Randomized Phase II Study of Gefitinib Plus Nimotuzumab Versus Gefitinib in Patients With Advanced Non-small Cell Lung Cancer: Dual-agent Molecular Targeting of EGFR (DATE)
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.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Progression free survival rate at 3 months
The progression-free survival rate at 3 months of the patients with no progression of disease or death due to any cause until 3 months is elapsed after being randomized.
3 months after randomization of last patient
South Korea: Korea Food and Drug Administration (KFDA)