Non-Small-Cell Lung CarcinomaPhase 2NCT00256711
Phase II Iressa Versus Vinorelbine (INVITE)
A Phase 2 study testing Gefitinib and Vinorelbine in people with Non-Small-Cell Lung Carcinoma, run by AstraZeneca at 55 sites in 10 countries.
Trial summary
This is a randomized, open label, parallel group, multi-centre, phase II study of progression free survival, comparing oral ZD1839 (IRESSA™) (250 mg tablet once daily) to vinorelbine 30 mg/m2 infusion on days 1 and 8 of a 21-day cycle) in chemonaïve, elderly patients with locally advanced (stage IIIB) or metastatic… Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Non-Small-Cell Lung Carcinoma
- What is being tested?
- Gefitinib and Vinorelbine
- How many people
- 192 participants
- Where
- 55 sitesin 10 countries
- Study dates
- Jul 2004to Feb 2006
- Phase
- Phase 2
- 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 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Histologically confirmed NSCLC and willing to provide paraffin embedded tumour tissue
- NSCLC - locally advanced (Stage IIIB) or metastatic (stage IV) disease, not amenable to curative surgery or radiotherapy chemonaïve, life expectancy of 12 weeks
- WHO Performance status <= 2
Who cannot join
- Newly diagnosed CNS metastases
- Less than 4 weeks since completion of radiotherapy or persistence of any radiotherapy related toxicity.
- Hypersensitivity to ZD1839 or intravenous vinorelbine
- Prior treatment with EGFR inhibitors
- Other co-existing malignancies
- ALT/AST >2.5 x ULRR
- ANC < 2.0 x 10^9/L or platelets < 100 x 10^9/L
Trial locations and contacts
55 sites in 10 countries.
55 sites in 10 countries
Italy12 sites
Research Site
Bergamo, BG
Research Site
Bologna, BO
Research Site
Catania, CT
Research Site
La Torretta, Ancona
Research Site
Melegnano, MI
Research Site
Milan, MI
Research Site
Modena, MO
Research Site
Naples
Research Site
Orbassano, TO
Research Site
Parma, PR
Research Site
Rozzano, MI
Research Site
Torino, TO
Germany10 sites
Research Site
Bad Segeberg, Schleswig-Holstein
Research Site
Berlin, State of Berlin
Research Site
Großhansdorf
Research Site
Halle
Research Site
Hamburg, Free and Hanseatic City of Hamburg
Research Site
Heidelberg, Baden-Wurttemberg
Research Site
Magdeburg, Saxony-Anhalt
Research Site
Mainz
Research Site
München, Bavaria
Research Site
Ulm, Baden-Wurttemberg
Czechia8 sites
Research Site
Hradec Králové
Research Site
Kutná Hora
Research Site
Olomouc
Research Site
Ostrava
Research Site
Ostrava - Poruba
Research Site
Pilsen
Research Site
Prague, CZ
Research Site
Ústí nad Labem, CZ
United Kingdom7 sites
Research Site
Aberdeen
Research Site
Birmingham, West Midlands
Research Site
Cambridge, Cambrideshire
Research Site
Dundee
Research Site
Glasgow
Research Site
Nottingham
Research Site
Sheffield
Australia5 sites
Research Site
Nedlands, Western Australia
Research Site
South Brisbane, Queensland
Research Site
St Leonards, New South Wales
Research Site
Victoria
Research Site
Westmead, New South Wales
Brazil4 sites
Research Site
Fortaleza, Ceará
Research Site
Goiânia, Goiás
Research Site
Rio de Janeiro, Rio de Janeiro
Research Site
São Paulo, São Paulo
France4 sites
Research Site
Marseille
Research Site
Montpellier
Research Site
Pierre-Bénite
Research Site
Vesoul
About this study
Official title: A Randomised, Open Label, Parallel Group, Multi-Centre, Phase II Study of Progression Free Survival Comparing ZD1839 (IRESSA™) (250 MG Tablet) Versus Vinorelbine (30 MG/M2 Infusion) in Chemonaive, Elderly Patients With Locally Advanced (Stage IIIB) or Metastatic (Stage IV) NSCLC
This is a randomized, open label, parallel group, multi-centre, phase II study of progression free survival, comparing oral ZD1839 (IRESSA™) (250 mg tablet once daily) to vinorelbine 30 mg/m2 infusion on days 1 and 8 of a 21-day cycle) in chemonaïve, elderly patients with locally advanced (stage IIIB) or metastatic (stage IV) non-small cell lung cancer.
- Conditions
- Non-Small-Cell Lung Carcinoma
- Being tested
- Gefitinib, Vinorelbine
- Keywords
- Locally advanced or metastatic NSCLC., Stage IIIb or Stage IV lung cancer
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GefitinibDrug
VinorelbineDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
To compare ZD1839 and vinorelbine in terms of progression free survival
Secondary outcomes (5)
To compare ZD1839 and vinorelbine in terms of pulmonary symptom improvement weekly for 18 weeks.
