Phase II Iressa & Carbo/Gem in NSCLC

• Status: Completed
• Trial end date: 2008-06-01
• Target enrollment: 0
• Participant gender: All

Summary

The primary objective is to demonstrate in chemotherapy naïve patients with advanced (Stage IIIB or IV) NSCLC and ECOG PS 2 non-inferiority in progression free survival (PFS) for ZD1839 compared to gemcitabine/carboplatin.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AstraZeneca
• Treatments: Carboplatin; Gefitinib; Gemcitabine

Criteria

Inclusion Criteria:

• Advanced Non Small cell Lung Cell Lung cancer

• Never received chemotherapy

• Up and about 50% of waking hours

Exclusion Criteria:

• Spread of lung cancer to the brain

• Low level of white blood cells

• Radiotherapy within 4 weeks

Patients were entered to this study, initiated in 2004, before the significance of predictive factors such as smoking history, adenocarcinoma histology and mutation status was described.