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)

NCT01498562 Phase 2 COMPLETED

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

Details

Lead sponsor	Yonsei University
Phase	Phase 2
Status	COMPLETED
Enrolment	160
Start date	2011-12
Completion	2014-06

Conditions

• Non Small Cell Lung Cancer (NSCLC)

Interventions

• Gefitinib and Nimotuzumab
• Gefitinib

Primary outcomes

• Progression free survival rate at 3 months — 3 months after randomization of last patient
  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.

Countries

South Korea