NSCLCPhase 3NCT00242801

Iressa vs Best Supportive Care - 2nd/3rd Line Survival Study

A Phase 3 study testing Gefitinib in people with NSCLC, run by AstraZeneca at 211 sites in 32 countries.

Completed

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

Trial summary

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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: NSCLC
What is being tested?: Gefitinib
How many people: 1,692 participants
Where: 211 sitesin 32 countries
Study dates: Jul 2003to Apr 2005
Phase: Phase 3
Are there results?: None posted in the registry

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

· 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

Who cannot join

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

Trial locations and contacts

211 sites in 32 countries.

Country

City, postcode or hospital

211 sites in 32 countries

United Kingdom36 sites

Research Site
Aberdeen
Research Site
Belfast, Northern Ireland
Research Site
Birmingham, West Midlands
Research Site
Birmingham
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Bradford
Research Site
Brighton
Research Site
Cambridge, Cambrideshire
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Colchester, Essex
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Coventry
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Dundee
Research Site
Essex
Research Site
Exeter, Devon
Research Site
Fulwood, Lanc
Research Site
Glasgow
Research Site
Gorleston-on-Sea, Great Yarmouth
Research Site
Guildford
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Gwynedd
Research Site
Harrogate
Research Site
Huddersfield
Research Site
Hull
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Lancaster
Research Site
Leicester
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Liverpool
Research Site
London
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Manchester
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Newcastle upon Tyne
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Norwich, Norfolk
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Nottingham, Northamptonshire
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Nottingham
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Oxford
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Reading
Research Site
Romford, Essex
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Southampton
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Swansea
Research Site
Wolverhampton
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York

Other trials in United Kingdom

Germany14 sites

Research Site
Bad Segeberg, Schleswig-Holstein
Research Site
Frankfurt
Research Site
Frankfurt am Main, Hesse
Research Site
Freiburg im Breisgau, Baden-Wurttemberg
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Freiburg im Breisgau
Research Site
Gauting
Research Site
Grobhansdorf
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Hamburg
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Heidelberg, Baden-Wurttemberg
Research Site
Heidelberg
Research Site
Hemer
Research Site
Muchen, Bavaria
Research Site
Münster, North Rhine-Westphalia
Research Site
Mutzschen

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Slovakia13 sites

Research Site
Bratislava
Research Site
Dolný Kubín
Research Site
Kojice
Research Site
Martin
Research Site
Michalovce
Research Site
Nitra
Research Site
Nitra-Zobor
Research Site
Nové Zámky
Research Site
Poprad
Research Site
Poprad - Kvetnica
Research Site
Prejov
Research Site
Trnava
Research Site
Žilina

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Australia12 sites

Research Site
Ashford, South Australia
Research Site
Chermside, Queensland
Research Site
Concord, New South Wales
Research Site
Melbourne, Victoria
Research Site
Parkville, Victoria
Research Site
Potts Point, New South Wales
Research Site
Prahran, Victoria
Research Site
South Brisbane, Queensland
Research Site
St Leonards, New South Wales
Research Site
Wodonga, Victoria
Research Site
Woodville, South Australia
Research Site
Woodville South

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Canada12 sites

Research Site
Calgary, Alberta
Research Site
Edmonton, Alberta
Research Site
Greater Sudbury, Ontario
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Laval, Quebec
Research Site
Mississauga, Ontario
Research Site
Monoton, New Brunswick
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Montreal, Quebec
Research Site
Newmarket, Ontario
Research Site
Saint Catherines, Ontario
Research Site
Ste-Foy, Quebec
Research Site
Toronto, Ontario
Research Site
York, Ontario

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Hungary12 sites

Research Site
Budapest
Research Site
Debrecen
Research Site
Deszk
Research Site
Kecskemét
Research Site
Mosdós
Research Site
Mosonmagyaróvár
Research Site
Pécs
Research Site
Szeged
Research Site
Törökbálint
Research Site
Ujronafj
Research Site
Zalaegerszeg
Research Site
Zalaegerszeg-Pozva

