Trial record 1 of 1 for:    NCT01456325
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A Study of Onartuzumab (MetMAb) in Combination With Tarceva (Erlotinib) in Patients With Met Diagnostic-Positive Non-Small Cell Lung Cancer Who Have Received Chemotherapy For Advanced or Metastatic Disease (MetLung)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Hoffmann-La Roche
Information provided by (Responsible Party):
Genentech
ClinicalTrials.gov Identifier:
NCT01456325
First received: October 18, 2011
Last updated: September 2, 2014
Last verified: September 2014
  Purpose

This randomized, multicenter, double-blind, placebo-controlled study will evalua te the efficacy and safety of onartuzumab (MetMAb) in combination with Tarceva ( erlotinib) in patients with incurable non-small cell lung cancer identified to b e Met diagnostic-positive. Patients will be randomized to receive either onartuz umab (MetMAb) or placebo in combination with Tarceva. Anticipated time on study treatment is until disease progression or unacceptable toxicity occurs.


Condition Intervention Phase
Non-Small Cell Lung Cancer
Drug: onartuzumab [MetMAb]
Drug: erlotinib [Tarceva]
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Phase III, Multicenter, Double-Blind, Placebo-Controlled Study Evaluating Efficacy and Safety of Onartuzumab (Metmab) in Combination With Tarceva (Erlotinib) in Patients With Met Diagnostic-Positive Non-Small Cell Lung Cancer Who Have Received Standard Chemotherapy for Advanced/Metastatic Disease

Resource links provided by NLM:


Further study details as provided by Genentech:

Primary Outcome Measures:
  • Overall survival [ Time Frame: time from randomization to death due to any cause, up to approximately 40 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Progression-free survival, tumor assessments according to RECIST criteria [ Time Frame: time between date of randomization and the date of first documented disease progression or death, whichever occurs first, up to approximately 40 months ] [ Designated as safety issue: No ]
  • Overall response rate (complete response + partial response) [ Time Frame: up to approximately 40 months ] [ Designated as safety issue: No ]
  • Safety: Incidence of adverse events [ Time Frame: up to approximately 40 months ] [ Designated as safety issue: No ]

Enrollment: 499
Study Start Date: July 2011
Estimated Study Completion Date: September 2015
Estimated Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A Drug: onartuzumab [MetMAb]
Repeating intravenous dose
Drug: erlotinib [Tarceva]
Repeating oral dose
Active Comparator: B Drug: erlotinib [Tarceva]
Repeating oral dose
Drug: Placebo
Repeating intravenous dose

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adult patients, >/= 18 years of age
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-1
  • Histologically or cytologically confirmed incurable Stage IIIb/IV NSCLC tumor
  • Met diagnostic-positive status tested by IHC
  • Results of EGFR-activating mutation testing
  • Radiographic evidence of disease
  • Prior treatment with at least one platinum-based line of treatment (for stage IIIb/IV) and no more than one additional line of chemotherapy treatment; the last dose of chemotherapy must have been administered >/= 21 days prior to Day 1
  • availability of tissue sample for diagnostic testing is required

Exclusion Criteria:

  • 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 (EGFR inhibitors including but not limited to gefitinib, erlotinib and cetuximab)
  • Brain metastases or spinal cord compression not definitively treated with surgery and/or radiation, or previously treated central nervous system (CNS) metastases or spinal cord compression without evidence of stable disease for >/= 14 days
  • History of another malignancy in the previous 3 years, unless cured by surgery alone and continuously disease free for at least 3 years; patients with prior history of non-invasive cancers are eligible
  • Inadequate hematological, biochemical or organ function
  • Significant history of cardiac disease
  • Serious active infection at time of randomization or other serious underlying medical conditions that would impair the ability of the patient to receive protocol treatment
  • Any inflammatory changes of the surface of the eye
  • Clinically significant gastro-intestinal disease, including uncontrolled inflammatory gastro-intestinal diseases
  • Pregnant or lactating women
  • Positive for HIV infection
  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: NCT01456325

  Show 213 Study Locations
Sponsors and Collaborators
Genentech
Hoffmann-La Roche
Investigators
Study Director: Holger Thurm, M.D. Genentech
  More Information

No publications provided

Responsible Party: Genentech
ClinicalTrials.gov Identifier: NCT01456325     History of Changes
Other Study ID Numbers: OAM4971g, GO27761, 2011-002224-40
Study First Received: October 18, 2011
Last Updated: September 2, 2014
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on September 18, 2014