Combining nimotuzumab to gefitinib may not only potentiate cellular cytotoxicity, but may also assist in overcoming inherent or acquired resistance to gefitinib alone.

Reversible EGFR tyrosine kinase inhibitors (TKI), such as gefitinib, were shown to be effective in patients with non-small cell lung cancer (NSCLC). However, patients almost invariably develop resistance to TKIs and have disease progression. Nimotuzumab is a humanized monoclonal antibody targeting the EGFR.

Combining nimotuzumab to gefitinib may not only potentiate cellular cytotoxicity, but may also assist in overcoming inherent or acquired resistance to gefitinib alone.

Inclusion Criteria:

• Provision of written informed consent prior to any study specific procedures
• Unresectable non-small cell lung cancer
• ECOG performance status of 0 to 2
• Male or female; ≥ 20 years of age
• Subjects whose disease has progressed after platinum-based chemotherapy
• Subjects with measurable lesion

Exclusion Criteria:

• Inadequate organ functions
• Disease progression after 2 or more previous chemotherapy regimens
• Prior therapy with EGFR-tyrosine kinase inhibitor or Anti-EGFR Monoclonal Ab
• Any clinically significant gastrointestinal abnormalities
• Past medical history of interstitial lung disease
• Pregnant or lactating female