NSCLCPhase 2/3INSTEPNCT00259064
Iressa v BSC (Best Supportive Care) in First Line NSCLC
A Phase 2/3 study testing Gefitinib in people with NSCLC, run by AstraZeneca at 36 sites in 5 countries.
Trial summary
The purpose of the study is to determine if the addition of Iressa to Best Supportive Care treatment will increase the progression free survival of chemo-naïve, poor performance status patients, with stage IIIB or IV NSCLC. Read more about this study
- Who is it for?
- Ages 18 to 130 years
- Conditions the study is for
- NSCLC
- What is being tested?
- Gefitinib
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 216 participants
- Where
- 36 sitesin 5 countries
- Study dates
- Sep 2004to Apr 2016
- Phase
- Phase 2/3
- 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 to 130 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically or cytologically confirmed NSCLC
- NSCLC - locally advanced (Stage IIIB) or metastatic (stage IV) disease, not amenable to curative surgery or radiotherapy
- Not suitable for chemotherapy
- WHO Performance status 2 or 3
Who cannot join
- Newly diagnosed CNS mets
- Less than 4 weeks since completion of radiotherapy or persistence of any radiotherapy related toxicity
- Other co-existing malignancies
- 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
36 sites in 5 countries.
36 sites in 5 countries
Canada18 sites
Research Site
Barrie, Ontario
Research Site
Calgary, Alberta
Research Site
Edmonton, Alberta
Research Site
Halifax, Nova Scotia
Research Site
Hamilton, Ontario
Research Site
Kelowna, British Columbia
Research Site
Kingston, Ontario
Research Site
London, Ontario
Research Site
Mississauga, Ontario
Research Site
Moncton, New Brunswick
Research Site
Newmarket, Ontario
Research Site
Oshawa, Ontario
Research Site
Ottawa, Ontario
Research Site
Sault Ste. Marie, Ontario
Research Site
Surrey, British Columbia
Research Site
Thunder Bay, Ontario
Research Site
Toronto, Ontario
Research Site
Winnipeg, Manitoba
Australia7 sites
Research Site
Bedford Park
Research Site
Chermside
Research Site
Concord
Research Site
Melbourne
Research Site
Newcastle
Research Site
Prahran
Research Site
Randwick
Netherlands5 sites
Research Site
's-Hertogenbosch
Research Site
Amsterdam
Research Site
Eindhoven
Research Site
The Hague
Research Site
Zutphen
United Kingdom5 sites
Research Site
Abergavenny
Research Site
Birmingham
Research Site
Cardiff
Research Site
Leeds
Research Site
Wolverhampton
About this study
Official title: A Phase II Multicentre Randomised, Parallel Group, Double-Blind, Placebo-Controlled Study of ZD1839 (IRESSATM) (250MG Tablet) Plus Best Supportive Care (BSC) Versus Placebo Plus BSC in Chemotherapy-Naive Patients With Advanced (Stage IIIB or IV) Non-Small Cell Lung Cancer (NSCLC) and Poor Performance Status
The purpose of the study is to determine if the addition of Iressa to Best Supportive Care treatment will increase the progression free survival of chemo-naïve, poor performance status patients, with stage IIIB or IV NSCLC.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GefitinibDrug
PlaceboOther
| Study group | Role | What they receive |
|---|---|---|
| Gefitinib | Experimental | ZD1839 + BSC (best supportive care) Receives: Drug: Gefitinib |
| Placebo | Placebo comparator | Placebo + BSC (best supportive care) Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
To compare Iressa v best supportive care in terms of progression free survival
Measured: Progression-free survival
Secondary outcomes (4)
To compare Iressa v best supportive care in terms of objective tumour response rate
Measured: Overall objective tumour response rate (CR and PR) according to the RECIST criteria
To compare Iressa v best supportive care in terms of overall survival
Measured: Time to death
To compare Iressa v best supportive care in terms of quality of life
Measured: Improvement in patient-reported functionality as measured by trial outcome index, comprised of the physical and functional well being sections and LCS of FACT-L and quality of life measured by the FACT-L total score
To compare Iressa v best supportive care in terms of tolerability
Measured: Adverse event profile (type, frequency and severity of adverse events); laboratory parameters and vital signs
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2005 (estimated)
- Study startSep 2004
- Primary completionFeb 2007
- Study completionApr 2016
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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 216 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- AstraZeneca Iressa Medical Science Director, MD, Study director, AstraZeneca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00259064
- Sponsor's protocol ID
- 1839IL/0711
- Other IDs
- D7913C00711
- Acronym
- INSTEP
- Status last verified
- May 2016
- First submitted
- 25 Nov 2005
- Last updated
- 2 Jun 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Multicentre Randomised, Parallel Group, Double-Blind, Placebo-Controlled Study of ZD1839 (IRESSATM) (250MG Tablet) Plus Best Supportive Care (BSC) Versus Placebo Plus BSC in Chemotherapy-Naive Patients With Advanced (Stage IIIB or IV) Non-Small Cell Lung Cancer (NSCLC) and Poor Performance Status
- ClinicalTrials.gov ID
- NCT00259064
- Acronym / sponsor ID
- INSTEP / 1839IL/0711
- Conditions
- NSCLC
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 216 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Sep 2004
- Primary completion
- Feb 2007 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 29 Nov 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.
The purpose of the study is to determine if the addition of Iressa to Best Supportive Care treatment will increase the progression free survival of chemo-naïve, poor performance status patients, with stage IIIB or IV NSCLC.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Gefitinib | Experimental | Drug: GefitinibZD1839 + BSC (best supportive care) |
| Placebo | Placebo comparator | Other: PlaceboPlacebo + BSC (best supportive care) |
Who may qualify
- Ages
- 18 to 130 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Histologically or cytologically confirmed NSCLC
- NSCLC - locally advanced (Stage IIIB) or metastatic (stage IV) disease, not amenable to curative surgery or radiotherapy
- Not suitable for chemotherapy
- WHO Performance status 2 or 3
Key exclusion criteria (5 listed)
- Newly diagnosed CNS mets
- Less than 4 weeks since completion of radiotherapy or persistence of any radiotherapy related toxicity
- Other co-existing malignancies
- 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 | Gefitinib |
| Placebo | Other | Placebo |
Primary outcome
To compare Iressa v best supportive care in terms of progression free survival
Time frame: Progression-free survival
4 secondary outcomes
To compare Iressa v best supportive care in terms of objective tumour response rate
Time frame: Overall objective tumour response rate (CR and PR) according to the RECIST criteria
To compare Iressa v best supportive care in terms of overall survival
Time frame: Time to death
To compare Iressa v best supportive care in terms of quality of life
Time frame: Improvement in patient-reported functionality as measured by trial outcome index, comprised of the physical and functional well being sections and LCS of FACT-L and quality of life measured by the FACT-L total score
To compare Iressa v best supportive care in terms of tolerability
Time frame: Adverse event profile (type, frequency and severity of adverse events); laboratory parameters and vital signs
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 2 Jun 2016.
- CSR-1839IL-0711.pdfLink provided by the sponsor.
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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 Iressa Medical Science Director, MD study director
AstraZeneca
36 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Gefitinib in people with NSCLC, run by AstraZeneca at 36 sites in 5 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 5 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 2 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 36 sites in Canada, Australia, Netherlands, United Kingdom, Czechia. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
To compare Iressa v best supportive care in terms of progression free survival (time frame: Progression-free survival). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Jun 2016.