A Study of MetMAb Administered to Patients With Advanced Non-Small Cell Lung Cancer, in Combination With Tarceva (Erlotinib)
Condition: Non-Small Cell Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Intervention: Erlotinib HCl; MetMAb; placebo (0.9 % saline)
Intervention description: Erlotinib 150 mg oral dose once daily.; MetMab (a monovalent antagonist antibody to the receptor MET) 15 mg/kg in 250 CC 0.9% saline intravenous infusion every 3 weeks.; Placebo Intravenous infusion every 3 weeks.
Intervention MeSH terms: Erlotinib Hydrochloride
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 137.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Tarceva; Lung Cancer; NSCLC

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- 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.
    

Eligibility criteria:

        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