Iressa vs Best Supportive Care - 2nd/3rd Line Survival Study
Phase 3
Completed
- Conditions
- NSCLC
- Registration Number
- NCT00242801
- Lead Sponsor
- AstraZeneca
- Brief Summary
This study is being carried out to see if adding ZD1839 to other standard supportive care is more effective than standard supportive care alone for the treatment of patients with NSCLC whose disease has recurred after previous chemotherapy treatment.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1692
Inclusion Criteria
-
· Life expectancy of at least 8 weeks.
- Histologically or cytologically confirmed non-small cell bronchogenic carcinoma: adenocarcinoma (including bronchoalveolar), squamous cell carcinoma, large cell carcinoma or mixed (adenocarcinoma and squamous) or undifferentiated carcinoma
- Not suitable for chemotherapy
- WHO Performance status 0,1, 2 or 3
Exclusion Criteria
- Newly diagnosed CNS mets
- Less than 1 week since completion of prior radiotherapy or persistence of any radiotherapy related toxicity
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method The primary objective of this study is to compare overall survival for ZD1839 plus best supportive care versus placebo plus best supportive care
- Secondary Outcome Measures
Name Time Method · ZD1839 + BSC versus Placebo + BSC in terms of time to treatment failure · ZD1839 + BSC versus Placebo + BSC in terms of investigator assessed overall · objective tumour response (CR + PR) · ZD1839 + BSC versus Placebo + BSC in terms of tolerability · ZD1839 + BSC versus Placebo + BSC in terms of quality of life changes
Trial Locations
- Locations (1)
Research Site
🇻🇪Various Cities, Venezuela