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

Roche

Status and phase

Completed

Phase 3

Conditions

Non-Squamous Non-Small Cell Lung Cancer

Treatments

Drug: placebo

Drug: erlotinib

Drug: onartuzumab

Study type

Interventional

Funder types

Industry

Identifiers

NCT01887886

GO28758

2013-000868-29 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment

10 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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