Clinical trial NCT00373425: 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
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Non-small Cell Lung Cancer
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
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
First posted: 2006-09-08
Enrollment: 1252
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Disease Free Survival (DFS)
timeFrame: 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).
measure: Disease Free Survival (DFS)
timeFrame: 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:
measure: Overall Survival (OS)
timeFrame: 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).
measure: Overall Survival (OS)
timeFrame: 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).
measure: Disease-free Survival in Participants With EGFR Mutation - Positive Tumors
timeFrame: 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).
measure: Disease-free Survival in Participants With EGFR Mutation - Positive Tumors
timeFrame: 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).
measure: Overall Survival in Participants With EGFR Mutation - Positive Tumors
timeFrame: 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)
measure: Overall Survival in Participants With EGFR Mutation - Positive Tumors
timeFrame: 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)
measure: Number of Participants With Adverse Events (AEs)
timeFrame: 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.
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Tucson
country: United States
facility: Arizona Cancer Center
state: Arizona
city: Little Rock
country: United States
facility: University of Arkansas for Medical Science
state: Arkansas
city: Beverly Hills
country: United States
facility: Tower Cancer Research Foundation
state: California
city: Duarte
country: United States
facility: City of Hope Nat'l Medical Center
state: California
city: Loma Linda
country: United States
facility: Loma Linda University Medical Center
state: California
city: Los Angeles
country: United States
facility: USC/ Norris Comprehensive Cancer Center
state: California
city: Los Angeles
country: United States
facility: Cedars-Sinai Medical Center
state: California
city: Newport Beach
country: United States
facility: Hoag Memorial Hospital Presbyterian
state: California
city: Palm Springs
country: United States
facility: Comprehensive Cancer Center at Desert Regional Medical Center
state: California
city: Pleasant Hill
country: United States
facility: Bay Area Cancer Research Group, LLC
state: California
city: San Francisco
country: United States
facility: University of California, San Francisco Comprehensive Cancer Center
state: California
city: South Pasadena
country: United States
facility: City of Hope Medical Group (COHMG)
state: California
city: Aurora
country: United States
facility: Rocky Mountain Cancer Center- Aurora
state: Colorado
city: Aurora
country: United States
facility: University of Colorado Hospital
state: Colorado
city: Boulder
country: United States
facility: Rocky Mountain Cancer Centers-Boulder
state: Colorado
city: Colorado Springs
country: United States
facility: Penrose St. Francis Health Services
state: Colorado
city: Colorado Springs
country: United States
facility: Rocky Mountain Cancer Center
state: Colorado
city: Colorado Springs
country: United States
facility: Rocky Mountain Cancer Center
state: Colorado
city: Denver
country: United States
facility: Rocky Mountain Cancer Center-Midtown
state: Colorado
city: Denver
country: United States
facility: Rocky Mountain Cancer Centers- Rose
state: Colorado
city: Lakewood
country: United States
facility: Rocky Mountain Cancer Centers
state: Colorado
city: Littleton
country: United States
facility: Rocky Mountain Cancer Centers-Littleton
state: Colorado
city: Lone Tree
country: United States
facility: Rocky Mountain Cancer Center-Sky Ridge
state: Colorado
city: Longmont
country: United States
facility: Rocky Mountain Cancer Centers-Longmont
state: Colorado
city: Parker
country: United States
facility: Rocky Mountain Cancer Center-Parker
state: Colorado
city: Thornton
country: United States
facility: Rocky Mountain Cancer Centers
state: Colorado
city: New Haven
country: United States
facility: Yale University
state: Connecticut
city: Sharon
country: United States
facility: Smilow Cancer Hospital Care Center
state: Connecticut
city: Stamford
country: United States
facility: Hematology Oncology, P.C.
state: Connecticut
city: Torrington
country: United States
facility: Smilow Cancer Hospital Care Center
state: Connecticut
city: Hudson
country: United States
facility: Florida Cancer Institute-New Hope
state: Florida
city: Jacksonville
country: United States
facility: Cancer Specialists of North Florida
state: Florida
city: Jacksonville
country: United States
facility: Cancer Specialists of North Florida
state: Florida
city: Lakeland
country: United States
facility: Watson Clinic LLP
state: Florida
city: Miami
country: United States
facility: Advanced Medical Specialties
state: Florida
city: New Port Richey
country: United States
facility: Florida Cancer Institute- New Hope
state: Florida
city: Orlando
country: United States
facility: Florida Cancer Specialists
state: Florida
city: Port St. Lucie
country: United States
facility: Hematology Oncology Associates of the Treasure Coast
state: Florida
city: Atlanta
country: United States
facility: Peachtree Hematology-Oncology Consultants, P.C.
