Conditions: Caucasian Patients With EGFR Mutation Positive Advanced NSCLC
Keywords: Gefitinib EGFR TKI efficacy Caucasian patients EGFR mutation positive advanced NSCLC safety
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 1060
Healthy volunteers: no

Brief summary:
This study is carried out to see how Caucasian patients with lung cancer which has EGFR mutation will respond to gefitinib (IRESSA™) as a first line treatment. Safety data will also be collected and analysed to confirm that treatment with gefitinib is safe and well tolerated.

Detailed description:
An Open Label, Multicentre, Single Arm Study to Characterise the Efficacy, Safety and Tolerability of Gefitinib 250 mg (IRESSA™) as First line Treatment in Caucasian Patients, who have Epidermal Growth Factor Receptor (EGFR) Mutation Positive Locally Advanced or Metastatic Non-Small Cell Lung Cancer

Arms:
arm 1: gefitinib 250mg tablet

Interventions: intervention 1: Gefitinib
Intervention descriptions: intervention 1: 250mg tablet oral, once daily until objective disease progression is documented or until other discontinuation criterion is met

Protocol document: