Phase II Study of Gefitinib Plus Nimotuzumab Versus Gefitinib in Non-small Cell Lung Cancer

• Status: Completed
• Trial end date: 2014-06-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Yonsei University
• Treatments: Gefitinib; Nimotuzumab

Criteria

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