state: Georgia
city: Macon
country: United States
facility: Central Georgia Cancer Care, PC
state: Georgia
city: Marietta
country: United States
facility: Northwest Georgia Oncology Centers, PC
state: Georgia
city: Boise
country: United States
facility: Mountain States Tumor Institute
state: Idaho
city: Meridian
country: United States
facility: Mountain States Tumor Institute
state: Idaho
city: Post Falls
country: United States
facility: Kootenai Cancer Center
state: Idaho
city: Twin Falls
country: United States
facility: Mountain States Tumor Institute
state: Idaho
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
city: Chicago
country: United States
facility: University of Chicago, Section of Hematology/Oncology
state: Illinois
city: Joliet
country: United States
facility: Joliet Oncology Hematology Assoc., LTD
state: Illinois
city: Maywood
country: United States
facility: Loyola University Medical Center
state: Illinois
city: Carmel
country: United States
facility: Indiana University Health
state: Indiana
city: Fishers
country: United States
facility: Indiana University Health
state: Indiana
city: Greenfield
country: United States
facility: Indiana University Health
state: Indiana
city: Indianapolis
country: United States
facility: Indiana University Health
state: Indiana
city: Indianapolis
country: United States
facility: Indiana University Health
state: Indiana
city: Westwood
country: United States
facility: University of Kansas Medical Center
state: Kansas
city: Louisville
country: United States
facility: Norton Healthcare, Inc.
state: Kentucky
city: Houma
country: United States
facility: Leonard J. Chabert Medical Center
state: Louisiana
city: Brewer
country: United States
facility: Cancer Care of Maine
state: Maine
city: Baltimore
country: United States
facility: Greater Baltimore Medical Center
state: Maryland
city: Towson
country: United States
facility: St. Joseph Medical Center's Cancer Institute
state: Maryland
city: Boston
country: United States
facility: Caritas St. Elizabeth's Medical Center
state: Massachusetts
city: Ann Arbor
country: United States
facility: St. Joseph Mercy Hospital
state: Michigan
city: Burnsville
country: United States
facility: Minnesota Oncology Hematology, P.A.
state: Minnesota
city: Edina
country: United States
facility: Minnesota Oncology Hematology, P.A.
state: Minnesota
city: Maplewood
country: United States
facility: Minnesota Oncology Hematology, P.A.
state: Minnesota
city: Minneapolis
country: United States
facility: Minnesota Oncology Hematology, P.A.
state: Minnesota
city: St. Paul
country: United States
facility: Minnesota Oncology Hematology
state: Minnesota
city: Woodbury
country: United States
facility: Minnesota Oncology Hematology, P.A.
