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)
Non-small Cell Lung Cancer

About this trial
This is an interventional treatment trial for Non-small Cell Lung Cancer focused on measuring 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
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.
Sites / Locations
- University of Alabama at Birmingham
- Arizona Cancer Center
- University of Arkansas for Medical Science
- Tower Cancer Research Foundation
- City of Hope Nat'l Medical Center
- Loma Linda University Medical Center
- USC/ Norris Comprehensive Cancer Center
- Cedars-Sinai Medical Center
- Hoag Memorial Hospital Presbyterian
- Comprehensive Cancer Center at Desert Regional Medical Center
- Bay Area Cancer Research Group, LLC
- University of California, San Francisco Comprehensive Cancer Center
- City of Hope Medical Group (COHMG)
- Rocky Mountain Cancer Center- Aurora
- University of Colorado Hospital
- Rocky Mountain Cancer Centers-Boulder
- Penrose St. Francis Health Services
- Rocky Mountain Cancer Center
- Rocky Mountain Cancer Center
- Rocky Mountain Cancer Center-Midtown
- Rocky Mountain Cancer Centers- Rose
- Rocky Mountain Cancer Centers
- Rocky Mountain Cancer Centers-Littleton
- Rocky Mountain Cancer Center-Sky Ridge
- Rocky Mountain Cancer Centers-Longmont
- Rocky Mountain Cancer Center-Parker
- Rocky Mountain Cancer Centers
- Yale University
- Smilow Cancer Hospital Care Center
- Hematology Oncology, P.C.
- Smilow Cancer Hospital Care Center
- Florida Cancer Institute-New Hope
- Cancer Specialists of North Florida
- Cancer Specialists of North Florida
- Watson Clinic LLP
- Advanced Medical Specialties
- Florida Cancer Institute- New Hope
- Florida Cancer Specialists
- Hematology Oncology Associates of the Treasure Coast
- Peachtree Hematology-Oncology Consultants, P.C.
- Central Georgia Cancer Care, PC
- Northwest Georgia Oncology Centers, PC
- Mountain States Tumor Institute
- Mountain States Tumor Institute
- Kootenai Cancer Center
- Mountain States Tumor Institute
- Rush University Medical Center
- University of Chicago, Section of Hematology/Oncology
- Joliet Oncology Hematology Assoc., LTD
- Loyola University Medical Center
- Indiana University Health
- Indiana University Health
- Indiana University Health
- Indiana University Health
- Indiana University Health
- University of Kansas Medical Center
- Norton Healthcare, Inc.
- Leonard J. Chabert Medical Center
- Cancer Care of Maine
- Greater Baltimore Medical Center
- St. Joseph Medical Center's Cancer Institute
- Caritas St. Elizabeth's Medical Center
- St. Joseph Mercy Hospital
- Minnesota Oncology Hematology, P.A.
- Minnesota Oncology Hematology, P.A.
- Minnesota Oncology Hematology, P.A.
- Minnesota Oncology Hematology, P.A.
- Minnesota Oncology Hematology
- Minnesota Oncology Hematology, P.A.
- Missouri Cancer Associates
- Heartland Regional Medical Center d/b/a Heartland Clinic
- St. Francis Cancer Treatment Center
- Nebraska Methodist Hospital
- Comprehensive Cancer Centers of Nevada
- Comprehensive Cancer Centers of Nevada
- Comprehensive Cancer Centers of Nevada
- Comprehensive Cancer Centers of Nevada
- NH Oncology-Hematology PA (Co)
- NH Oncology-Hematology PA
- Dartmouth-Hitchcock Medical Center
- Hackensack University Medical Center
- University of New Mexico Health Science Center
- Christus St. Vincent Regional Cancer Center
- Interlakes Oncology Hematology, PC
- Montefiore Medical Center
- Interlakes Oncology Hematology, PC
- Interlakes Oncology Hematology, PC
- Advanced Oncology Associates
- The New York Presbyterian-Weill Medical College of Cornell University
- Interlakes Oncology Hematology, PC
- Interlakes Oncology Hematology, PC
- Stony Brook University Medical Center
- Raleigh Hematology Oncology Associates d/b/a Cancer Center of North Carolina
- Carolina Oncology Specialists PA
- Raleigh Hematology Oncology Associates
- Raleigh Hematology Oncology Associates
- Aultman Hospital/ North Canton Medical Foundation
- University Hopsitals of Cleveland
- Hematology Oncology Consultants Inc.
- Earle A Chiles Research Institute
- Northwest Cancer Specialists, PC
- Northwest Cancer Specialists, PC
- Northwest Cancer Specialists, PC
- Northwest Cancer Specialists, PC
- Cancer Care Associates - Medical Oncology
- The Hospital of the University of Pennsylvania
- Allegheny General Hospital
- South Carolina Oncology Assoc., PA
- Cancer Centers of the Carolinas
- Cancer Centers of the Carolinas
- Cancer Centers of the Carolinas
- Cancer Centers of the Carolinas, Seneca
- Cancer Centers of the Carolinas
- Cookeville Regional Medical Center
- Bostin Baskin Cancer Foundation
- Tennessee Cancer Specialists
- Bostin Baskin Cancer Foundation
- Family Cancer Center Foundation, Inc.
