Iressa vs Best Supportive Care - 2nd/3rd Line Survival Study

• Status: Completed
• Trial end date: 2005-04-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AstraZeneca
• Treatments: Gefitinib

Criteria

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