state: Minnesota
city: Columbia
country: United States
facility: Missouri Cancer Associates
state: Missouri
city: St. Joseph
country: United States
facility: Heartland Regional Medical Center d/b/a Heartland Clinic
state: Missouri
city: Grand Island
country: United States
facility: St. Francis Cancer Treatment Center
state: Nebraska
city: Omaha
country: United States
facility: Nebraska Methodist Hospital
state: Nebraska
city: Henderson
country: United States
facility: Comprehensive Cancer Centers of Nevada
state: Nevada
city: Las Vegas
country: United States
facility: Comprehensive Cancer Centers of Nevada
state: Nevada
city: Las Vegas
country: United States
facility: Comprehensive Cancer Centers of Nevada
state: Nevada
city: Las Vegas
country: United States
facility: Comprehensive Cancer Centers of Nevada
state: Nevada
city: Concord
country: United States
facility: NH Oncology-Hematology PA (Co)
state: New Hampshire
city: Hooksett
country: United States
facility: NH Oncology-Hematology PA
state: New Hampshire
city: Lebanon
country: United States
facility: Dartmouth-Hitchcock Medical Center
state: New Hampshire
city: Hackensack
country: United States
facility: Hackensack University Medical Center
state: New Jersey
city: Albuquerque
country: United States
facility: University of New Mexico Health Science Center
state: New Mexico
city: Santa Fe
country: United States
facility: Christus St. Vincent Regional Cancer Center
state: New Mexico
city: Brockport
country: United States
facility: Interlakes Oncology Hematology, PC
state: New York
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
city: Canadaigua
country: United States
facility: Interlakes Oncology Hematology, PC
state: New York
city: Geneva
country: United States
facility: Interlakes Oncology Hematology, PC
state: New York
city: New Rochelle
country: United States
facility: Advanced Oncology Associates
state: New York
city: New York
country: United States
facility: The New York Presbyterian-Weill Medical College of Cornell University
state: New York
city: Rochester
country: United States
facility: Interlakes Oncology Hematology, PC
state: New York
city: Rochester
country: United States
facility: Interlakes Oncology Hematology, PC
state: New York
city: Stony Brook
country: United States
facility: Stony Brook University Medical Center
state: New York
city: Cary
country: United States
facility: Raleigh Hematology Oncology Associates d/b/a Cancer Center of North Carolina
state: North Carolina
city: Hickory
country: United States
facility: Carolina Oncology Specialists PA
state: North Carolina
city: Raleigh
country: United States
facility: Raleigh Hematology Oncology Associates
state: North Carolina
city: Raleigh
country: United States
facility: Raleigh Hematology Oncology Associates
state: North Carolina
city: Canton
country: United States
facility: Aultman Hospital/ North Canton Medical Foundation
state: Ohio
city: Cleveland
country: United States
facility: University Hopsitals of Cleveland
state: Ohio
city: Columbus
country: United States
facility: Hematology Oncology Consultants Inc.
state: Ohio
city: Portland
country: United States
facility: Earle A Chiles Research Institute
state: Oregon
city: Portland
country: United States
facility: Northwest Cancer Specialists, PC
state: Oregon
city: Portland
country: United States
facility: Northwest Cancer Specialists, PC
state: Oregon
city: Portland
country: United States
facility: Northwest Cancer Specialists, PC
state: Oregon
city: Tualatin
country: United States
facility: Northwest Cancer Specialists, PC
state: Oregon
city: Bethlehem
country: United States
facility: Cancer Care Associates - Medical Oncology
state: Pennsylvania
city: Philadelphia
country: United States
facility: The Hospital of the University of Pennsylvania
state: Pennsylvania
city: Pittsburg
country: United States
facility: Allegheny General Hospital
state: Pennsylvania
city: Columbia
country: United States
facility: South Carolina Oncology Assoc., PA
state: South Carolina
city: Easley
country: United States
facility: Cancer Centers of the Carolinas
state: South Carolina
city: Greenville
country: United States
facility: Cancer Centers of the Carolinas
state: South Carolina
city: Greenville
country: United States
facility: Cancer Centers of the Carolinas
state: South Carolina
city: Seneca
country: United States
facility: Cancer Centers of the Carolinas, Seneca
state: South Carolina
city: Spartanburg
country: United States
facility: Cancer Centers of the Carolinas
state: South Carolina
city: Cookeville
country: United States
facility: Cookeville Regional Medical Center
state: Tennessee
city: Germantown
country: United States
facility: Bostin Baskin Cancer Foundation
state: Tennessee
city: Knoxville
country: United States
facility: Tennessee Cancer Specialists
state: Tennessee
city: Memphis
country: United States
facility: Bostin Baskin Cancer Foundation
state: Tennessee
city: Memphis
country: United States
facility: Family Cancer Center Foundation, Inc.
