Status:
COMPLETED
A Study of MetMAb Administered to Patients With Advanced Non-Small Cell Lung Cancer, in Combination With Tarceva (Erlotinib)
Lead Sponsor:
Genentech, Inc.
Conditions:
Non-Small Cell Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This is a Phase II, double-blind, randomized, multicenter trial designed to preliminarily evaluate the activity and safety of treatment with MetMAb + erlotinib versus erlotinib + placebo in second- an...
Eligibility Criteria
Inclusion
- Patients must meet the following criteria for study entry:
- Histologically confirmed NSCLC
- Availability of a tumor specimen
- Recurrent or progressive disease following at least one chemo containing regimen for Stage IIIB/IV disease
- Measurable disease in accordance with Response Evaluation Criteria in Solid Tumors (RECIST)
- At least one measurable lesion on a pre-treatment 18-fluorodeoxyglcose-positron emission tomography (FDG-PET) scan that is also a target lesion on computed tomography (CT) according to RECIST
Exclusion
- More than two prior treatments for Stage IIIB/IV
- More than 30 days of exposure to an investigational or marketed agent that can act by EGFR inhibition, or a known epidermal growth factor receptor (EGFR)-related toxicity resulting in dose modifications
- Chemotherapy, biologic therapy, radiotherapy or investigational drug within 28 days prior to randomization
- Untreated and/or active (progressing or requiring anticonvulsants or corticosteroids for symptomatic control) central nervous system (CNS) metastasis
- History of serious systemic disease within the past 6 months prior to randomization
- Uncontrolled diabetes
- Major surgical procedure or significant traumatic injury within 28 days prior to randomization
- Anticipation of need for a major surgical procedure during the course of the study
- Local palliative radiotherapy within 7 days prior to randomization or persistent adverse effects from radiotherapy that have not been resolved to Grade II or less prior to randomization
- Symptomatic hypercalcemia requiring continued use of bisphosphonate therapy
Key Trial Info
Start Date :
April 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2012
Estimated Enrollment :
137 Patients enrolled
Trial Details
Trial ID
NCT00854308
Start Date
April 1 2009
End Date
January 1 2012
Last Update
March 31 2017
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