A Study of Onartuzumab in Combination With Erlotinib in Patients With MET-Positive Stage IIIB or IV Non-Small Cell Lung Cancer Carrying an Activating Epidermal Growth Factor Receptor (EGFR) Mutation



Status:Completed
Conditions:Lung Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:8/3/2016
Start Date:December 2013
End Date:February 2015

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A Randomized, Phase III, Multicenter, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of Onartuzumab in Combination With Erlotinib as First-Line Treatment for Patients With MET-Positive Unresectable Stage IIIb or IV Non-Small Cell Lung Cancer (NSCLC) Carrying an Activating EGFR Mutation

This multicenter, randomized, double-blind, placebo-controlled study will evaluate the
safety and efficacy of onartuzumab in combination with erlotinib in patients with previously
untreated, unresectable stage IIIB or IV non-small cell lung cancer identified to carry and
activating EGFR mutation and MET-positive. Patients will be randomized to receive either
onartuzumab 15 mg/kg intravenously every 3 weeks in combination with erlotinib 150 mg orally
daily or placebo in combination with erlotinib. Anticipated time on study treatment is until
disease progression or unacceptable toxicity occurs.


Inclusion Criteria:

- Adult patient, >/= 18 years of age

- Histologically confirmed, unresectable Stage IIIB or IV non-small cell lung cancer
(NSCLC)

- No prior treatment for unresectable Stage IIIB or IV NSCLC

- Measurable radiographic evidence of disease according to RECIST v1.1

- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

Exclusion Criteria:

- Prior exposure to agents targeting either the Hepatocyte Growth Factor (HGF) or MET
pathway

- Exposure to an investigational or marketed agent that can act by EGFR inhibition

- Pleural effusion, pericardial fluid, or ascites requiring drainage every other week
or more frequently

- Brain metastasis or spinal cord compression not definitively treated with surgery
and/or radiation, or previously diagnosed and treated central nervous system (CNS)
metastases or spinal cord compression without evidence of clinically stable disease
for >/=4 days. Note: Patients with treated CNS metastases who are asymptomatic and on
a stable dose of corticosteroids for >/= 14 days prior to randomization are eligible.

- History of another malignancy in the previous 5 years, unless cured by surgery alone
and continuously disease-free

- Radiographically evident interstitial lung disease , concurrent infection, or a
history of any of these conditions

- Inadequate hematologic, biochemical, and organ function

- Pregnant or lactating women

- Life expectancy of < 12 weeks

- Receipt of an investigational drug within 28 days prior to initiation of study
treatment
We found this trial at
16
sites
1205
mi
from
Fort Myers, FL
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1184
mi
from
Bakersfield, CA
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4608
mi
from
Caen,
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900
mi
from
Canton, OH
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610
mi
from
Chicago, IL
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1153
mi
from
Fullerton, CA
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1171
mi
from
Long Beach, CA
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1168
mi
from
Los Angeles, CA
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1168
mi
from
Los Angeles, CA
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699
mi
from
Marrero, LA
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690
mi
from
Metairie, LA
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618
mi
from
Nashville, TN
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1139
mi
from
Orlando, FL
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Saint Petersburg, Florida 33713
1117
mi
from
Saint Petersburg, FL
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San Luis Obispo, California 93405
1276
mi
from
San Luis Obispo, CA
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417
mi
from
St. Louis, MO
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