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

Hoffmann-La Roche0 sites10 target enrollmentDecember 2013

ConditionsNon-Squamous Non-Small Cell Lung Cancer

Interventionserlotinib onartuzumab placebo

Overview

Phase: Phase 3
Intervention: erlotinib
Conditions: Non-Squamous Non-Small Cell Lung Cancer
Sponsor: Hoffmann-La Roche
Enrollment: 10
Primary Endpoint: Progression-free survival (investigator-assessed according to RECIST v1.1)
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

December 2013

End Date

February 2015

Last Updated

9 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Hoffmann-La Roche

Responsible Party

Sponsor

Eligibility Criteria

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

Arms & Interventions

Onartuzumab + Erlotinib

Intervention: erlotinib

Onartuzumab + Erlotinib

Intervention: onartuzumab

Placebo + Erlotinib

Intervention: erlotinib

Placebo + Erlotinib

Intervention: placebo

Outcomes

Primary Outcomes

Progression-free survival (investigator-assessed according to RECIST v1.1)

Time Frame: approximately 3 years

Secondary Outcomes

Time to deterioration (>/= 10 points [transformed score] from baseline) in patient-reported lung cancer symptoms(approximately 3 years)
Patient reported outcomes: HRQoL/EORTC QLC-C30/EORTC QLQ-LC31 questionnaires(approximately 3 years)
Overall survival(approximately 3 years)
Pharmacokinetics: Area under the concentration-time curve (AUC)(Day 1 Cycles 1, 2 and 4)
Overall response rate(approximately 3 years)
Safety: Incidence of adverse events(approximately 3 years)