Non Small Cell Lung CarcinomaPhase 3NCT00234468
Iressa vs Placebo as Maintenance Therapy in Locally Advanced NSCLC
A Phase 3 study testing Iressa (Gefitinib) in people with Non Small Cell Lung Carcinoma, run by AstraZeneca at 32 sites in Italy.
Trial summary
The aim of the study if to determine if Iressa can prolong the period of time without any disease worsening (Time to progression) in patients previously treated with combined therapy such as surgery and chemotherapy with or without radiotherapy or chemotherapy and radiotherapy Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non Small Cell Lung Carcinoma
- What is being tested?
- Iressa (Gefitinib)
- How many people
- 490 participants
- Where
- 32 sitesItaly
- Study dates
- Jan 2004to Aug 2007
- 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
- Histologically Confirmed Non Small Cell Lung Cancer.
- Locally advanced disease previously treated with combined therapy (chemotherapy and surgery with or without radiotherapy, or chemotherapy and radiotherapy).
- Chemotherapy with regimens containing cisplatin or carboplatin is mandatory
- Response to combined therapy
Who cannot join
- No previous treatment with ZD1839 or any other EGFR-targeted therapy
- No progressive disease after combined therapy for locally advanced NSCLC
- No presence of metastatic disease
- No other co-existing malignancies or malignancies diagnosed within the last 5 years with the exception of basal cell carcinoma or cervical cancer in situ
- Any unresolved chronic toxicity from previous anticancer therapy.
Trial locations and contacts
32 sites in 1 country.
32 sites in 1 country
Italy32 sites
Research Site
Avellino
Research Site
Bergamo
Research Site
Bologna
Research Site
Cagliari
Research Site
Campobasso
Research Site
Catania
Research Site
Catanzaro
Research Site
Chieti
Research Site
Cosenza
Research Site
Della Fratte
Research Site
Emilia
Research Site
Fano
Research Site
Florence
Research Site
Forlì
Research Site
Frattamaggiore
Research Site
Livorno
Research Site
Messina
Research Site
Milan
Research Site
Naples
Research Site
Novara
Research Site
Orbassano
Research Site
Padova
Research Site
Palermo
Research Site
Pavia
Research Site
Potenza
Research Site
Ravenna
Research Site
Rimini
Research Site
Roma
Research Site
San Giovanni Rotondo
Research Site
Sassari
Research Site
Taormina
Research Site
Venezia-Mestre
About this study
Official title: A Phase III, Double-Blind, Randomised Study Comparing ZD1839 (IressaTM) Versus Placebo As Maintenance Therapy In Subjects With Locally Advanced Stage III Non-Small Cell Lung Cancer (NSCLC) After Combined Modality Therapy
The aim of the study if to determine if Iressa can prolong the period of time without any disease worsening (Time to progression) in patients previously treated with combined therapy such as surgery and chemotherapy with or without radiotherapy or chemotherapy and radiotherapy
- Conditions
- Non Small Cell Lung Carcinoma
- Being tested
- Iressa (Gefitinib)
- Keywords
- Locally Advanced Non Small Cell Lung Cancer (Stage IIIA and IIIB)
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Iressa (Gefitinib)Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to progression (2 years after Last patient in)
Secondary outcomes (2)
Modalities of relapse or progression (2 years after Last patient in)
Overall survival (2 years after Last patient in)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2005 (estimated)
- Study startJan 2004
- Study completionAug 2007
Why it stopped: Closed due to insufficient recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 490 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Lucio Crino, MD, Principal investigator, Bologna Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00234468
- Sponsor's protocol ID
- 1839IL/0126
- Status last verified
- May 2011
- First submitted
- 5 Oct 2005
- Last updated
- 20 May 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III, Double-Blind, Randomised Study Comparing ZD1839 (IressaTM) Versus Placebo As Maintenance Therapy In Subjects With Locally Advanced Stage III Non-Small Cell Lung Cancer (NSCLC) After Combined Modality Therapy
- ClinicalTrials.gov ID
- NCT00234468
- Acronym / sponsor ID
- 1839IL/0126
- Conditions
- Non Small Cell Lung Carcinoma
- Keywords
- Locally Advanced Non Small Cell Lung Cancer (Stage IIIA and IIIB)
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Closed due to insufficient recruitment
- Enrolment
- 490 participants (estimated)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Jan 2004
- Study completion
- Aug 2007 (actual)
- First posted
- 7 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.
The aim of the study if to determine if Iressa can prolong the period of time without any disease worsening (Time to progression) in patients previously treated with combined therapy such as surgery and chemotherapy with or without radiotherapy or chemotherapy and radiotherapy
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)
- Histologically Confirmed Non Small Cell Lung Cancer.
- Locally advanced disease previously treated with combined therapy (chemotherapy and surgery with or without radiotherapy, or chemotherapy and radiotherapy).
- Chemotherapy with regimens containing cisplatin or carboplatin is mandatory
- Response to combined therapy
Key exclusion criteria (5 listed)
- No previous treatment with ZD1839 or any other EGFR-targeted therapy
- No progressive disease after combined therapy for locally advanced NSCLC
- No presence of metastatic disease
- No other co-existing malignancies or malignancies diagnosed within the last 5 years with the exception of basal cell carcinoma or cervical cancer in situ
- Any unresolved chronic toxicity from previous anticancer therapy.
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 |
|---|---|---|
| Iressa (Gefitinib) | Drug | – |
Primary outcome
Time to progression (2 years after Last patient in)
2 secondary outcomes
Modalities of relapse or progression (2 years after Last patient in)
Overall survival (2 years after Last patient in)
Results and safety
The study was stopped early (reason given: Closed due to insufficient recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2011.
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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.
Lucio Crino, MD principal investigator
Bologna Italy
32 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Iressa (Gefitinib) in people with Non Small Cell Lung Carcinoma, run by AstraZeneca at 32 sites in Italy.
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: stopped early, as of the sponsor's last update on 20 May 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 32 sites in Italy. 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 was stopped early (reason given: Closed due to insufficient recruitment). Results are not available in the source record.
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?
Time to progression (2 years after Last patient in). 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 20 May 2011.