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

Phase 2

Completed

• Conditions: Non Small Cell Lung Cancer (NSCLC)
• Interventions: Drug: Gefitinib; Drug: Gefitinib and Nimotuzumab

• Registration Number: NCT01498562
• Lead Sponsor: Yonsei University

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 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 Timeline

• Study Start: 2011-12
• Study First Submitted: 2011-12-20
• Study First Submitted QC: 2011-12-22
• Study First Posted: 2011-12-23
• Primary Completion: 2014-06
• Study Completion: 2014-06
• Status Verified: 2014-11
• Last Update Submitted: 2014-11-26
• Last Update Posted: 2014-12-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 160

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Gefitinib alone	Gefitinib	Mono-therapy group: Gefitinib(250mg daily)
Gefitinib plus Nimotuzumab	Gefitinib and Nimotuzumab	Combination therapy group: Gefitinib(250mg daily) and Nimotuzumab (200mg weekly)

Primary Outcome Measures

Name	Time	Method
Progression free survival rate at 3 months	3 months after randomization of last patient	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.

Secondary Outcome Measures

Name	Time	Method
Progression free survival (PFS)	3 months after randomization of last patient	Progression free survival (PFS) defined as the time from randomized date to the progression date or the preceded date of death date due to any cause.
Overall safety profile	3 months after randomization of last patient	Overall safety profile verified as relevance of adverse events and laboratory abnormality in the study and grades granted based on (USA National Cancer Center) Common Terminology Criteria for Adverse Events such as the type, frequency and severity (CTCAE), v4.0.
Overall survival (OS)	3 months after randomization of last patient	Overall survival (OS) defined as the period from randomly assigned point of time to the date of death due to any cause.
Objective response rate (ORR)	3 months after randomization of last patient	Overall objective response rate (ORR) is the best response rate stipulated as complete response (CR) or partial response (PR) (target lesion and tumor response defined according to RECIST guideline version 1.1) and identified as percentage of the confirmed patients.

Trial Locations

Locations (1)

Severance hospital, Yonsei Cancer Center; 🇰🇷 Seoul, Korea, Republic of