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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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)

Conditions
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Non Small Cell Lung Cancer (NSCLC)

Intervention / Treatment
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* Drug: Gefitinib and Nimotuzumab
* Drug: Gefitinib


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Gefitinib plus Nimotuzumab<br>Combination therapy group: Gefitinib(250mg daily) and Nimotuzumab (200mg weekly) | Drug: Gefitinib and Nimotuzumab<br>* Combination therapy group: Gefitinib(250mg daily) + Nimotuzumab (200mg weekly)<br>* Other names: h-R3;|
| Active Comparator: Gefitinib alone<br>Mono-therapy group: Gefitinib(250mg daily) | Drug: Gefitinib<br>* Mono-therapy group: Gefitinib(250mg daily)<br>* Other names: Iressa;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 3 months after randomization of last patient | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression free survival (PFS) | 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. | 3 months after randomization of last patient | 
| Overall survival (OS) | Overall survival (OS) defined as the period from randomly assigned point of time to the date of death due to any cause. | 3 months after randomization of last patient | 
| Overall safety profile | 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. | 3 months after randomization of last patient | 
| Objective response rate (ORR) | 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. | 3 months after randomization of last patient |