Phase II Iressa Versus Vinorelbine (INVITE)
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|ClinicalTrials.gov Identifier: NCT00256711|
Recruitment Status : Completed
First Posted : November 22, 2005
Last Update Posted : April 23, 2009
|Condition or disease||Intervention/treatment||Phase|
|Non-Small-Cell Lung Carcinoma||Drug: Gefitinib Drug: Vinorelbine||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||192 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||July 2004|
|Actual Study Completion Date :||February 2006|
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00256711
|Study Director:||AstraZeneca Iressa Medical Science Director, MD||AstraZeneca|