OSI-774 (Tarceva) in Treating Patients With Stage III or Stage IV Non-Small Cell Lung Cancer
A Randomized Placebo Controlled Study of OSI-774 (Erlotinib HCl, Tarceva[TM]) in Patients With Incurable Stage IIIB/IV Non-small Cell Lung Cancer Who Have Failed Standard Therapy for Advanced or Metastatic Disease
1 other identifier
interventional
731
17 countries
97
Brief Summary
The purpose of this study is to determine if OSI-774 will improve overall survival of patients with incurable stage IIIB/IV non-small cell lung cancer compared to standard of care. OSI-774 is a new type of drug under evaluation called an epidermal growth factor receptor (EGFR). OSI-774 is an investigational drug that has not yet been approved by the U.S. Food and Drug Administration (FDA).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Nov 2001
97 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2001
CompletedFirst Submitted
Initial submission to the registry
May 13, 2002
CompletedFirst Posted
Study publicly available on registry
May 14, 2002
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 30, 2004
CompletedStudy Completion
Last participant's last visit for all outcomes
January 30, 2004
CompletedJanuary 10, 2018
June 1, 2015
2.2 years
May 13, 2002
January 8, 2018
Conditions
Keywords
Interventions
Eligibility Criteria
Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.
Sponsors & Collaborators
- OSI Pharmaceuticalslead
- Canadian Cancer Trials Groupcollaborator
Study Sites (97)
University of Chicago Medical Center
Chicago, Illinois, 60637, United States
University of Washington
Seattle, Washington, 98109, United States
Centro Medico Confidence
Buenos Aires, CP, 1642, Argentina
Hospital Britanico
Buenos Aires, 1280, Argentina
Hospital Interzonal de Agudos Evita
Buenos Aires, B1824, Argentina
Instituto Alexander fleming
Buenos Aires, C1426ANZ, Argentina
Hospital Churruca Visca
Buenos Aires, C1427, Argentina
Instituto Oncologico Angel Roffo
Capital Federal, CP1417, Argentina
Hospital Italiano
Capital Federal, Argentina
Canberra Hospital- Australia
Woden, Australian Capital Territory, 2605, Australia
Prince of Wales Hospital
Randwick, New South Wales, 2031, Australia
Newcastle Mater Misericordiae Hospital
Waratah, New South Wales, 2289, Australia
Southern Medical Day Care Center
Wollongong, New South Wales, 2500, Australia
Western Hospital
Footscray, Victoria, 3011, Australia
The Royal Melbourne Hospital
Parkville, Victoria, 3050, Australia
Sir Charles Gairdner Hospital
Nedlands, Western Australia, 6009, Australia
Royal Adelaide Hospital
South Australia, 5000, Australia
Peter MacCallum Cancer Institute
Victoria, 3002, Australia
Austin & Repatriation Medical Centre
Victoria, 3084, Australia
Instituto do Cancer do Ceara
Fortaleza, CEP, 60430-230, Brazil
Instituto Nacional de Cancerologia
Rio de Janeiro, CEP, 20230-130, Brazil
Nucleo de Oncologia da Bahia
Salvador, Estado de Bahia, 40170-070, Brazil
Hospital Vera Cruz S/A
Belo Horizonte, MG CEP, 30190-130, Brazil
Irmandade Santa Casa de Miseicordia de Porto
Porto Alegre, RS CEP, 90020-090, Brazil
Hospital Sao Lucas da PUCRS
Porto Alegre, RS CEP, 90610-000, Brazil
Faculdade de Medicina do ABC
Santo André, SP CEP, 09060-650, Brazil
Escola Paulista de Medicina
São Paulo, SP CEP, 040039-032, Brazil
Instituto do Cancer Arnaldo Vieira de Carvalho
São Paulo, São Paulo, 01224-010, Brazil
Tom Baker Cancer Centre
Calgary, Alberta, T2N 4N2, Canada
Cross Cancer Institute
Edmonton, Alberta, T6G 1Z2, Canada
Cancer Centre for the Southern Interior
Kelowna, British Columbia, V1Y 5L3, Canada
BCCA - Vancouver Island
Victoria, British Columbia, V8R 6V5, Canada
CancerCare Manitoba (CCMB)
Winnipeg, Manitoba, R3E 0V9, Canada
Dr.H. Bliss Murphy Cancer Centre
St. John's, Newfoundland and Labrador, A1B 3V6, Canada
QEII Health Sciences Centre
Halifax, Nova Scotia, B3H 2Y9, Canada
The Royal Victoria Hospital
Barrie, Ontario, L4M 6M2, Canada
Northeastern Ontario Regional Cancer Centre
Greater Sudbury, Ontario, P3E 5J1, Canada
Hamilton Regional Cancer Centre
Hamilton, Ontario, L9V 5C2, Canada
Kingston Regional Cancer Centre
Kingston, Ontario, K7L 5P9, Canada
Credit Valley Hospital
Missisauga, Ontario, L5M 2N1, Canada
Southlake Regional Health Centre
Newmarket, Ontario, L3Y 2P9, Canada
Ottawa Regional Cancer Centre
Ottawa, Ontario, K1H 1C4, Canada
