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)
20 Years
N/A
Both
Non Small Cell Lung Cancer (NSCLC)
Trial Information
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.
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Progression free survival rate at 3 months
Outcome Description:
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.
Outcome Time Frame:
3 months after randomization of last patient
Safety Issue:
No
Authority:
South Korea: Korea Food and Drug Administration (KFDA)
Study ID:
4-2011-0662
NCT ID:
NCT01498562
Start Date:
December 2011
Completion Date:
January 2014
Related Keywords:
- Non Small Cell Lung Cancer (NSCLC)
- Carcinoma, Non-Small-Cell Lung
- Lung Neoplasms
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