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Norway12 sites

Research Site
Ålesund
Research Site
Bergen
Research Site
Gjettum
Research Site
Hamar
Research Site
Haugesund
Research Site
Kristiansand
Research Site
Nordbyhagen
Research Site
Oslo
Research Site
Skien
Research Site
Stavanger
Research Site
Tromsø
Research Site
Trondheim

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Mexico9 sites

Research Site
Acapulco
Research Site
Durango, Durango
Research Site
Guadalajara, Jalisco
Research Site
Guadalajara
Research Site
León
Research Site
Mérida, Yucatán
Research Site
México
Research Site
Monterrey, Neuvo Leon
Research Site
Torreón, Coahuila

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Sweden9 sites

Research Site
Gothenburg
Research Site
Huddinge
Research Site
Jönköping
Research Site
Karlstad
Research Site
Linköping
Research Site
Lund
Research Site
Stockholm
Research Site
Uppsala
Research Site
Västerås, Västmanland County

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Argentina7 sites

Research Site
Bahía Blanca
Research Site
Buenos Aires
Research Site
Capital Federal, Buenos Aires
Research Site
La Plata
Research Site
Mar del Plata
Research Site
Rosario
Research Site
Santa Fe

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Netherlands7 sites

Research Site
Alkmaar
Research Site
Amsterdam
Research Site
Enschede
Research Site
Groningen
Research Site
Leiden
Research Site
Nieuwegein
Research Site
Rotterdam

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Poland7 sites

Research Site
Gdansk
Research Site
Katowice
Research Site
Krakow
Research Site
Lodz
Research Site
Poznan
Research Site
Szczecin
Research Site
Zabrze

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Brazil6 sites

Research Site
Belo Horizonte, Minas Gerais
Research Site
Fortaleza, Ceará
Research Site
Porto Alegre, Rio Grande do Sul
Research Site
Rio de Janeiro, Rio de Janeiro
Research Site
São Paulo, São Paulo
Research Site
Sorocaba, São Paulo

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Bulgaria6 sites

Research Site
Pleven
Research Site
Plovdiv
Research Site
Sofia
Research Site
Stara Zagora
Research Site
Varna
Research Site
Veliko Tarnovo

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Taiwan6 sites

Research Site
Banqiao District, Taipei
Research Site
Kaohsiung City
Research Site
Taichung
Research Site
Tainan
Research Site
Taipei
Research Site
Taoyuan

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Ireland5 sites

Research Site
Beaumont Road
Research Site
Cork, Cork
Research Site
Dooradoyle, Limerick
Research Site
Dublin
Research Site
Elm Park

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Romania5 sites

Research Site
Bucharest
Research Site
Cluj-Napoca
Research Site
Craiova
Research Site
Iași
Research Site
Timișoara

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Greece4 sites

Research Site
Athens
Research Site
Heraklion
Research Site
Marousi
Research Site
Thessaloniki

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India4 sites

Research Site
India
Research Site
Karnataka
Research Site
Kolkata
Research Site
Vellore

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Latvia3 sites

Research Site
Daugavpils
Research Site
Liepāja
Research Site
Riga

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Malaysia3 sites

Research Site
George Town
Research Site
Kampung Baharu Nilai
Research Site
Kuala Lumpur

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Philippines3 sites

Research Site
Manila
Research Site
Pasig
Research Site
Quezon City

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Turkey (Türkiye)3 sites

Research Site
Ankara
Research Site
Istanbul
Research Site
Izmir

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Estonia2 sites

Research Site
Talinn
Research Site
Tartu

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Lithuania2 sites

Research Site
Kaunas
Research Site
Vilnius

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Russia2 sites

Research Site
Moscow
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Saint Petersburg

