A Study of MetMAb Administered to Patients With Advanced Non-Small Cell Lung Cancer, in Combination With Tarceva (Erlotinib)

Genentech

Status and phase: Completed; Phase 2

Conditions: Non-Small Cell Lung Cancer

Treatments: Drug: MetMAb; Drug: Erlotinib HCl; Drug: placebo (0.9 % saline)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00854308

OAM4558g

Details and patient eligibility

About

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- and third-line Non-Small Cell Lung Cancer (NSCLC). Up to 180 patients will be randomized in a 1:1 ratio to one of the two treatment arms.

Enrollment: 137 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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 criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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137 participants in 2 patient groups, including a placebo group

MetMAb + Erlotinib

Experimental group

Description:

MetMab 15 mg/kg intravenous (IV) infusion every 3 weeks + Erlotinib 150 mg orally once daily until progression of disease or unacceptable toxicity.

Treatment:

Drug: MetMAb

Drug: Erlotinib HCl

Placebo + Erlotinib

Placebo Comparator group

Description:

Placebo IV infusion every 3 weeks + Erlotinib 150 mg orally daily until progression of disease or unacceptable toxicity.

Treatment:

Drug: Erlotinib HCl

Drug: placebo (0.9 % saline)