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)

• Status: Completed
• Trial end date: 2016-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Genentech, Inc.
• Collaborator: Hoffmann-La Roche
• Treatments: Antibodies, Monoclonal; Erlotinib Hydrochloride

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