Study identifier:D7913L00071
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
A Placebo-Controlled, Multicentre, Randomised, Parallel Group, trial to Assess the Efficacy, Safety and Tolerability of Gefitinib (Iressa® 250mg) as Maintenance Therapy in Locally Advanced or Metastatic (StageIIIB/IV) Non Small Cell Lung Cancer (NSCLC) Chinese Patients who HaveNot Experienced Disease Progression or Unacceptable Toxicity during Front Line Standard Platinum-Based Chemotherapy
Non-small cell lung cancer (NSCLC)
Phase 4
No
Gefitinib, Placebo
All
296
Interventional
18 Years +
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Treatment
Verified 01 Aug 2012 by AstraZeneca Pharmaceuticals
AstraZeneca Pharmaceuticals
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No locations available
Arms | Assigned Interventions |
---|---|
Experimental: gefitinib Gefitinib (Iressa® 250 mg) 1 tablet daily | Drug: Gefitinib Dose form: 250 mg/tablet; Route: oral; Frequency: 1 tablet per day; Duration: until to objective PD Other Name: Iressa |
Placebo Comparator: placebo placebo 1 tablet daily | Drug: Placebo To match Gefitinib |