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 |
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.
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
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