Peterborough Regional Health Centre
Peterborough, Ontario, K9H 7B6, Canada
Hotel Dieu Health Sciences Hospital
Saint Catherines, Ontario, L2R 5K3, Canada
Group Health Centre
Sault Saint Marie, Ontario, P6A 2C4, Canada
Toronto East General Hospital
Toronto, Ontario, M4C 3E7, Canada
Toronto-Sunnybrook Reg.Canc.Center
Toronto, Ontario, M4N 3M5, Canada
Mount Sinai Hospital
Toronto, Ontario, M5G 1X5, Canada
Princess Margaret Hospital
Toronto, Ontario, M5G 2M9, Canada
Humbar River Regional Hospital
Weston, Ontario, M9N 1N8, Canada
Hopital Notre-Dame du CHUM
Montreal, Quebec, H2L 4M1, Canada
McGill University
Montreal, Quebec, H2W 1S6, Canada
Hopital Du Sacre - Coeur De Montreal
Montreal, Quebec, H4J 1C5, Canada
Hopital Laval
Ste-Foy, Quebec, G1V 4G5, Canada
Allan Blair Cancer Centre
Regina, Saskatchewan, S4T 7T1, Canada
Institution: Clinica Las Condes
Santiago, Chile
Pamela Youde Nethersole Easter Hospital
Hong Kong, China
Queen Mary Hospital
Hong Kong, China
Lungenklinik Heckeshorn
Berlin, 14109, Germany
Asklepios Fachkiniken
Gauting, 82131, Germany
Zentrum fur pheulmologie und Thoraxchirurgie
Großhansdorf, 22927, Germany
Thoraxklinik Heidelberg
Heidelberg, 69126, Germany
Lungenklinik Hermer
Hermer, 58675, Germany
Sotiria Hospital
Athens, 115 27, Greece
Haemek Medical Center
Afula, 18101, Israel
RAMBAM Medical Center
Haifa, Israel
Rabin Medical Center Beilinson Campus
Petach-Tiqva, 49100, Israel
Rabin Medical Center Golda Campus
Petach-Tiqva, 49372, Israel
Kaplan Medical Center
Rehovot, Israel
Sourasky Medical Center Oncology Institute
Tel Aviv, 64239, Israel
Sheba Medical Center Oncology Day Care
Tel Litwinsky, 52621, Israel
Assaf Harofeh Medical Center
Ẕerifin, 70300, Israel
Instituto Nacional de Cancerologia
Mexico City, CP, 14000, Mexico
Centro Estatal de Cancerologia de Durango
Durango, Mexico
Hospital Central Sur de Alta Especialidad, PEMEX
Mexico City, Mexico
Wellington Hospital
Riddiford Street, Wellington Region, New Zealand
Greenlane Hospital - New Zealand
Auckland, New Zealand
Oncology Institute Bucharest
Bucharest, Romania
Oncology Institute Ion Chiricuta
Cluj-Napoca, 3400, Romania
Spitalul Universitar
Iași, 6600, Romania
Clinical County Hospital
Sibiu, 2400, Romania
National University Hospital
Singapore, 119074, Singapore
National Cancer Centre - Singapore
Singapore, 169610, Singapore
Durban Oncology Centre
Westbridge, Durban, 4091, South Africa
Die Wilgers Hospital
Lynnwood, Pretoria, South Africa
Oncotherapy Dept, National Hospital
Bloemfontein, 9301, South Africa
Sandton Oncology Centre
Parklands, 2121, South Africa
Johannesburg Hospital
Parktown, 2193, South Africa
Eastern Cape Oncology Centre
Port Elizabeth, 6000, South Africa
Mary Potter Oncology Centre
Pretoria, South Africa
University of Pretoria
Pretoria, South Africa
Rosebank Clinic Oncology Unit
Rosebank, South Africa
Lund University Hospital
Lund, Sweden
Sahlgrenska University Hospital
Lund, Sweden
Pramongkutklao Hospital
Phayathai, Bangkok, 10400, Thailand
Div. of Med Onc. The National Cancer Institute of Thailand
Bangkok, 10400, Thailand
Chiangmai University
Chiang Mai, 50002, Thailand
Related Publications (2)
Shepherd FA, Rodrigues Pereira J, Ciuleanu T, Tan EH, Hirsh V, Thongprasert S, Campos D, Maoleekoonpiroj S, Smylie M, Martins R, van Kooten M, Dediu M, Findlay B, Tu D, Johnston D, Bezjak A, Clark G, Santabarbara P, Seymour L; National Cancer Institute of Canada Clinical Trials Group. Erlotinib in previously treated non-small-cell lung cancer. N Engl J Med. 2005 Jul 14;353(2):123-32. doi: 10.1056/NEJMoa050753.
PMID: 16014882BACKGROUNDTsao MS, Sakurada A, Cutz JC, Zhu CQ, Kamel-Reid S, Squire J, Lorimer I, Zhang T, Liu N, Daneshmand M, Marrano P, da Cunha Santos G, Lagarde A, Richardson F, Seymour L, Whitehead M, Ding K, Pater J, Shepherd FA. Erlotinib in lung cancer - molecular and clinical predictors of outcome. N Engl J Med. 2005 Jul 14;353(2):133-44. doi: 10.1056/NEJMoa050736.
PMID: 16014883BACKGROUND
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Frances Shephard, M.D.
Princess Margaret Hospital, Canada
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
May 13, 2002
First Posted
May 14, 2002
Study Start
November 1, 2001
Primary Completion
January 30, 2004
Study Completion
January 30, 2004
Last Updated
January 10, 2018
Record last verified: 2015-06