Phase II Iressa Versus Vinorelbine (INVITE)
This is a randomized, open label, parallel group, multi-centre, phase II study of progression free survival, comparing oral ZD1839 (IRESSA™) (250 mg tablet once daily) to vinorelbine 30 mg/m2 infusion on days 1 and 8 of a 21-day cycle) in chemonaïve, elderly patients with locally advanced (stage IIIB) or metastatic (stage IV) non-small cell lung cancer.
Non-Small-Cell Lung Carcinoma
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||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|
- To compare ZD1839 and vinorelbine in terms of progression free survival
- To compare ZD1839 and vinorelbine in terms of pulmonary symptom improvement weekly for 18 weeks.
- To compare ZD1839 and vinorelbine in terms of quality of life 3 weekly for 18 weeks then 6 weekly.
- To compare ZD1839 and vinorelbine in terms of adverse event profile continuous monitoring.
- To compare ZD1839 and vinorelbine in terms of overall objective tumour response rate (complete response and partial response) 6 weekly to progression.
- To compare ZD1839 and vinorelbine in terms of overall survival (time to death) continuous monitoring
|Study Start Date:||July 2004|
|Study Completion Date:||February 2006|
Show 56 Study Locations
|Study Director:||AstraZeneca Iressa Medical Science Director, MD||AstraZeneca|