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

Yonsei University

Status and phase: Completed; Phase 2

Conditions: Non Small Cell Lung Cancer (NSCLC)

Treatments: Drug: Gefitinib; Drug: Gefitinib and Nimotuzumab

Study type: Interventional

Funder types: Other

Identifiers

NCT01498562

4-2011-0662

Details and patient eligibility

About

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

Full 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 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.

Enrollment: 160 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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160 participants in 2 patient groups

Gefitinib plus Nimotuzumab

Experimental group

Description:

Combination therapy group: Gefitinib(250mg daily) and Nimotuzumab (200mg weekly)

Treatment:

Drug: Gefitinib and Nimotuzumab

Gefitinib alone

Active Comparator group

Description:

Mono-therapy group: Gefitinib(250mg daily)

Treatment:

Drug: Gefitinib