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


Tracking Information

Start Date  ICMJEApril 2009
Estimated Primary Completion DateSeptember 2012   (final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE 
 (submitted: April 24, 2009)		Progression-free survival [ Time Frame: Time from randomization to the first occurrence of progression or relapse ] [ Designated as safety issue: No ]
Original Primary Outcome Measures  ICMJE 
 (submitted: February 27, 2009)		Progression-free survival [ Time Frame: Length of study ] [ Designated as safety issue: No ]
Change HistoryComplete list of historical versions of study NCT00854308 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE 
 (submitted: April 24, 2009)
  • Overall response [ Time Frame: Start of treatment until disease progression/recurrence ] [ Designated as safety issue: No ]
  • Duration of overall response [ Time Frame: Date of initial response until date of progression or death ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures  ICMJE 
 (submitted: February 27, 2009)
  • Overall response [ Time Frame: Length of study ] [ Designated as safety issue: No ]
  • Duration of overall response [ Time Frame: Length of study ] [ Designated as safety issue: No ]

Descriptive Information

Brief Title  ICMJEA Study of MetMAb Administered to Patients With Advanced Non-Small Cell Lung Cancer, in Combination With Tarceva (Erlotinib)
Official Title  ICMJEA 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)
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 120 patients will be randomized in a 1:1 ratio to one of the two treatment arms.

Detailed Description 
Study PhasePhase II
Study Type  ICMJEInterventional
Study Design  ICMJETreatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment
Condition  ICMJENon-small Cell Lung Cancer
Intervention  ICMJE
  • Drug: erlotinib HCl
    Oral repeating dose
  • Drug: MetMAb
    Intravenous repeating dose
  • Drug: placebo
    Intravenous repeating dose
Study Arms / Comparison Groups
  • 1: Experimental
    Interventions:
    • Drug: erlotinib HCl
    • Drug: MetMAb
  • 2: Placebo Comparator
    Interventions:
    • Drug: erlotinib HCl
    • Drug: placebo

Recruitment Information

Estimated Enrollment  ICMJE120
Completion Date 
Estimated Primary Completion DateSeptember 2012   (final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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 RECIST
  • At least one measurable lesion on a pre-treatment FDG-PET scan that is also a target lesion on 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 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) 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
GenderBoth
Ages18 Years and older
Accepts Healthy VolunteersNo
Contacts  ICMJE
Contact: Susan Owenowen.susan@gene.com
Location Countries  ICMJEUnited States,   Australia,   Canada,   France,   Poland,   Russian Federation

Administrative Information

NCT ID  ICMJENCT00854308
Responsible PartyClinical Trials Posting Group, Genentech, Inc.
Study ID Numbers  ICMJEOAM4558g
Study Sponsor  ICMJEGenentech
Collaborators  ICMJE 
Investigators  ICMJE
Study Director:Amy Peterson, M.D.Genentech
Information Provided ByGenentech