Iressa vs Best Supportive Care - 2nd/3rd Line Survival Study
April 22, 2009 updated by: AstraZeneca
A Double Blind,Placebo Controlled,Parallel Group,Multicentre,Randomised,Phase Iii Survival Study Comparing ZD1839 (IRESSA™)(250mg Tablet) Plus Best Supportive Care Versus Placebo Plus Best Supportive Care In Patients With Advanced NSCLC Who Have Received One Or Two Prior Chemotherapy Regimens And Are Refractory Or Intolerant To Their Most Recent Regimen
This study is being carried out to see if adding ZD1839 to other standard supportive care is more effective than standard supportive care alone for the treatment of patients with NSCLC whose disease has recurred after previous chemotherapy treatment.
Study Overview
Study Type
Interventional
Enrollment
1692
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Bahia Blanca, Argentina
- Research Site
-
Buenos Aires, Argentina
- Research Site
-
La Plata, Argentina
- Research Site
-
Mar del Plata, Argentina
- Research Site
-
Rosario, Argentina
- Research Site
-
Santa Fe, Argentina
- Research Site
-
-
Buenos Aires
-
Capital Federal, Buenos Aires, Argentina
- Research Site
-
-
-
-
-
Woodville South, Australia
- Research Site
-
-
New South Wales
-
Concord, New South Wales, Australia
- Research Site
-
Potts Point, New South Wales, Australia
- Research Site
-
St. Leonards, New South Wales, Australia
- Research Site
-
-
Queensland
-
Chermside, Queensland, Australia
- Research Site
-
South Brisbane, Queensland, Australia
- Research Site
-
-
South Australia
-
Ashford, South Australia, Australia
- Research Site
-
Woodville, South Australia, Australia
- Research Site
-
-
Victoria
-
Melbourne, Victoria, Australia
- Research Site
-
Parkville, Victoria, Australia
- Research Site
-
Prahran, Victoria, Australia
- Research Site
-
Wodonga, Victoria, Australia
- Research Site
-
-
-
-
CE
-
Fortaleza, CE, Brazil
- Research Site
-
-
MG
-
Belo Horizonte, MG, Brazil
- Research Site
-
-
RJ
-
Rio de Janeiro, RJ, Brazil
- Research Site
-
-
RS
-
Porto Alegre, RS, Brazil
- Research Site
-
-
SP
-
Sao Paulo, SP, Brazil
- Research Site
-
Sorocaba, SP, Brazil
- Research Site
-
-
-
-
-
Pleven, Bulgaria
- Research Site
-
Plovdiv, Bulgaria
- Research Site
-
Sofia, Bulgaria
- Research Site
-
Stara zagora, Bulgaria
- Research Site
-
Varna, Bulgaria
- Research Site
-
Veliko Tarnovo, Bulgaria
- Research Site
-
-
-
-
Alberta
-
Calgary, Alberta, Canada
- Research Site
-
Edmonton, Alberta, Canada
- Research Site
-
-
New Brunswick
-
Monoton, New Brunswick, Canada
- Research Site
-
-
Ontario
-
Mississauga, Ontario, Canada
- Research Site
-
Newmarket, Ontario, Canada
- Research Site
-
St. Catherines, Ontario, Canada
- Research Site
-
Sudbury, Ontario, Canada
- Research Site
-
Toronto, Ontario, Canada
- Research Site
-
York, Ontario, Canada
- Research Site
-
-
Quebec
-
Laval, Quebec, Canada
- Research Site
-
Montreal, Quebec, Canada
- Research Site
-
Ste-Foy, Quebec, Canada
- Research Site
-
-
-
-
-
Various Cities, Chile
- Research Site
-
-
-
-
-
Talinn, Estonia
- Research Site
-
Tartu, Estonia
- Research Site
-
-
-
-
-
Frankfurt, Germany
- Research Site
-
Freiburg, Germany
- Research Site
-
Gauting, Germany
- Research Site
-
Grobhansdorf, Germany
- Research Site
-
Hamburg, Germany
- Research Site
-
Heidelberg, Germany
- Research Site
-
Hemer, Germany
- Research Site
-
Muchen, Germany
- Research Site
-
-
Baden-Wurttemberg
-
Freiburg, Baden-Wurttemberg, Germany
- Research Site
