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

Phase 2

Completed

• Conditions: Non-Small Cell Lung Cancer
• Interventions: Drug: Erlotinib HCl; Drug: MetMAb; Drug: placebo (0.9 % saline)

• Registration Number: NCT00854308
• Lead Sponsor: Genentech, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-02-27
• Study First Submitted QC: 2009-02-27
• Study First Posted: 2009-03-03
• Study Start: 2009-04
• Primary Completion: 2010-11
• Results First Submitted: 2011-09-09
• Results First Submitted QC: 2011-09-09
• Results First Posted: 2011-10-18
• Study Completion: 2012-01
• Status Verified: 2012-11
• Last Update Submitted: 2017-03-02
• Last Update Posted: 2017-03-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 137

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
MetMAb + Erlotinib	MetMAb	MetMab 15 mg/kg intravenous (IV) infusion every 3 weeks + Erlotinib 150 mg orally once daily until progression of disease or unacceptable toxicity.
Placebo + Erlotinib	Erlotinib HCl	Placebo IV infusion every 3 weeks + Erlotinib 150 mg orally daily until progression of disease or unacceptable toxicity.
Placebo + Erlotinib	placebo (0.9 % saline)	Placebo IV infusion every 3 weeks + Erlotinib 150 mg orally daily until progression of disease or unacceptable toxicity.
MetMAb + Erlotinib	Erlotinib HCl	MetMab 15 mg/kg intravenous (IV) infusion every 3 weeks + Erlotinib 150 mg orally once daily until progression of disease or unacceptable toxicity.

Primary Outcome Measures

Name	Time	Method
Progression-free Survival	Time from randomization to the first occurrence of progression/relapse or death on study. (Up to 20 months)	Progression-free survival was defined as the time from randomization to the first occurrence of progression or relapse (as per Response Evaluation Criteria in Solid Tumors (RECIST 1.0) and assessed by the site radiologist or investigator) or death on study from any cause (within 30 days of last treatment).
Progression-free Survival in Patients With Met Diagnostic-Positive Tumors	Time from randomization to the first occurrence of progression/relapse or death on study. (Up to 20 months)	Progression-free survival (PFS) in participants with Met Diagnostic-Positive tumors as determined by immunohistochemistry.; PFS was defined as the time from randomization to the first occurrence of progression or relapse (as per Response Evaluation Criteria in Solid Tumors (RECIST 1.0) and assessed by the site radiologist or investigator) or death on study from any cause (within 30 days of last treatment).

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants With Objective Response	Start of treatment until disease progression/recurrence or death on study. (Up to 20 months)	Objective response (partial and complete response as determined using RECIST 1.0).; Partial response was defined as at least a 30% decrease in the sum of the longest diameter of target lesions taking as reference the baseline sum longest diameter.; Complete response was defined as disappearance of all target lesions.
Percentage of Participants With Objective Response in Patients With Met Diagnostic-Positive Tumors	Start of treatment until disease progression/recurrence or death on study. (Up to 20 months)	Objective response (OR); partial and complete response as determined using RECIST 1.0 in patients with Met Diagnostic-Positive Tumors as determined by immunohistochemistry.; Partial response was defined as at least a 30% decrease in the sum of the longest diameter of target lesions taking as reference the baseline sum longest diameter.; Complete response was defined as disappearance of all target lesions.
Duration of Overall Response	Date of initial response until date of progression or death on study. (Up to 20 months)