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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)

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ClinicalTrials.gov Identifier: NCT01456325
Recruitment Status : Completed
First Posted : October 20, 2011
Last Update Posted : November 2, 2016
Sponsor:
Collaborator:
Hoffmann-La Roche
Information provided by (Responsible Party):
Genentech, Inc.

Tracking Information
First Submitted Date  ICMJE October 18, 2011
First Posted Date  ICMJE October 20, 2011
Last Update Posted Date November 2, 2016
Study Start Date  ICMJE January 2012
Actual Primary Completion Date January 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 22, 2016)
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) ]
Original Primary Outcome Measures  ICMJE
 (submitted: October 19, 2011)
Overall survival [ Time Frame: time from randomization to death due to any cause, up to approximately 39 months ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 22, 2016)
  • 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) ]
  • 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) ]
  • 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) ]
  • 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) ]
  • 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) ]
Original Secondary Outcome Measures  ICMJE
 (submitted: October 19, 2011)
  • 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 39 months ]
  • Overall response rate (complete response + partial response) [ Time Frame: up to approximately 39 months ]
  • Safety: Incidence of adverse events [ Time Frame: up to approximately 39 months ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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)
Official Title  ICMJE 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
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Non-Squamous Non-Small Cell Lung Cancer
Intervention  ICMJE
  • 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
  • Drug: Placebo
    Participants will receive onartuzumab matching placebo on Day 1 of every 3-week cycle.
Study Arms  ICMJE
  • 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.
    Interventions:
    • Drug: Erlotinib
    • Drug: Onartuzumab (MetMab)
  • 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.
    Interventions:
    • Drug: Erlotinib
    • Drug: Placebo
Publications * Koeppen H, Yu W, Zha J, Pandita A, Penuel E, Rangell L, Raja R, Mohan S, Patel R, Desai R, Fu L, Do A, Parab V, Xia X, Januario T, Louie SG, Filvaroff E, Shames DS, Wistuba I, Lipkind M, Huang J, Lazarov M, Ramakrishnan V, Amler L, Phan SC, Patel P, Peterson A, Yauch RL. Biomarker analyses from a placebo-controlled phase II study evaluating erlotinib±onartuzumab in advanced non-small cell lung cancer: MET expression levels are predictive of patient benefit. Clin Cancer Res. 2014 Sep 1;20(17):4488-98. doi: 10.1158/1078-0432.CCR-13-1836. Epub 2014 Mar 31.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 1, 2016)
494
Original Estimated Enrollment  ICMJE
 (submitted: October 19, 2011)
480
Actual Study Completion Date  ICMJE January 2016
Actual Primary Completion Date January 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Argentina,   Australia,   Belgium,   Brazil,   Canada,   Chile,   Croatia,   France,   Germany,   Hong Kong,   Hungary,   Ireland,   Israel,   Italy,   Japan,   Korea, Republic of,   Netherlands,   Peru,   Poland,   Russian Federation,   Serbia,   South Africa,   Spain,   Taiwan,   Ukraine,   United Kingdom,   United States
Removed Location Countries India,   Romania
 
Administrative Information
NCT Number  ICMJE NCT01456325
Other Study ID Numbers  ICMJE OAM4971g
GO27761 ( Other Identifier: Hoffmann-La Roche )
2011-002224-40 ( EudraCT Number )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Genentech, Inc.
Study Sponsor  ICMJE Genentech, Inc.
Collaborators  ICMJE Hoffmann-La Roche
Investigators  ICMJE
Study Director: Ivor Caro, M.D. Genentech, Inc.
PRS Account Genentech, Inc.
Verification Date November 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP