Trial Information
A Randomised, Open Label, Parallel Group, Multi-Centre, Phase II Study of Progression Free Survival Comparing ZD1839 (IRESSA™) (250 MG Tablet) Versus Vinorelbine (30 MG/M2 Infusion) in Chemonaive, Elderly Patients With Locally Advanced (Stage IIIB) or Metastatic (Stage IV) NSCLC
Inclusion Criteria:
- Histologically confirmed NSCLC and willing to provide paraffin embedded tumour tissue
- NSCLC - locally advanced (Stage IIIB) or metastatic (stage IV) disease, not amenable
to curative surgery or radiotherapy chemonaïve, life expectancy of 12 weeks
- WHO Performance status <= 2
Exclusion Criteria:
- Newly diagnosed CNS metastases
- Less than 4 weeks since completion of radiotherapy or persistence of any radiotherapy
related toxicity.
- Hypersensitivity to ZD1839 or intravenous vinorelbine
- Prior treatment with EGFR inhibitors
- Other co-existing malignancies
- ALT/AST >2.5 x ULRR
- ANC < 2.0 x 10^9/L or platelets < 100 x 10^9/L
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
To compare ZD1839 and vinorelbine in terms of progression free survival
Principal Investigator
AstraZeneca Iressa Medical Science Director, MD
Investigator Role:
Study Director
Investigator Affiliation:
AstraZeneca
Authority:
Czech Republic: State Institute for Drug Control
Study ID:
D791AC00001
NCT ID:
NCT00256711
Start Date:
July 2004
Completion Date:
February 2006
Related Keywords:
- Non-Small-Cell Lung Carcinoma
- Locally advanced or metastatic NSCLC.
- Stage IIIb or Stage IV lung cancer
- Carcinoma
- Carcinoma, Non-Small-Cell Lung
- Lung Neoplasms