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Thailand2 sites

Research Site
Bangkok
Research Site
Chiang Mai

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Chile1 site

Research Site
Various Cities

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Peru1 site

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Various Cities

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Singapore1 site

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Singapore

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Ukraine1 site

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Various Cities

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Venezuela1 site

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About this study

Official title: 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

Conditions: NSCLC
Being tested: Gefitinib

What participants receive

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

GefitinibDrug

What is being measured

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

The primary objective of this study is to compare overall survival for ZD1839 plus best supportive care versus placebo plus best supportive care

Secondary outcomes (5)

· 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

Timeline

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

Jul 2003Apr 2005

First posted21 Oct 2005 (estimated)
Study startJul 2003
Study completionApr 2005

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for NSCLCStudies of the same condition, open and under way.
More trials run by AstraZenecaThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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: Double blind
Enrolment: 1,692 participants

IDs, dates and publications

ClinicalTrials.gov ID: NCT00242801
Sponsor's protocol ID: 1839IL/0709
Other IDs: ISEL
Status last verified: Apr 2009
First submitted: 19 Oct 2005
Last updated: 23 Apr 2009
Results posted: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 3
A Study to Learn About the Study Medicine Called PF-08046054/SGN-PDL1V Versus Docetaxel in Adult Participants With Previously-Treated Programmed Cell Death Ligand 1 (PD-L1) Positive Non-Small-Cell Lung Cancer (NSCLC)
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All NSCLC trials

Study at a glance

From the registry record, last updated by the sponsor on 23 Apr 2009. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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
ClinicalTrials.gov ID: NCT00242801
Acronym / sponsor ID: 1839IL/0709
Conditions: NSCLC
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 1,692 participants
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Study start: Jul 2003
Study completion: Apr 2005 (actual)
First posted: 21 Oct 2005 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

· Life expectancy of at least 8 weeks.

Key exclusion criteria (4 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Gefitinib	Drug	–

Primary outcome

The primary objective of this study is to compare overall survival for ZD1839 plus best supportive care versus placebo plus best supportive care

5 secondary outcomes

· 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

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2009.

Related trials for NSCLC

RecruitingPhase 3
A Study to Learn About the Study Medicine Called PF-08046054/SGN-PDL1V Versus Docetaxel in Adult Participants With Previously-Treated Programmed Cell Death Ligand 1 (PD-L1) Positive Non-Small-Cell Lung Cancer (NSCLC)
Non-small Cell Carcinoma, Non-Small Cell Lung Cancer Metastatic
RecruitingObservational study
Real-World Outcomes of Sevabertinib in HER2-Mutant Advanced NSCLC: A Bidirectional Cohort Study
HER2-mutant Advanced Non-Small Cell Lung Cancer
Active, not recruitingPhase 2
CAN-2409 Plus Prodrug With Standard of Care Immune Checkpoint Inhibitor for Stage III/IV NSCLC
Non Small Cell Lung Cancer
RecruitingPhase 2
Hotspot Stereotactic Ablative Radiotherapy Versus Traditional Stereotactic Ablative Radiotherapy for the Treatment of Early-Stage Non-Small Cell Lung Cancer
Early Stage Lung Non-Small Cell Carcinoma, Stage I Lung Cancer AJCC v8
RecruitingObservational study
Biospecimen Procurement for Center for Immuno-Oncology Immunotherapy Protocols
Multiple Myeloma, Lymphoma, Non-Hodgkin

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

AstraZeneca Oncology Medical Science Direction study director

AstraZeneca

211 sites in 32 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Gefitinib in people with NSCLC, run by AstraZeneca at 211 sites in 32 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 4 inclusion and 4 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 23 Apr 2009. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 211 sites in United Kingdom, Germany, Slovakia, Australia, Canada and 27 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. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

The primary objective of this study is to compare overall survival for ZD1839 plus best supportive care versus placebo plus best supportive care. 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 NCT00242801.

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 23 Apr 2009.