- West Clinic
- Sarah Cannon Cancer Center
- Sarah Cannon Research Institute
- Texas Oncology, P.A. - Amarillo
- Texas Oncology Beaumont
- Texas Oncology Texas Cancer Center at Medical City
- Baylor Charles A Sammons Cancer Center
- Texas Oncology - Flower Mound
- Texas Oncology Southwest Forth Worth
- Texas Oncology, Fort Worth
- Texas Oncology, Garland
- Cancer Care Centers of South Texas - HOAST
- Texas Oncology - Paris
- Texas Oncology - Plano East
- Cancer Care Centers of South Texas-HOAST
- Texas Oncology -Tyler
- Texas Oncology Cancer Care and Research Center
- Onc and Hem Associates of SW VA, Inc. d/b/a Blue Ridge Cancer Care
- Onc and Hem Associates of SW VA, Inc.
- Virginia Oncology Associates
- Virginia Oncology Associates
- Virginia Oncology Associates
- Onc and Hem Associates of SW VA, Inc. d/b/a Blue Ridge Cancer Care
- Onc and Hem Assoc of SW VA, Inc d/b/a Blue Ridge Cancer Care
- Onc and Hem Associates of SW VA, Inc. d/b/a Blue Ridge Cancer Care
- Univ. of Washington/ Seattle Cancer Care Alliance
- Cancer Care Northwest-Valley
- Cancer Care Northwest
- Cancer Care Northwest-North
- Northwest Cancer Specialists, P.C.
- Northwest Cancer Specialist, P.C.
- Hospital Italiano de Buenos Aires
- Hospital de Rehabilitación Respiratoria María Ferrer
- COIR
- Hospital Espanol de Rosario
- ISIS Centro Especializado De Luce S.A.
- Campbelltown Hospital
- Liverpool Hospital
- Royal North Shore Hospital
- Monash Medical Centre
- St Vincent's Hospital Melbourne
- Austin Hospital
- Respiratory Clinical Trials Pty., Ltd
- Ashford Cancer Centre
- Universitaetsklinikum Innsbruck
- Allgemeines Krankenhaus der Stadt Linz
- Landeskrankenhaus SalzburgUniversitaetsklinikum der PMUUniversitaetsklinik für Pneumologie
- AKH Wien
- Krankenhaus Hietzing
- SMZ Baumgartner Hoehe - Otto Wagner Spital
- SMZ Baumgartner Höhe - Otto- Wagner-Spital
- Hôpital Erasme
- Cliniques Universitaires Saint-Luc
- Le Grand Hôpital de Charleroi
- Centre Hospitalier Jolimont-Lobbes
- Cross Cancer Institute
- Cancer Center of Southeastern Ontario at Kingston General Hospital
- Trillium Health Partners - Credit Valley Hospital
- Stronach Regional cancer Centre at Southlake
- RS MacLaughlin Durham Regional Cancer Centre
- Sault Area Hospital
- Thunder Bay Regional Health Science Centre
- Toronto General Hospital
- McGill Dept. of Oncology
- Royal Victoria Hospital
- Montreal General Hospital
- St. Joseph's Health Centre
- Nemocnice Ceske Budejovice, a.s.
- Fakultni nemocnice OstravaKlinika tuberkulozy a respiracnich nemoci
- FN Bulovka Klinika plincni a hrrudni chirurgie
- CHU Larrey Service de Pneumologie, Clinique des voies respiratoires
- Centre d'Oncologie et de Radiothérapie du Pays Basque
- C.H.U. Morvan, Institut de Cancerologie et d'Hématologie
- CHU de Caen - Service de pneumologie
- CHU Clermont Ferrand - Hôpital Gabriel Montpied - Service de pneumologie
- Hopital De La Croix-Rousse Service de Pneumologie
- Institut Paoli-Calmettes
- Fondation Hôpital Saint Joseph
- Hôpital de Tenon
- Centre Catalan d'Oncologie
- CHU - Hopital Pontchaillou - Service de pneumologie
- Institut de Cancérologie de la Loire
- Hôpital de Brabois
- Zentralklinik Bad Berka
- HELIOS Klinikum Emil von Behring GmbH
- Augusta-Krankenanstalt Bochum
- Fachkrankenhaus Coswig
- Universitaetsklinikum Essen
- Krankenhaus Nordwest
- Universitätsklinikum Freiburg
- Lungenclinic Großhansdorf
- Universitätsklinikum Göttingen
- Städtisches Krankenhaus Martha-Maria, Halle-Dölau
- Asklepios Klinik Harburg
- Thoraxklinik Heidelberg
- Lungenklink Hemer des Deutschen Gemeinschafts-Diakonieverbandes GmbH
- St. Vincentius-Kliniken Karlsruhe
- Universitaetsklinikum Schleswig-Holstein
- Universitätsklinikum Mainz
- Asklepios Klinikum Gauting
- Pius Hospital Oldenburg
- Schwarzwald-Baar Klinikum
- IASO GENERAL Hospital of Athens
- "Papageorgiou" General Hospital of Thessaloniki
- "G. Papanikolaou" General Hospital of Thessaloniki
