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Completed

NCT Number: NCT00854308

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

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.

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Key information

Conditions

Non-small Cell Lung Cancer Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Erlotinib HCl

Drug

Erlotinib 150 mg oral dose once daily.

Other names: Tarceva

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.

placebo (0.9 % saline)

Drug

Placebo Intravenous infusion every 3 weeks.

Primary outcomes

  1. Progression-free Survival

    Time frame: 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).

  2. 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)

    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 outcomes

  1. Percentage of Participants With Objective Response

    Time frame: 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.

  2. 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)

    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.

  3. Duration of Overall Response

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

Sponsors and collaborators

Lead sponsor

Genentech, Inc.

Industry

Registry information

Official study 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)

Important dates

Study start
2009
Primary completion
2010
Study completion
2012
First posted
Mar 3, 2009
Registry last updated
Mar 31, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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