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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Genentech
ClinicalTrials.gov Identifier:
NCT00854308
First received: February 27, 2009
Last updated: November 14, 2012
Last verified: November 2012
  Purpose

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.


Condition Intervention Phase
Non-Small Cell Lung Cancer
Drug: Erlotinib HCl
Drug: MetMAb
Drug: placebo (0.9 % saline)
Phase 2

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

Resource links provided by NLM:


Further study details as provided by Genentech:

Primary Outcome Measures:
  • Progression-free Survival [ Time Frame: Time from randomization to the first occurrence of progression/relapse or death on study. (Up to 20 months) ] [ Designated as safety issue: No ]
    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 Frame: Time from randomization to the first occurrence of progression/relapse or death on study. (Up to 20 months) ] [ Designated as safety issue: No ]

    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:
  • Percentage of Participants With Objective Response [ Time Frame: Start of treatment until disease progression/recurrence or death on study. (Up to 20 months) ] [ Designated as safety issue: No ]

    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 [ Time Frame: Start of treatment until disease progression/recurrence or death on study. (Up to 20 months) ] [ Designated as safety issue: No ]

    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 [ Time Frame: Date of initial response until date of progression or death on study. (Up to 20 months) ] [ Designated as safety issue: No ]

Enrollment: 137
Study Start Date: April 2009
Study Completion Date: January 2012
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: MetMAb + Erlotinib
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
Erlotinib 150 mg oral dose once daily.
Other Name: Tarceva
Drug: 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 Comparator: Placebo + Erlotinib
Placebo IV infusion every 3 weeks + Erlotinib 150 mg orally daily until progression of disease or unacceptable toxicity.
Drug: Erlotinib HCl
Erlotinib 150 mg oral dose once daily.
Other Name: Tarceva
Drug: placebo (0.9 % saline)
Placebo Intravenous infusion every 3 weeks.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00854308

Sponsors and Collaborators
Genentech
Investigators
Study Director: Premal Patel, M.D., Ph.D. Genentech
  More Information

No publications provided

Responsible Party: Genentech
ClinicalTrials.gov Identifier: NCT00854308     History of Changes
Other Study ID Numbers: OAM4558g
Study First Received: February 27, 2009
Results First Received: September 9, 2011
Last Updated: November 14, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Genentech:
Tarceva
Lung Cancer
NSCLC

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Erlotinib
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 30, 2014