Status:
COMPLETED
Iressa v BSC (Best Supportive Care) in First Line NSCLC
Lead Sponsor:
AstraZeneca
Conditions:
NSCLC
Eligibility:
All Genders
18-130 years
Phase:
PHASE2
PHASE3
Brief 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 ...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
September 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2016
Estimated Enrollment :
216 Patients enrolled
Trial Details
Trial ID
NCT00259064
Start Date
September 1 2004
End Date
April 1 2016
Last Update
June 2 2016
Active Locations (36)
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1
Research Site
Bedford Park, Australia
2
Research Site
Chermside, Australia
3
Research Site
Concord, Australia
4
Research Site
Melbourne, Australia