A randomised, open -label, parallel-group, international, multicenter phase III study of oral ZD1839 (IRESSA) versus intravenous docetaxel (Taxotere) in patients with locally advanced or metastatic recurrent non small cell lung cancer who have previously received platinum based chemotherapy - INTEREST
- Conditions
- ocally advanced of metastatic recurrent non-small cell lung cancer
- Registration Number
- EUCTR2004-002943-28-EE
- Lead Sponsor
- AstraZeneca AB
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 1440
Inclusion Criteria
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
Not provided
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To compare overall survival between ZD1839 and docetaxel;Secondary Objective: 1. To compare TTP between ZD1839 and docetaxel<br>2. to compare progression-free rates a 4 months and 6 months between ZD1839 and docetaxel<br>3. to compare the overall objective tumor response rate between ZD1839 and docetaxel<br>4. to compare patient-reported functionally (PRF) and QoL between ZD1839 and docetaxel<br>5. to compare safety and tolerability of ZD1839 and docetaxel;Primary end point(s):
- Secondary Outcome Measures
Name Time Method