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

Primary Purpose

Non-Small Cell Lung Cancer

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Erlotinib HCl
MetMAb
placebo (0.9 % saline)
Sponsored by
Genentech, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-Small Cell Lung Cancer focused on measuring Tarceva, Lung Cancer, NSCLC

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    MetMAb + Erlotinib

    Placebo + Erlotinib

    Arm Description

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

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

    Outcomes

    Primary Outcome Measures

    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).
    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).

    Secondary Outcome Measures

    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.
    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.
    Duration of Overall Response

    Full Information

    First Posted
    February 27, 2009
    Last Updated
    March 2, 2017
    Sponsor
    Genentech, Inc.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00854308
    Brief Title
    A Study of MetMAb Administered to Patients With Advanced Non-Small Cell Lung Cancer, in Combination With Tarceva (Erlotinib)
    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)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2012
    Overall Recruitment Status
    Completed
    Study Start Date
    April 2009 (undefined)
    Primary Completion Date
    November 2010 (Actual)
    Study Completion Date
    January 2012 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Genentech, Inc.

    4. Oversight

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Non-Small Cell Lung Cancer
    Keywords
    Tarceva, Lung Cancer, NSCLC

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    137 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    MetMAb + Erlotinib
    Arm Type
    Experimental
    Arm Description
    MetMab 15 mg/kg intravenous (IV) infusion every 3 weeks + Erlotinib 150 mg orally once daily until progression of disease or unacceptable toxicity.
    Arm Title
    Placebo + Erlotinib
    Arm Type
    Placebo Comparator
    Arm Description
    Placebo IV infusion every 3 weeks + Erlotinib 150 mg orally daily until progression of disease or unacceptable toxicity.
    Intervention Type
    Drug
    Intervention Name(s)
    Erlotinib HCl
    Other Intervention Name(s)
    Tarceva
    Intervention Description
    Erlotinib 150 mg oral dose once daily.
    Intervention Type
    Drug
    Intervention Name(s)
    MetMAb
    Intervention Description
    MetMab (a monovalent antagonist antibody to the receptor MET) 15 mg/kg in 250 CC 0.9% saline intravenous infusion every 3 weeks.
    Intervention Type
    Drug
    Intervention Name(s)
    placebo (0.9 % saline)
    Intervention Description
    Placebo Intravenous infusion every 3 weeks.
    Primary Outcome Measure Information:
    Title
    Progression-free Survival
    Description
    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 Frame
    Time from randomization to the first occurrence of progression/relapse or death on study. (Up to 20 months)
    Title
    Progression-free Survival in Patients With Met Diagnostic-Positive Tumors
    Description
    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 Frame
    Time from randomization to the first occurrence of progression/relapse or death on study. (Up to 20 months)
    Secondary Outcome Measure Information:
    Title
    Percentage of Participants With Objective Response
    Description
    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.
    Time Frame
    Start of treatment until disease progression/recurrence or death on study. (Up to 20 months)
    Title
    Percentage of Participants With Objective Response in Patients With Met Diagnostic-Positive Tumors
    Description
    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.
    Time Frame
    Start of treatment until disease progression/recurrence or death on study. (Up to 20 months)
    Title
    Duration of Overall Response
    Time Frame
    Date of initial response until date of progression or death on study. (Up to 20 months)

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Premal Patel, M.D., Ph.D.
    Organizational Affiliation
    Genentech, Inc.
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Learn more about this trial

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

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