-
Heidelberg, Baden-Wurttemberg, Germany
- Research Site
-
-
Bayern
-
Muchen, Bayern, Germany
- Research Site
-
-
Hessen
-
Frankfurt, Hessen, Germany
- Research Site
-
-
Nordrhein-Westfalen
-
Munster, Nordrhein-Westfalen, Germany
- Research Site
-
-
Schleswig-Holstein
-
Bad Segeberg, Schleswig-Holstein, Germany
- Research Site
-
-
-
-
-
Athens, Greece
- Research Site
-
Heraklion, Greece
- Research Site
-
Marousi, Greece
- Research Site
-
Thessaloniki, Greece
- Research Site
-
-
-
-
-
Budapest, Hungary
- Research Site
-
Debrecen, Hungary
- Research Site
-
Deszk, Hungary
- Research Site
-
Kecskemet, Hungary
- Research Site
-
Mosdos, Hungary
- Research Site
-
Mosonmagyarovar, Hungary
- Research Site
-
Pecs, Hungary
- Research Site
-
Szeged, Hungary
- Research Site
-
Torokbalint, Hungary
- Research Site
-
Ujronafj, Hungary
- Research Site
-
Zalaegerszeg, Hungary
- Research Site
-
Zalaegerszeg-Pozva, Hungary
- Research Site
-
-
-
-
-
India, India
- Research Site
-
Karnataka, India
- Research Site
-
Kolkata, India
- Research Site
-
Vellore, India
- Research Site
-
-
-
-
-
Beaumont Road, Ireland
- Research Site
-
Cork, Ireland
- Research Site
-
Dublin 7, Ireland
- Research Site
-
Dublin 8, Ireland
- Research Site
-
Elm Park, Ireland
- Research Site
-
-
Limerick
-
Dooradoyle, Limerick, Ireland
- Research Site
-
-
-
-
-
Daugavpils, Latvia
- Research Site
-
Liepaja, Latvia
- Research Site
-
Riga, Latvia
- Research Site
-
-
-
-
-
Kaunas, Lithuania
- Research Site
-
Vilnius, Lithuania
- Research Site
-
-
-
-
-
Kuala Lumpur, Malaysia
- Research Site
-
Nilai, Malaysia
- Research Site
-
Penang, Malaysia
- Research Site
-
-
-
-
-
Acapulco, Mexico
- Research Site
-
Durango, Mexico
- Research Site
-
Guadalajara, Mexico
- Research Site
-
Leon, Mexico
- Research Site
-
Mexico, Mexico
- Research Site
-
-
Coahuila
-
Torreon, Coahuila, Mexico
- Research Site
-
-
Jalisco
-
Guadalajara, Jalisco, Mexico
- Research Site
-
-
Neuvo Leon
-
Monterrey, Neuvo Leon, Mexico
- Research Site
-
-
Yucatan
-
Merida, Yucatan, Mexico
- Research Site
-
-
-
-
-
Alkmaar, Netherlands
- Research Site
-
Amsterdam, Netherlands
- Research Site
-
Enschede, Netherlands
- Research Site
-
Groningen, Netherlands
- Research Site
-
Leiden, Netherlands
- Research Site
-
Nieuwegein, Netherlands
- Research Site
-
Rotterdam, Netherlands
- Research Site
-
-
-
-
-
Alesund, Norway
- Research Site
-
Bergen, Norway
- Research Site
-
Gjettum, Norway
- Research Site
-
Hamar, Norway
- Research Site
-
Haugesund, Norway
- Research Site
-
Kristiansand, Norway
- Research Site
-
Nordbyhagen, Norway
- Research Site
-
Oslo, Norway
- Research Site
-
Skien, Norway
- Research Site
-
Stavanger, Norway
- Research Site
-
Tromso, Norway
- Research Site
-
Trondheim, Norway
- Research Site
-
-
-
-
-
Various Cities, Peru
- Research Site
-
-
-
-
-
Manila, Philippines
- Research Site
-
Pasig, Philippines
- Research Site
-
Quezon City, Philippines
- Research Site
-
-
-
-
-
Gdansk, Poland
- Research Site
-
Katowice, Poland
- Research Site
-
Krakow, Poland
- Research Site
-
Lodz, Poland
- Research Site
-
Poznan, Poland
- Research Site
-
Szczecin, Poland
- Research Site
-
Zabrze, Poland
- Research Site
-
-
-
-
-
Bucharest, Romania
- Research Site
-
Bucuresti, Romania
- Research Site
-
Cluj Napoca, Romania
- Research Site
-
Craiova, Romania
- Research Site
-
Iasi, Romania
- Research Site
-
Timisoara, Romania
- Research Site
-
-
-
-
-
Moscow, Russian Federation
