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

NCT00854308 | Completed Phase 2 Results

• 1 other identifier: OAM4558g
• Study Type: interventional
• Target: 137
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Non-Small Cell Lung Cancer

Keywords

Tarceva; Lung Cancer; NSCLC

Outcome Measures

Primary Outcomes (2)

• 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)

• 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)

Secondary Outcomes (3)

• Percentage of Participants With Objective Response

  Start of treatment until disease progression/recurrence or death on study. (Up to 20 months)

• 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)

• Duration of Overall Response

  Date of initial response until date of progression or death on study. (Up to 20 months)

Study Arms (2)

MetMAb + Erlotinib

EXPERIMENTAL

MetMab 15 mg/kg intravenous (IV) infusion every 3 weeks + Erlotinib 150 mg orally once daily until progression of disease or unacceptable toxicity.

Drug: Erlotinib HCl; Drug: MetMAb

Placebo + Erlotinib

PLACEBO COMPARATOR

Placebo IV infusion every 3 weeks + Erlotinib 150 mg orally daily until progression of disease or unacceptable toxicity.

Drug: Erlotinib HCl; Drug: placebo (0.9 % saline)

Interventions

Erlotinib HCl DRUG

Erlotinib 150 mg oral dose once daily.

Also known as: Tarceva

MetMAb + Erlotinib; Placebo + Erlotinib

MetMAb DRUG

MetMab (a monovalent antagonist antibody to the receptor MET) 15 mg/kg in 250 CC 0.9% saline intravenous infusion every 3 weeks.

MetMAb + Erlotinib

placebo (0.9 % saline) DRUG

Placebo Intravenous infusion every 3 weeks.

Placebo + Erlotinib

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Genentech, Inc.: lead

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Lung Neoplasms

Interventions

Erlotinib Hydrochloride; onartuzumab; Sodium Chloride

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Results Point of Contact

• Title: Medical Communications
• Organization: Hoffman-LaRoche

800-821-8590

Study Officials

• Premal Patel, M.D., Ph.D.

  Genentech, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 27, 2009
• First Posted: March 3, 2009
• Study Start: April 1, 2009
• Primary Completion: November 1, 2010
• Study Completion: January 1, 2012
• Last Updated: March 31, 2017
• Results First Posted: October 18, 2011

Record last verified: 2012-11