state: Tennessee
city: Memphis
country: United States
facility: West Clinic
state: Tennessee
city: Nashville
country: United States
facility: Sarah Cannon Cancer Center
state: Tennessee
city: Nashville
country: United States
facility: Sarah Cannon Research Institute
state: Tennessee
city: Amarillo
country: United States
facility: Texas Oncology, P.A. - Amarillo
state: Texas
city: Beaumont
country: United States
facility: Texas Oncology Beaumont
state: Texas
city: Dallas
country: United States
facility: Texas Oncology Texas Cancer Center at Medical City
state: Texas
city: Dallas
country: United States
facility: Baylor Charles A Sammons Cancer Center
state: Texas
city: Flower Mound
country: United States
facility: Texas Oncology - Flower Mound
state: Texas
city: Fort Worth
country: United States
facility: Texas Oncology Southwest Forth Worth
state: Texas
city: Ft. Worth
country: United States
facility: Texas Oncology, Fort Worth
state: Texas
city: Garland
country: United States
facility: Texas Oncology, Garland
state: Texas
city: New Braunfels
country: United States
facility: Cancer Care Centers of South Texas - HOAST
state: Texas
city: Paris
country: United States
facility: Texas Oncology - Paris
state: Texas
city: Plano
country: United States
facility: Texas Oncology - Plano East
state: Texas
city: San Antonio
country: United States
facility: Cancer Care Centers of South Texas-HOAST
state: Texas
city: Tyler
country: United States
facility: Texas Oncology -Tyler
state: Texas
city: Waco
country: United States
facility: Texas Oncology Cancer Care and Research Center
state: Texas
city: Christiansburg
country: United States
facility: Onc and Hem Associates of SW VA, Inc. d/b/a Blue Ridge Cancer Care
state: Virginia
city: Christiansburg
country: United States
facility: Onc and Hem Associates of SW VA, Inc.
state: Virginia
city: Hampton
country: United States
facility: Virginia Oncology Associates
state: Virginia
city: Newport News
country: United States
facility: Virginia Oncology Associates
state: Virginia
city: Norfolk
country: United States
facility: Virginia Oncology Associates
state: Virginia
city: Roanoke
country: United States
facility: Onc and Hem Associates of SW VA, Inc. d/b/a Blue Ridge Cancer Care
state: Virginia
city: Salem
country: United States
facility: Onc and Hem Assoc of SW VA, Inc d/b/a Blue Ridge Cancer Care
state: Virginia
city: Wytheville
country: United States
facility: Onc and Hem Associates of SW VA, Inc. d/b/a Blue Ridge Cancer Care
state: Virginia
city: Seattle
country: United States
facility: Univ. of Washington/ Seattle Cancer Care Alliance
state: Washington
city: Spokane Valley
country: United States
facility: Cancer Care Northwest-Valley
state: Washington
city: Spokane
country: United States
facility: Cancer Care Northwest
state: Washington
city: Spokane
country: United States
facility: Cancer Care Northwest-North
state: Washington
city: Vancouver
country: United States
facility: Northwest Cancer Specialists, P.C.
state: Washington
city: Vancouver
country: United States
facility: Northwest Cancer Specialist, P.C.
state: Washington
city: Buenos Aires
country: Argentina
facility: Hospital Italiano de Buenos Aires
city: Buenos Aires
country: Argentina
facility: Hospital de Rehabilitación Respiratoria María Ferrer
city: Mendoza
country: Argentina
facility: COIR
city: Rosario, Santa Fe
country: Argentina
facility: Hospital Espanol de Rosario
city: Santa Fé
country: Argentina
facility: ISIS Centro Especializado De Luce S.A.
city: Campbelltown
country: Australia
facility: Campbelltown Hospital
state: New South Wales
city: Liverpool
country: Australia
facility: Liverpool Hospital
state: New South Wales
city: St Leonards
country: Australia
facility: Royal North Shore Hospital
state: New South Wales
city: East Bentleigh
country: Australia
facility: Monash Medical Centre
state: Victoria
city: Fitzroy
country: Australia
facility: St Vincent's Hospital Melbourne
state: Victoria
city: Heidelberg
country: Australia
facility: Austin Hospital
state: Victoria
