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

Completed · Phase 3 · Has a placebo group

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

In brief

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.

Key facts

Study ID

NCT01887886

Run by

Hoffmann-La Roche

People needed

10

Starts

2013-12-01

Expected to finish

2015-02-01

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 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

You may not qualify if…

• 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

Where it is running

• Study site — Bakersfield, California, United States
• Study site — Fullerton, California, United States
• Study site — Long Beach, California, United States
• Study site — Los Angeles, California, United States
• Study site — Los Angeles, California, United States
• Study site — San Luis Obispo, California, United States
• Study site — Fort Myers, Florida, United States
• Study site — Orlando, Florida, United States
• Study site — St. Petersburg, Florida, United States
• Study site — Chicago, Illinois, United States
• Study site — Marrero, Louisiana, United States
• Study site — Metairie, Louisiana, United States
• Study site — St Louis, Missouri, United States
• Study site — Canton, Ohio, United States
• Study site — Nashville, Tennessee, United States
• Study site — Caen, France
• Study site — Lyon, France
• Study site — Nantes, France
• Study site — Großhansdorf, Germany
• Study site — Oldenburg, Germany
• Study site — Villingen-Schwenningen, Germany
• Study site — Ehime, Japan
• Study site — Okayama, Japan
• Study site — Yamaguchi, Japan
• Study site — Tanjung Bungah, Malaysia

Full record on ClinicalTrials.gov

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