- Research Site
-
St. Petersburg, Russian Federation
- Research Site
-
-
-
-
-
Singapore, Singapore
- Research Site
-
-
-
-
-
Bratislava, Slovakia
- Research Site
-
Dolny Kubin, Slovakia
- Research Site
-
Jilina, Slovakia
- Research Site
-
Kojice, Slovakia
- Research Site
-
Martin, Slovakia
- Research Site
-
Michalovce, Slovakia
- Research Site
-
Nitra, Slovakia
- Research Site
-
Nitra-Zobor, Slovakia
- Research Site
-
Nove Zamky, Slovakia
- Research Site
-
Poprad, Slovakia
- Research Site
-
Poprad - Kvetnica, Slovakia
- Research Site
-
Prejov, Slovakia
- Research Site
-
Trnava, Slovakia
- Research Site
-
-
-
-
-
Goteborg, Sweden
- Research Site
-
Huddinge, Sweden
- Research Site
-
Jonkoping, Sweden
- Research Site
-
Karlstad, Sweden
- Research Site
-
Linkoping, Sweden
- Research Site
-
Lund, Sweden
- Research Site
-
Stockholm, Sweden
- Research Site
-
Uppsala, Sweden
- Research Site
-
-
Vastmanlands Lan
-
Vasteras, Vastmanlands Lan, Sweden
- Research Site
-
-
-
-
-
Kaohsiung, Taiwan
- Research Site
-
Taichung, Taiwan
- Research Site
-
Tainan, Taiwan
- Research Site
-
Taipei, Taiwan
- Research Site
-
Tao-Yuan, Taiwan
- Research Site
-
-
Taipei
-
Pan-Chiao, Taipei, Taiwan
- Research Site
-
-
-
-
-
Bangkok, Thailand
- Research Site
-
Chiang Mai, Thailand
- Research Site
-
-
-
-
-
Ankara, Turkey
- Research Site
-
Istanbul, Turkey
- Research Site
-
Izmir, Turkey
- Research Site
-
-
-
-
-
Various Cities, Ukraine
- Research Site
-
-
-
-
-
Aberdeen, United Kingdom
- Research Site
-
Birmingham, United Kingdom
- Research Site
-
Bradford, United Kingdom
- Research Site
-
Brighton, United Kingdom
- Research Site
-
Coventry, United Kingdom
- Research Site
-
Dundee, United Kingdom
- Research Site
-
Essex, United Kingdom
- Research Site
-
Glasgow, United Kingdom
- Research Site
-
Guildford, United Kingdom
- Research Site
-
Gwynedd, United Kingdom
- Research Site
-
Harrogate, United Kingdom
- Research Site
-
Huddersfield, United Kingdom
- Research Site
-
Hull, United Kingdom
- Research Site
-
Lancaster, United Kingdom
- Research Site
-
Leicester, United Kingdom
- Research Site
-
Liverpool, United Kingdom
- Research Site
-
London, United Kingdom
- Research Site
-
Manchester, United Kingdom
- Research Site
-
Newcastle-upon-Tyne, United Kingdom
- Research Site
-
Nottingham, United Kingdom
- Research Site
-
Oxford, United Kingdom
- Research Site
-
Reading, United Kingdom
- Research Site
-
Southampton, United Kingdom
- Research Site
-
Swansea, United Kingdom
- Research Site
-
Wolverhampton, United Kingdom
- Research Site
-
York, United Kingdom
- Research Site
-
-
Cambrideshire
-
Cambridge, Cambrideshire, United Kingdom
- Research Site
-
-
Devon
-
Exeter, Devon, United Kingdom
- Research Site
-
-
Essex
-
Colchester, Essex, United Kingdom
- Research Site
-
Romford, Essex, United Kingdom
- Research Site
-
-
Great Yarmouth
-
Gorleston, Great Yarmouth, United Kingdom
- Research Site
-
-
Lanc
-
Fulwood, Lanc, United Kingdom
- Research Site
-
-
Norfolk
-
Norwich, Norfolk, United Kingdom
- Research Site
-
-
Northamptonshire
-
Nottingham, Northamptonshire, United Kingdom
- Research Site
-
-
Northern Ireland
-
Belfast, Northern Ireland, United Kingdom
- Research Site
-
-
West Midlands
-
Birmingham, West Midlands, United Kingdom
- Research Site
-
-
-
-
-
Various Cities, Venezuela
- Research Site
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
· Life expectancy of at least 8 weeks.