city: Adelaide
country: Australia
facility: Respiratory Clinical Trials Pty., Ltd
city: Ashford
country: Australia
facility: Ashford Cancer Centre
city: Innsbruck
country: Austria
facility: Universitaetsklinikum Innsbruck
city: Linz
country: Austria
facility: Allgemeines Krankenhaus der Stadt Linz
city: Salzburg
country: Austria
facility: Landeskrankenhaus SalzburgUniversitaetsklinikum der PMUUniversitaetsklinik für Pneumologie
city: Wien
country: Austria
facility: AKH Wien
city: Wien
country: Austria
facility: Krankenhaus Hietzing
city: Wien
country: Austria
facility: SMZ Baumgartner Hoehe - Otto Wagner Spital
city: Wien
country: Austria
facility: SMZ Baumgartner Höhe - Otto- Wagner-Spital
city: Brussels
country: Belgium
facility: Hôpital Erasme
city: Brussels
country: Belgium
facility: Cliniques Universitaires Saint-Luc
city: Charleroi
country: Belgium
facility: Le Grand Hôpital de Charleroi
city: La Louvière
country: Belgium
facility: Centre Hospitalier Jolimont-Lobbes
city: Edmonton
country: Canada
facility: Cross Cancer Institute
state: Alberta
city: Kingston
country: Canada
facility: Cancer Center of Southeastern Ontario at Kingston General Hospital
state: Ontario
city: Mississauga
country: Canada
facility: Trillium Health Partners - Credit Valley Hospital
state: Ontario
city: Newmarket
country: Canada
facility: Stronach Regional cancer Centre at Southlake
state: Ontario
city: Oshawa
country: Canada
facility: RS MacLaughlin Durham Regional Cancer Centre
state: Ontario
city: Sault Ste Marie
country: Canada
facility: Sault Area Hospital
state: Ontario
city: Thunder Bay
country: Canada
facility: Thunder Bay Regional Health Science Centre
state: Ontario
city: Toronto
country: Canada
facility: Toronto General Hospital
state: Ontario
city: Montreal
country: Canada
facility: McGill Dept. of Oncology
state: Quebec
city: Montreal
country: Canada
facility: Royal Victoria Hospital
state: Quebec
city: Montreal
country: Canada
facility: Montreal General Hospital
state: Quebec
city: Toronto
country: Canada
facility: St. Joseph's Health Centre
city: Ceske Budejovice
country: Czech Republic
facility: Nemocnice Ceske Budejovice, a.s.
city: Ostrava-Poruba
country: Czech Republic
facility: Fakultni nemocnice OstravaKlinika tuberkulozy a respiracnich nemoci
city: Praha
country: Czech Republic
facility: FN Bulovka Klinika plincni a hrrudni chirurgie
city: Toulouse
country: France
facility: CHU Larrey Service de Pneumologie, Clinique des voies respiratoires
state: Cedex 9
city: Bayonne
country: France
facility: Centre d'Oncologie et de Radiothérapie du Pays Basque
city: Brest cedex
country: France
facility: C.H.U. Morvan, Institut de Cancerologie et d'Hématologie
city: Caen Cedex
country: France
facility: CHU de Caen - Service de pneumologie
city: Clermont-Ferrand cedex 1
country: France
facility: CHU Clermont Ferrand - Hôpital Gabriel Montpied - Service de pneumologie
city: Lyon cedex 04
country: France
facility: Hopital De La Croix-Rousse Service de Pneumologie
city: Marseille cedex 9
country: France
facility: Institut Paoli-Calmettes
city: PARIS cedex 14
country: France
facility: Fondation Hôpital Saint Joseph
city: Paris
country: France
facility: Hôpital de Tenon
city: Perpignan
country: France
facility: Centre Catalan d'Oncologie
city: Rennes cedex 9
country: France
facility: CHU - Hopital Pontchaillou - Service de pneumologie
city: Saint Priest en Jarez
country: France
facility: Institut de Cancérologie de la Loire
city: Vandoeuvre-lès-Nancy Cedex
country: France
facility: Hôpital de Brabois
city: Bad Berka
country: Germany
facility: Zentralklinik Bad Berka
city: Berlin
country: Germany
facility: HELIOS Klinikum Emil von Behring GmbH
city: Bochum
country: Germany
facility: Augusta-Krankenanstalt Bochum
city: Coswig
country: Germany
facility: Fachkrankenhaus Coswig
city: Essen
country: Germany
facility: Universitaetsklinikum Essen
city: Frankfurt/Main
country: Germany
facility: Krankenhaus Nordwest
city: Freiburg
country: Germany
facility: Universitätsklinikum Freiburg
