Status:
TERMINATED
Iressa vs Placebo as Maintenance Therapy in Locally Advanced NSCLC
Lead Sponsor:
AstraZeneca
Conditions:
Non Small Cell Lung Carcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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 a...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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.
Key Trial Info
Start Date :
January 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2007
Estimated Enrollment :
490 Patients enrolled
Trial Details
Trial ID
NCT00234468
Start Date
January 1 2004
End Date
August 1 2007
Last Update
May 20 2011
Active Locations (32)
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1
Research Site
Avellino, Italy
2
Research Site
Bergamo, Italy
3
Research Site
Bologna, Italy
4
Research Site
Cagliari, Italy