Phase 2 N=137 Randomized Double-blind Treatment

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

Non-Small Cell Lung Cancer

Bottom Line

View on ClinicalTrials.gov: NCT00854308 ↗

Enrolled (actual)

137

Serious AEs

37.5%

Results posted

Oct 2011

Primary outcome: Primary: Progression-free Survival — 2.2; 2.6 months — p=0.6873

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Erlotinib HCl (Drug); MetMAb (Drug); placebo (0.9 % saline) (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Genentech, Inc.
Primary completion: Nov 2010

Outcome Measures

Outcome	Result	p-value
PRIMARY Progression-free Survival	2.2; 2.6	0.6873
PRIMARY Progression-free Survival in Patients With Met Diagnostic-Positive Tumors	2.9; 1.5	0.0418 sig
SECONDARY Percentage of Participants With Objective Response	5.8; 4.4	0.7101
SECONDARY Percentage of Participants With Objective Response in Patients With Met Diagnostic-Positive Tumors	8.6; 3.2	0.3671
SECONDARY Duration of Overall Response	—	—

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00854308). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.