in Participants With EGFR Mutation - Positive Tumors

    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.

    Measured: Every 3 months during active phase and every 6 months during long term follow-up up to 5 years and yearly thereafter until the data cut-off date of 11 June 2014 (maximum time on follow-up was 78 months)

  7. Number of Participants With Adverse Events (AEs)

    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 existing hospitalization, persistent or significant disability/incapacity, congenital anomaly/birth defect in the offspring of a participant, other important medical events, or is on the Astellas Always Serious List.

    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. AEs leading to death include deaths that occurred more than 30 days after the last dose of study drug.

    Measured: 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. Data are based off the 11 June 2014 data cut-off date.

Timeline

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

  1. First posted8 Sep 2006 (estimated)
  2. Study startSep 2006
  3. Primary completionApr 2013
  4. Study completionJun 2014

Resources

More details

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

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
1,252 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00373425
Sponsor's protocol ID
OSI-774-302
Other IDs
2005-001747-29, 2005
Acronym
RADIANT
Status last verified
Sep 2015
First submitted
7 Sep 2006
Last updated
17 Sep 2015
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 26324372

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Erlotinib in people with Non-small Cell Lung Cancer, run by OSI Pharmaceuticals at 295 sites in 19 countries.

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

Who may be eligible to take part?

The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 295 sites in United States, Germany, Spain, France, Canada and 14 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

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

What does this phase mean?

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

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

Are results available for this study?

Yes. Results are posted in the registry (first posted 3 Jun 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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

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

What does the primary outcome measure?

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 until the data cut-off date of 08 April 2013 (maximum time on follow-up was 64 months).). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00373425, which also lists 1 linked publication.

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

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

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2015.

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