city: Großhansdorf
country: Germany
facility: Lungenclinic Großhansdorf
city: Göttingen
country: Germany
facility: Universitätsklinikum Göttingen
city: Halle (Saale)
country: Germany
facility: Städtisches Krankenhaus Martha-Maria, Halle-Dölau
city: Hamburg
country: Germany
facility: Asklepios Klinik Harburg
city: Heidelberg
country: Germany
facility: Thoraxklinik Heidelberg
city: Hemer
country: Germany
facility: Lungenklink Hemer des Deutschen Gemeinschafts-Diakonieverbandes GmbH
city: Karlsruhe
country: Germany
facility: St. Vincentius-Kliniken Karlsruhe
city: Lübeck
country: Germany
facility: Universitaetsklinikum Schleswig-Holstein
city: Mainz
country: Germany
facility: Universitätsklinikum Mainz
city: Muenchen-Gauting
country: Germany
facility: Asklepios Klinikum Gauting
city: Oldenburg
country: Germany
facility: Pius Hospital Oldenburg
city: Villingen-Schwenningen
country: Germany
facility: Schwarzwald-Baar Klinikum
city: Athens
country: Greece
facility: IASO GENERAL Hospital of Athens
city: Thessaloniki
country: Greece
facility: "Papageorgiou" General Hospital of Thessaloniki
city: Thessaloniki
country: Greece
facility: "G. Papanikolaou" General Hospital of Thessaloniki
city: Budapest
country: Hungary
facility: Országos Korányi TBC és Pulmonológiai Intézet
city: Budapest
country: Hungary
facility: Semmelweis Egyetem Altalanos Orvostudomanyi Kar Pulmonologiai Klinika
city: Deszk
country: Hungary
facility: Csongrad Megyei Onkormanyzat, Mellkasi Betegsegek Szakkorhaza
city: Pécs
country: Hungary
facility: Pecsi Tudomany Egyete m Klinikai Kozpont, I.sz Belgyogyaszati Klinika Pulmonologiai Munkacsoport
city: Szekesfehervar
country: Hungary
facility: Fejer Megyei Szent Gyorgy Korhaz
city: Szombathely
country: Hungary
facility: Vas Megyei Markusovszky Lajos Altalanos Rehabilitacios es Gyogyfurdo Korhaz, Egyetemi Oktatoko Zarkoruen Mukodo Nonprofit Reszveny Tarsasag
city: Ancona
country: Italy
facility: Azienda Ospedaliero Universitaria Ospedali Riuniti Umberto I
city: Bologna
country: Italy
facility: Ospedale Bellaria
city: Catania
country: Italy
facility: Ospedale Garibaldi Nesima
city: Genova
country: Italy
facility: Istituto Nazionale per la Ricerca e la Cura del Cancro
city: Parma
country: Italy
facility: Azienda Ospedaliero- Universitaria di Parma
city: Perugia
country: Italy
facility: Ospedale S. Maria della Misericordia
city: Roma
country: Italy
facility: Azienda Ospedaliera San Camillo Forlanini
city: Gyeonggi-Do
country: Korea, Republic of
facility: Saint Vincent's Hospital
city: Incheon
country: Korea, Republic of
facility: Gachon Medical School Ghil Medical Center
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Severance Hospital, Yonsei Univ. College of Medicine
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Lublin
country: Poland
facility: Samodzielny Publiczny Szpital Kliniczny Nr 4
city: Otwock
country: Poland
facility: Mazowieckie Centrum Leczenia Chorob Pluc i Gruzlicy
city: Poznan
country: Poland
facility: Wielkoposkie Centrum Pulmonologii i Torakochirurgii, Oddzial Onkologii Klinicznej z Pododdzialem Dziennej Chemioterapii
city: Szczecin
country: Poland
facility: Specjalistyczny Szpital im. prof.Alfreda Sokolowskiego
city: Warsaw
country: Poland
facility: Centrum Onkologii - Instytut im. Marii Skllodowskiej - Curie
city: Wroclaw
country: Poland
facility: Dolnoslaskie Centrum Chorob Pluc we Wroclawiu, Katedra i Klinika Pulmonologii i Nowotworow Pluc Akademii Medycznej
city: Oradea
country: Romania
facility: Spitalui Clinic Judetean de Urgenta, Sectia de Oncologie
state: Bihor
city: Craiova
country: Romania
facility: Oncoloab SRL
state: Dolj
city: Bucuresti
country: Romania
facility: Institutul Oncologic Al. Trestioreanu Sectia Oncologie Medicala II
city: Bucuresti
country: Romania
facility: Institutul Oncologic Al. Trestioreanu
city: Cluj-Napoca
country: Romania
facility: Institutul Oncologic Prof. Dr. Ion Chiricuta
city: Iasi
country: Romania
facility: Centrul de Oncologie Medicala
city: Sibiu
country: Romania
facility: Spitalul Clinic Judetean Sibiu
