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NCT Number: NCT01456325

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 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.

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Key information

Conditions

Non-Squamous Non-Small Cell Lung Cancer

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

La Plata, Argentina

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Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Erlotinib

Drug

Participants will receive erlotinib 150 mg tablet orally once daily from Day 1, Cycle 1.

Other names: Tarceva

Onartuzumab (MetMab)

Drug

Participants will receive onartuzumab 15 mg/kg IV infusion on Day 1 of every 3-week cycle.

Other names: RO5490258

Placebo

Drug

Participants will receive onartuzumab matching placebo on Day 1 of every 3-week cycle.

Primary outcomes

  1. 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)

Secondary outcomes

  1. 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)

  2. 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)

  3. 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)

  4. 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)

  5. 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)

Sponsors and collaborators

Lead sponsor

Genentech, Inc.

Industry

Collaborators

  • Hoffmann-La Roche

Registry information

Official study 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

Important dates

Study start
2012
Primary completion
2016
Study completion
2016
First posted
Oct 20, 2011
Registry last updated
Nov 2, 2016

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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