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)
Non-Squamous Non-Small Cell Lung Cancer
About this trial
This is an interventional treatment trial for Non-Squamous Non-Small Cell Lung Cancer
Eligibility 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
Onartuzumab+Erlotinib
Placebo+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.
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.