- Országos Korányi TBC és Pulmonológiai Intézet
- Semmelweis Egyetem Altalanos Orvostudomanyi Kar Pulmonologiai Klinika
- Csongrad Megyei Onkormanyzat, Mellkasi Betegsegek Szakkorhaza
- Pecsi Tudomany Egyete m Klinikai Kozpont, I.sz Belgyogyaszati Klinika Pulmonologiai Munkacsoport
- Fejer Megyei Szent Gyorgy Korhaz
- Vas Megyei Markusovszky Lajos Altalanos Rehabilitacios es Gyogyfurdo Korhaz, Egyetemi Oktatoko Zarkoruen Mukodo Nonprofit Reszveny Tarsasag
- Azienda Ospedaliero Universitaria Ospedali Riuniti Umberto I
- Ospedale Bellaria
- Ospedale Garibaldi Nesima
- Istituto Nazionale per la Ricerca e la Cura del Cancro
- Azienda Ospedaliero- Universitaria di Parma
- Ospedale S. Maria della Misericordia
- Azienda Ospedaliera San Camillo Forlanini
- Saint Vincent's Hospital
- Gachon Medical School Ghil Medical Center
- Seoul National University Hospital
- Severance Hospital, Yonsei Univ. College of Medicine
- Asan Medical Center
- Samodzielny Publiczny Szpital Kliniczny Nr 4
- Mazowieckie Centrum Leczenia Chorob Pluc i Gruzlicy
- Wielkoposkie Centrum Pulmonologii i Torakochirurgii, Oddzial Onkologii Klinicznej z Pododdzialem Dziennej Chemioterapii
- Specjalistyczny Szpital im. prof.Alfreda Sokolowskiego
- Centrum Onkologii - Instytut im. Marii Skllodowskiej - Curie
- Dolnoslaskie Centrum Chorob Pluc we Wroclawiu, Katedra i Klinika Pulmonologii i Nowotworow Pluc Akademii Medycznej
- Spitalui Clinic Judetean de Urgenta, Sectia de Oncologie
- Oncoloab SRL
- Institutul Oncologic Al. Trestioreanu Sectia Oncologie Medicala II
- Institutul Oncologic Al. Trestioreanu
- Institutul Oncologic Prof. Dr. Ion Chiricuta
- Centrul de Oncologie Medicala
- Spitalul Clinic Judetean Sibiu
- State Healthcare Institution "Arkhangelsk Regional Clinical Oncology Dispensary"
- State Healthcare Institution "Regional Clinical Oncology Dispensary"
- State Healthcare Institution "Region Clinical Hospital # 1 n.a. professor S.V. Ochapovsky"
- State Institution "Central Military Clinical Hospital n.a. academician N.N. Burdenko under the Ministry of Defense of Russia"
- Institution of the RAMS "Russian Oncology Scientific Centre n.a. N.N. Blokhin under the Russian Academy of Medical Sciences"
- 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"
- Federal State Institution "Petrov Scientific Research Institute of Oncology of Rosmedtechnology"
- Saint-Petersburg State Healthcare Institution "City Clinical Oncology Dispensary"
- Regional State Budget Healthcare Instiution"Tomsk Regional Oncology Dispensary"
- State Healthcare Institution of Yaroslavl Region "Regional Clinical Oncology Hospital"
- ICO (Institut Catalá d´Oncología)
- Fundació Althaia
- Corporació Sanitaria Parc Taulí
- Hospital Puerta de Hierro Majadahonda
- Hospital Oncologico MD Anderson
- Hospital Universitario 12 de Octubre
- Hospital Universitario La Paz
- Hospital Carlos Haya
- Hospital Clínico Virgen de la Victoria
- Clinica Universitaria de Navarra
- Hospital Universitario Marques de Valdecilla
- Hospital Universitario de Valme
- Hospital Virgen de la Salud de Toledo
- Hospital General Universitario de Valencia
- Changhua Christian Hospital
- Chang Gung Medical Foundation
- Chung Shan Medical University Hospital
- China Medical University Hospital
- Taichung Veterans General Hospital
- Taipei Veterans General Hospital
- Chang Gung Memorial Hospital
- Birmingham Heartlands Hospital
- Bristol Haematology and Oncology Centre
- Ninewells Hospital
- Beatson West of Scotland Cancer Centre
- The Royal Surrey County Hospital NHS Trust
- Leicester Royal Infirmary
- St James' Institute of Oncology, Bexley Wing, St James' University Hospital
- Guy's Hospital
- Royal Marsden Hospital
- Royal Marsden Hospital
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
Erlotinib
Placebo
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.
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.