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)

Completed · Phase 3 · Has a placebo group

Conditions studied: Non-Squamous Non-Small Cell Lung Cancer

In brief

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.

Key facts

Study ID

NCT01456325

Run by

Genentech, Inc.

People needed

494

Starts

2012-01-01

Expected to finish

2016-01-01

Last updated by the study team

2016-11-02

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Study site — Hayward, California, United States
• Study site — Modesto, California, United States
• Study site — Oakland, California, United States
• Study site — Orange, California, United States
• Study site — Roseville, California, United States
• Study site — Sacramento, California, United States
• Study site — Sacramento, California, United States
• Study site — San Diego, California, United States
• Study site — San Francisco, California, United States
• Study site — San Jose, California, United States
• Study site — Santa Clara, California, United States
• Study site — South San Francisco, California, United States
• Study site — Vallejo, California, United States
• Study site — Walnut Creek, California, United States
• Study site — Boca Raton, Florida, United States
• Study site — Clearwater, Florida, United States
• Study site — Fort Myers, Florida, United States
• Study site — Jacksonville, Florida, United States
• Study site — Jacksonville, Florida, United States
• Study site — Chicago, Illinois, United States
• Study site — Urbana, Illinois, United States
• Study site — Bettendorf, Iowa, United States
• Study site — Sioux City, Iowa, United States
• Study site — Louisville, Kentucky, United States
• Study site — Chandler, Arizona, United States

Full record on ClinicalTrials.gov

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