Non Small Cell Lung Cancer (NSCLC)
Conditions
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.
Interventions
DRUGGefitinib and Nimotuzumab
Combination therapy group: Gefitinib(250mg daily) + Nimotuzumab (200mg weekly)
DRUGGefitinib
Mono-therapy group: Gefitinib(250mg daily)
Sponsors
Yonsei University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 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. |
| 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. |
| 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. |
Countries
South Korea
Outcome results
None listed