To compare ZD1839 and vinorelbine in terms of quality of life 3 weekly for 18 weeks then 6 weekly.
To compare ZD1839 and vinorelbine in terms of adverse event profile continuous monitoring.
To compare ZD1839 and vinorelbine in terms of overall objective tumour response rate (complete response and partial response) 6 weekly to progression.
To compare ZD1839 and vinorelbine in terms of overall survival (time to death) continuous monitoring
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2005 (estimated)
- Study startJul 2004
- Study completionFeb 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Non-Small-Cell Lung CarcinomaStudies 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 192 participants
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- AstraZeneca Iressa Medical Science Director, MD, Study director, AstraZeneca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00256711
- Sponsor's protocol ID
- D791AC00001
- Other IDs
- INVITE
- Status last verified
- Apr 2009
- First submitted
- 20 Nov 2005
- Last updated
- 23 Apr 2009
- Results posted
- No
Publications
Crino L, Cappuzzo F, Zatloukal P, Reck M, Pesek M, Thompson JC, Ford HE, Hirsch FR, Varella-Garcia M, Ghiorghiu S, Duffield EL, Armour AA, Speake G, Cullen M. Gefitinib versus vinorelbine in chemotherapy-naive elderly patients with advanced non-small-cell lung cancer (INVITE): a randomized, phase II study. J Clin Oncol. 2008 Sep 10;26(26):4253-60. doi: 10.1200/JCO.2007.15.0672.
PubMed 18779612
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 Randomised, Open Label, Parallel Group, Multi-Centre, Phase II Study of Progression Free Survival Comparing ZD1839 (IRESSA™) (250 MG Tablet) Versus Vinorelbine (30 MG/M2 Infusion) in Chemonaive, Elderly Patients With Locally Advanced (Stage IIIB) or Metastatic (Stage IV) NSCLC
- ClinicalTrials.gov ID
- NCT00256711
- Acronym / sponsor ID
- D791AC00001
- Conditions
- Non-Small-Cell Lung Carcinoma
- Keywords
- Locally advanced or metastatic NSCLC., Stage IIIb or Stage IV lung cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 192 participants
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Jul 2004
- Study completion
- Feb 2006 (actual)
- First posted
- 22 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.
This is a randomized, open label, parallel group, multi-centre, phase II study of progression free survival, comparing oral ZD1839 (IRESSA™) (250 mg tablet once daily) to vinorelbine 30 mg/m2 infusion on days 1 and 8 of a 21-day cycle) in chemonaïve, elderly patients with locally advanced (stage IIIB) or metastatic (stage IV) non-small cell lung cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- Histologically confirmed NSCLC and willing to provide paraffin embedded tumour tissue
- NSCLC - locally advanced (Stage IIIB) or metastatic (stage IV) disease, not amenable to curative surgery or radiotherapy chemonaïve, life expectancy of 12 weeks
- WHO Performance status <= 2
Key exclusion criteria (7 listed)
- Newly diagnosed CNS metastases
- Less than 4 weeks since completion of radiotherapy or persistence of any radiotherapy related toxicity.
- Hypersensitivity to ZD1839 or intravenous vinorelbine
- Prior treatment with EGFR inhibitors
- Other co-existing malignancies
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 | – |
| Vinorelbine | Drug | – |
Primary outcome
To compare ZD1839 and vinorelbine in terms of progression free survival
5 secondary outcomes
To compare ZD1839 and vinorelbine in terms of pulmonary symptom improvement weekly for 18 weeks.
To compare ZD1839 and vinorelbine in terms of quality of life 3 weekly for 18 weeks then 6 weekly.
To compare ZD1839 and vinorelbine in terms of adverse event profile continuous monitoring.
To compare ZD1839 and vinorelbine in terms of overall objective tumour response rate (complete response and partial response) 6 weekly to progression.
To compare ZD1839 and vinorelbine in terms of overall survival (time to death) continuous monitoring
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.
- Derived from this study: PubMed 18779612Crino L, Cappuzzo F, Zatloukal P, Reck M, Pesek M, Thompson JC, Ford HE, Hirsch FR, Varella-Garcia M, Ghiorghiu S, Duffield EL, Armour AA, Speake G, Cullen M. Gefitinib versus vinorelbine in chemotherapy-naive elderly patients with advanced non-small-cell lung cancer (INVITE): a randomized, phase II study. J Clin Oncol. 2008 Sep 10;26(26):4253-60. doi: 10.1200/JCO.2007.15.0672.
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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
55 sites in 10 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Gefitinib and Vinorelbine in people with Non-Small-Cell Lung Carcinoma, run by AstraZeneca at 55 sites in 10 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 3 inclusion and 7 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 55 sites in Italy, Germany, Czechia, United Kingdom, Australia and 5 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 ZD1839 and vinorelbine in terms of progression free survival. 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 NCT00256711, which also lists 1 linked publication.
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.