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

Non-Small Cell Lung Cancer Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00854308
• Other study ID #: OAM4558g
• Status: Completed
• Phase: Phase 2
• First received: February 27, 2009
• Last updated: November 14, 2012
• Start date: April 2009
• Est. completion date: January 2012

Study information

• Verified date: November 2012
• Source: Genentech, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 137
• Est. completion date: January 2012
• Est. primary completion date: November 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-Small Cell Lung Cancer

Intervention

Drug:
• Erlotinib HCl
Erlotinib 150 mg oral dose once daily.
• MetMAb
MetMab (a monovalent antagonist antibody to the receptor MET) 15 mg/kg in 250 CC 0.9% saline intravenous infusion every 3 weeks.
• placebo (0.9 % saline)
Placebo Intravenous infusion every 3 weeks.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Genentech, Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression-free Survival	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).	Time from randomization to the first occurrence of progression/relapse or death on study. (Up to 20 months)	No
Primary	Progression-free Survival in Patients With Met Diagnostic-Positive Tumors	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).	Time from randomization to the first occurrence of progression/relapse or death on study. (Up to 20 months)	No
Secondary	Percentage of Participants With Objective Response	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.	Start of treatment until disease progression/recurrence or death on study. (Up to 20 months)	No
Secondary	Percentage of Participants With Objective Response in Patients With Met Diagnostic-Positive Tumors	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.	Start of treatment until disease progression/recurrence or death on study. (Up to 20 months)	No
Secondary	Duration of Overall Response		Date of initial response until date of progression or death on study. (Up to 20 months)	No