Status:
COMPLETED
Phase II Study of Gefitinib Plus Nimotuzumab Versus Gefitinib in Non-small Cell Lung Cancer
Lead Sponsor:
Yonsei University
Conditions:
Non Small Cell Lung Cancer (NSCLC)
Eligibility:
All Genders
20+ years
Phase:
PHASE2
Brief Summary
Combining nimotuzumab to gefitinib may not only potentiate cellular cytotoxicity, but may also assist in overcoming inherent or acquired resistance to gefitinib alone.
Detailed Description
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 resista...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2014
Estimated Enrollment :
160 Patients enrolled
Trial Details
Trial ID
NCT01498562
Start Date
December 1 2011
End Date
June 1 2014
Last Update
December 2 2014
Active Locations (1)
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1
Severance hospital, Yonsei Cancer Center
Seoul, South Korea