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A Study of Onartuzumab (MetMAb) in Combination With Tarceva (Erlotinib) in Participants With Met Diagnostic-Positive Non-Small Cell Lung Cancer Who Have Received Chemotherapy For Advanced or Metastatic Disease (MetLung)

This study has been completed.
Sponsor:
Collaborator:
Hoffmann-La Roche
Information provided by (Responsible Party):
Genentech, Inc.
ClinicalTrials.gov Identifier:
NCT01456325
First received: October 18, 2011
Last updated: September 22, 2016
Last verified: September 2016
  Purpose
This randomized, multicenter, double-blind, placebo-controlled study will evaluate the efficacy and safety of onartuzumab (MetMAb) in combination with Tarceva (erlotinib) in participants with incurable non-small cell lung cancer identified to be Met diagnostic-positive. Participants will be randomized to receive either onartuzumab (MetMAb) or placebo in combination with erlotinib. Anticipated time on study treatment is until disease progression or unacceptable toxicity occurs.

Condition Intervention Phase
Non-Squamous Non-Small Cell Lung Cancer
Drug: Erlotinib
Drug: Onartuzumab (MetMab)
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
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, Inc.:

Primary Outcome Measures:
  • Overall Survival [ Time Frame: Randomization until death (up to approximately 18 months) (assessed at the treating physician's discretion using the local standard-of-care practice) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer Module (EORTC QLQ-LC13) Scores [ Time Frame: Screening, Day 1 of Cycles 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22 (cycle length = 21 days), study drug discontinuation visit (up to approximately 18 months) ] [ Designated as safety issue: No ]
  • Onartuzumab Serum Concentrations [ Time Frame: 1 hour pre-onartuzumab (Pr-O) infusion on Day 1 of Cycles 1, 2, and 4, 1 hour post-onartuzumab (Po-O) infusion on Day 1 of Cycle 1 (cycle length = 21 days and duration of infusion = 60 minutes), End of treatment (up to approximately 18 months) ] [ Designated as safety issue: No ]
  • Percentage of Participants With Disease Progression or Death [ Time Frame: Randomization until disease progression or death, whichever occurred first (up to approximately 18 months) (assessed at the treating physician's discretion using the local standard-of-care practice) ] [ Designated as safety issue: No ]
  • Progression Free Survival (PFS) [ Time Frame: Randomization until disease progression or death, whichever occurred first (up to approximately 18 months) (assessed at the treating physician's discretion using the local standard-of-care practice) ] [ Designated as safety issue: No ]
  • Percentage of Participants with an Objective Response Assessed Using RECIST V 1.1 [ Time Frame: Randomization until disease progression or death, whichever occurred first (up to approximately 18 months) (assessed at the treating physician's discretion using the local standard-of-care practice) ] [ Designated as safety issue: No ]

Enrollment: 499
Study Start Date: January 2012
Study Completion Date: January 2016
Primary Completion Date: January 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Onartuzumab+Erlotinib
Participants will receive onartuzumab 15 milligrams per kilogram (mg/kg) intravenous (IV) infusion on Day 1 of every cycle of 3 weeks along with erlotinib 150 mg tablet orally once daily (QD) from Day 1, Cycle 1 until there is evidence of disease progression, death, or unacceptable toxicity, whichever occurred first.
Drug: Erlotinib
Participants will receive erlotinib 150 mg tablet orally once daily from Day 1, Cycle 1.
Other Name: Tarceva
Drug: Onartuzumab (MetMab)
Participants will receive onartuzumab 15 mg/kg IV infusion on Day 1 of every 3-week cycle.
Other Name: RO5490258
Placebo Comparator: Placebo+Erlotinib
Participants will receive onartuzumab matching placebo on Day 1 of every cycle of 3 weeks along with erlotinib 150 mg tablet orally QD from Day 1, Cycle 1 until there is evidence of disease progression, death, or unacceptable toxicity, whichever occurred first.
Drug: Erlotinib
Participants will receive erlotinib 150 mg tablet orally once daily from Day 1, Cycle 1.
Other Name: Tarceva
Drug: Placebo
Participants will receive onartuzumab matching placebo on Day 1 of every 3-week cycle.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adult participants, greater than or equal to (>/=) 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 immunohistochemistry (IHC)
  • Results of endothelial growth factor receptor (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; participants 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 participant 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 human immunodefinciency (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, Inc.
Hoffmann-La Roche
Investigators
Study Director: Ivor Caro, M.D. Genentech, Inc.
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Genentech, Inc.
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 22, 2016
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 Hydrochloride
Antibodies, Monoclonal
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 26, 2016