Status:
COMPLETED
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)
Lead Sponsor:
Genentech, Inc.
Collaborating Sponsors:
Hoffmann-La Roche
Conditions:
Non-Squamous Non-Small Cell Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 incurabl...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2016
Estimated Enrollment :
494 Patients enrolled
Trial Details
Trial ID
NCT01456325
Start Date
January 1 2012
End Date
January 1 2016
Last Update
November 2 2016
Active Locations (213)
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1
Chandler, Arizona, United States, 85224
2
Hayward, California, United States, 94545
3
Modesto, California, United States, 95355
4
Oakland, California, United States, 94611