- Histologically or cytologically confirmed non-small cell bronchogenic carcinoma: adenocarcinoma (including bronchoalveolar), squamous cell carcinoma, large cell carcinoma or mixed (adenocarcinoma and squamous) or undifferentiated carcinoma
- Not suitable for chemotherapy
- WHO Performance status 0,1, 2 or 3
Exclusion Criteria:
- Newly diagnosed CNS mets
- Less than 1 week since completion of prior radiotherapy or persistence of any radiotherapy related toxicity
- ALT/AST greater than 5 x upper limit of normal
- ANC less than 1.0 x 109/L or platelets less than 100 x 109/L
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
|---|
|
The primary objective of this study is to compare overall survival for ZD1839 plus best supportive care versus placebo plus best supportive care
|
Secondary Outcome Measures
Outcome Measure |
|---|
|
· ZD1839 + BSC versus Placebo + BSC in terms of time to treatment failure
|
|
· ZD1839 + BSC versus Placebo + BSC in terms of investigator assessed overall
|
|
· objective tumour response (CR + PR)
|
|
· ZD1839 + BSC versus Placebo + BSC in terms of tolerability
|
|
· ZD1839 + BSC versus Placebo + BSC in terms of quality of life changes
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: AstraZeneca Oncology Medical Science Direction, AstraZeneca
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2003
Study Completion (Actual)
April 1, 2005
Study Registration Dates
First Submitted
October 19, 2005
First Submitted That Met QC Criteria
October 20, 2005
First Posted (Estimate)
October 21, 2005
Study Record Updates
Last Update Posted (Estimate)
April 23, 2009
Last Update Submitted That Met QC Criteria
April 22, 2009
Last Verified
April 1, 2009
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1839IL/0709
- ISEL
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on NSCLC
-
Shanghai Henlius BiotechCompleted
-
The Netherlands Cancer InstituteEnrolling by invitation
-
Centre Oscar LambretUniversity Hospital, LilleTerminated
-
Suzhou Zelgen Biopharmaceuticals Co.,LtdCompleted
-
Bio-Thera SolutionsCompleted
-
Jiangsu Province Nanjing Brain HospitalRecruiting
-
TYK Medicines, IncRecruiting
-
Radboud University Medical CenterPfizer; ImaginAb, Inc.; University Hospital TuebingenNot yet recruitingNSCLCGermany, Netherlands
-
Beta Pharma, Inc.Completed
Clinical Trials on Gefitinib
-
Sun Yat-sen UniversityUnknown
-
Qilu Pharmaceutical Co., Ltd.UnknownNon-small-cell Lung CancerChina
-
Sun Yat-sen UniversityWu Jieping Medical FoundationCompletedNon-small Cell Lung CancerChina
-
Jiangsu Famous Medical Technology Co., Ltd.UnknownNon-small Cell Lung Cancer
-
AstraZenecaCompletedNeoplasms, Squamous CellUnited States, Czech Republic, Poland, Germany, Belgium, Taiwan, India, Serbia
-
Anhui Medical UniversityUnknownSelf Efficacy | Drug ToxicityChina
-
NCIC Clinical Trials GroupCompletedProstate CancerCanada
-
University of Maryland, BaltimoreNational Cancer Institute (NCI); University of Maryland Greenebaum Cancer CenterCompleted
-
Samsung Medical CenterUnknownNon-small Cell Lung CancerKorea, Republic of
-
Gynecologic Oncology GroupNational Cancer Institute (NCI)CompletedOvarian Cancer | Primary Peritoneal Cavity CancerUnited States, Canada, United Kingdom, Australia