Clinical trial NCT00854308: A Study of MetMAb Administered to Patients With Advanced Non-Small Cell Lung Cancer, in Combination With Tarceva (Erlotinib)
Official title: A Randomized, Phase II, Multicenter, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Activity of MetMAb, a Monovalent Antagonist Antibody to the Receptor Met, Administered to Patients With Advanced Non-Small Cell Lung Cancer, in Combination With Tarceva (Erlotinib)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Non-Small Cell Lung Cancer
Keywords: Tarceva
Lung Cancer
NSCLC
Lead sponsor: Genentech, Inc.
Sponsor class: INDUSTRY
First posted: 2009-03-03
Enrollment: 137
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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- 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

Primary outcomes:
measure: Progression-free Survival
timeFrame: Time from randomization to the first occurrence of progression/relapse or death on study. (Up to 20 months)
measure: Progression-free Survival in Patients With Met Diagnostic-Positive Tumors
timeFrame: Time from randomization to the first occurrence of progression/relapse or death on study. (Up to 20 months)
Secondary outcomes:
measure: Percentage of Participants With Objective Response
timeFrame: Start of treatment until disease progression/recurrence or death on study. (Up to 20 months)
measure: Percentage of Participants With Objective Response in Patients With Met Diagnostic-Positive Tumors
timeFrame: Start of treatment until disease progression/recurrence or death on study. (Up to 20 months)
measure: Duration of Overall Response
timeFrame: Date of initial response until date of progression or death on study. (Up to 20 months)
Other outcomes:
Locations:
Study officials:
affiliation: Genentech, Inc.
name: Premal Patel, M.D., Ph.D.
role: STUDY_DIRECTOR
References: