First-line Treatment for Adenocarcinoma Patients With Epidermal Growth Factor Receptor (EGFR) Mutation

An Open-label, Multi-centre Study to Evaluate Efficacy and Safety of Gefitinib as the First-line Treatment for Locally Advanced (IIIB), Metastatic (IV) or Recurrent Pulmonary Adenocarcinoma Patients With Epidermal Growth Factor Receptor (EGFR) Mutation.

The purpose of this study is to evaluate the overall objective tumor response rate (ORR) of Gefitinib.

Inclusion Criteria:

• Patients require histological biopsy and paraffin block more than 5mg from the original tumour or metastatic site to perform EGFR mutational analysis
• WHO Performance Status 0-2
• No prior chemotherapy, biological or immunological therapy/surgery

Exclusion Criteria:

• Any evidence of clinically active interstitial lung disease
• Newly diagnosed CNS metastases that have not yet been definitively treated with surgery /radiation
• Patients with previously diagnosed and treated CNS metastases or spinal cord compression