A Study of Onartuzumab (MetMAb) in Combination With Tarceva (Erlotinib) in Patients With Met Diagnostic-Positive Non-Small Cell Lung Cancer Who Have Received Chemotherapy For Advanced or Metastatic Disease (MetLung)



Status:Completed
Conditions:Lung Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:6/3/2016
Start Date:July 2011
End Date:January 2016

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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

This randomized, multicenter, double-blind, placebo-controlled study will evaluate the
efficacy and safety of onartuzumab (MetMAb) in combination with Tarceva (erlotinib) in
patients with incurable non-small cell lung cancer identified to be Met diagnostic-positive.
Patients will be randomized to receive either onartuzumab (MetMAb) or placebo in combination
with Tarceva. Anticipated time on study treatment is until disease progression or
unacceptable toxicity occurs.


Inclusion Criteria:

- Adult patients, >/= 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 IHC

- Results of 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; patients 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 patient 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 HIV infection
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