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
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
2 other identifiers
interventional
10
8 countries
35
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Dec 2013
Shorter than P25 for phase_3
35 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 25, 2013
CompletedFirst Posted
Study publicly available on registry
June 27, 2013
CompletedStudy Start
First participant enrolled
December 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2015
CompletedNovember 2, 2016
November 1, 2016
1.2 years
June 25, 2013
November 1, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Progression-free survival (investigator-assessed according to RECIST v1.1)
approximately 3 years
Secondary Outcomes (6)
Overall survival
approximately 3 years
Overall response rate
approximately 3 years
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
Safety: Incidence of adverse events
approximately 3 years
- +1 more secondary outcomes
Study Arms (2)
Onartuzumab + Erlotinib
EXPERIMENTALPlacebo + Erlotinib
ACTIVE COMPARATORInterventions
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (35)
Unknown Facility
Bakersfield, California, 93309, United States
Unknown Facility
Fullerton, California, 92835, United States
Unknown Facility
Long Beach, California, 90813, United States
Unknown Facility
Los Angeles, California, 90095-1772, United States
Unknown Facility
Los Angeles, California, 90095, United States
Unknown Facility
San Luis Obispo, California, 93454, United States
Unknown Facility
Fort Myers, Florida, 33905, United States
Unknown Facility
Orlando, Florida, 32803, United States
Unknown Facility
St. Petersburg, Florida, 33705, United States
Unknown Facility
Chicago, Illinois, 60637, United States
Unknown Facility
Marrero, Louisiana, 70072, United States
Unknown Facility
Metairie, Louisiana, 70006, United States
Unknown Facility
St Louis, Missouri, 63110, United States
Unknown Facility
Canton, Ohio, 44718, United States
Unknown Facility
Nashville, Tennessee, 37203, United States
Unknown Facility
Caen, 14076, France
Unknown Facility
Lyon, 69373, France
Unknown Facility
Nantes, 44805, France
Unknown Facility
Großhansdorf, 22927, Germany
Unknown Facility
Oldenburg, 26121, Germany
Unknown Facility
Villingen-Schwenningen, 78052, Germany
Unknown Facility
Ehime, 791-0280, Japan
Unknown Facility
Okayama, 700-8558, Japan
Unknown Facility
Yamaguchi, 755-0241, Japan
Unknown Facility
Tanjung Bungah, 11200, Malaysia
Unknown Facility
Gwangju, 501-757, South Korea
Unknown Facility
Suwon, 442-723, South Korea
Unknown Facility
Barcelona, Barcelona, 08025, Spain
Unknown Facility
Barcelona, Barcelona, 08035, Spain
Unknown Facility
Madrid, Madrid, 28007, Spain
Unknown Facility
Madrid, Madrid, 28050, Spain
Unknown Facility
Madrid, Madrid, 28222, Spain
Unknown Facility
Taichung, 40447, Taiwan
Unknown Facility
Taipei, 00112, Taiwan
Unknown Facility
Taipei, 100, Taiwan
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Clinical Trials
Hoffmann-La Roche
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 25, 2013
First Posted
June 27, 2013
Study Start
December 1, 2013
Primary Completion
February 1, 2015
Study Completion
February 1, 2015
Last Updated
November 2, 2016
Record last verified: 2016-11