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

Yonsei University160 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

160

Conditions

Non Small Cell Lung Cancer (NSCLC)

Interventions

Gefitinib and NimotuzumabDRUG

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

GefitinibDRUG

Mono-therapy group: Gefitinib(250mg daily)

Eligibility

Sex: ALLMin age: 20 Years

Medical Language ↔ Plain English

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

Locations (1)

Severance hospital, Yonsei Cancer Center

Seoul, South Korea

Outcomes

Primary Outcomes

Progression free survival rate at 3 months

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.