Trial Information
A Randomized, Open-Label Phase II Study Of ZD1839 (IRESSA™) Versus Gemcitabine And Carboplatin In Chemotherapy-Naive Patients With Advanced (Stage IIIB OR IV) Non-Small Cell Lung Cancer And ECOG Performance Status 2
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.
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Progression Free Survival (PFS)
Outcome Time Frame:
Date of randomization to earliest date of objective disease progression
Safety Issue:
No
Principal Investigator
AstraZeneca Canada Oncology Medical Director, MD
Investigator Role:
Study Director
Investigator Affiliation:
AstraZeneca
Authority:
Canada: Health Canada
Study ID:
1839IL/0551
NCT ID:
NCT00264498
Start Date:
October 2004
Completion Date:
June 2008
Related Keywords:
- Carcinoma, Non-Small-Cell Lung
- Non-Small-Cell Lung Cancer
- NSCLC
- Lung Cancer
- Carcinoma
- Carcinoma, Non-Small-Cell Lung
- Lung Neoplasms