city: Arkhangelsk
country: Russian Federation
facility: State Healthcare Institution "Arkhangelsk Regional Clinical Oncology Dispensary"
city: Kemerovo
country: Russian Federation
facility: State Healthcare Institution "Regional Clinical Oncology Dispensary"
city: Krasnodar
country: Russian Federation
facility: State Healthcare Institution "Region Clinical Hospital # 1 n.a. professor S.V. Ochapovsky"
city: Moscow
country: Russian Federation
facility: State Institution "Central Military Clinical Hospital n.a. academician N.N. Burdenko under the Ministry of Defense of Russia"
city: Moscow
country: Russian Federation
facility: Institution of the RAMS "Russian Oncology Scientific Centre n.a. N.N. Blokhin under the Russian Academy of Medical Sciences"
city: Saint-Petersburg
country: Russian Federation
facility: 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"
city: Saint-Petersburg
country: Russian Federation
facility: Federal State Institution "Petrov Scientific Research Institute of Oncology of Rosmedtechnology"
city: Saint-Petersburg
country: Russian Federation
facility: Saint-Petersburg State Healthcare Institution "City Clinical Oncology Dispensary"
city: Tomsk
country: Russian Federation
facility: Regional State Budget Healthcare Instiution"Tomsk Regional Oncology Dispensary"
city: Yaroslavl
country: Russian Federation
facility: State Healthcare Institution of Yaroslavl Region "Regional Clinical Oncology Hospital"
city: L' Hospitalet de Llobregat
country: Spain
facility: ICO (Institut Catalá d´Oncología)
state: Barcelona
city: Manresa
country: Spain
facility: Fundació Althaia
state: Barcelona
city: Sabadell
country: Spain
facility: Corporació Sanitaria Parc Taulí
state: Barcelona
city: Majadahonda
country: Spain
facility: Hospital Puerta de Hierro Majadahonda
state: Madrid
city: Madrid
country: Spain
facility: Hospital Oncologico MD Anderson
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre
city: Madrid
country: Spain
facility: Hospital Universitario La Paz
city: Málaga
country: Spain
facility: Hospital Carlos Haya
city: Málaga
country: Spain
facility: Hospital Clínico Virgen de la Victoria
city: Pamplona
country: Spain
facility: Clinica Universitaria de Navarra
city: Santander
country: Spain
facility: Hospital Universitario Marques de Valdecilla
city: Sevilla
country: Spain
facility: Hospital Universitario de Valme
city: Toledo
country: Spain
facility: Hospital Virgen de la Salud de Toledo
city: Valencia
country: Spain
facility: Hospital General Universitario de Valencia
city: Changhua
country: Taiwan
facility: Changhua Christian Hospital
city: Kaohsiung
country: Taiwan
facility: Chang Gung Medical Foundation
city: Taichung
country: Taiwan
facility: Chung Shan Medical University Hospital
city: Taichung
country: Taiwan
facility: China Medical University Hospital
city: Taichung
country: Taiwan
facility: Taichung Veterans General Hospital
city: Taipei
country: Taiwan
facility: Taipei Veterans General Hospital
city: Taoyuan
country: Taiwan
facility: Chang Gung Memorial Hospital
city: Birmingham
country: United Kingdom
facility: Birmingham Heartlands Hospital
city: Bristol
country: United Kingdom
facility: Bristol Haematology and Oncology Centre
city: Dundee
country: United Kingdom
facility: Ninewells Hospital
city: Glasgow
country: United Kingdom
facility: Beatson West of Scotland Cancer Centre
city: Guildford
country: United Kingdom
facility: The Royal Surrey County Hospital NHS Trust
city: Lecester
country: United Kingdom
facility: Leicester Royal Infirmary
city: Leeds
country: United Kingdom
facility: St James' Institute of Oncology, Bexley Wing, St James' University Hospital
city: London
country: United Kingdom
facility: Guy's Hospital
city: London
country: United Kingdom
facility: Royal Marsden Hospital
city: Sutton
country: United Kingdom
facility: Royal Marsden Hospital
Study officials:
affiliation: Astellas Pharma Global Development
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: 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.