Assess the Efficacy, Safety and Tolerability of Gefitinib (Iressa® 250mg) as Maintenance Therapy in Locally Advanced or Metastatic (Stage IIIB/IV) Non Small Cell Lung Cancer (NSCLC) - INFORM

Study identifier:D7913L00071

ClinicalTrials.gov identifier:N/A

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

Official Title

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

Medical condition

Non-small cell lung cancer (NSCLC)

Phase

Phase 4

Healthy volunteers

No

Study drug

Gefitinib, Placebo

Sex

All

Actual Enrollment

296

Study type

Interventional

Age

18 Years +

Date

Study Start Date: 01 Sept 2008
Primary Completion Date: 01 Jan 2011
Study Completion Date: 01 Feb 2011

Study design

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Treatment

Verification:

Verified 01 Aug 2012 by AstraZeneca Pharmaceuticals

Sponsors

AstraZeneca Pharmaceuticals

Collaborators

-

Inclusion and exclusion criteria