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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

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ClinicalTrials.gov Identifier: NCT01887886
Recruitment Status : Completed
First Posted : June 27, 2013
Last Update Posted : November 2, 2016
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

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.

Condition or disease Intervention/treatment Phase
Non-Squamous Non-Small Cell Lung Cancer Drug: erlotinib Drug: onartuzumab Drug: placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : December 2013
Actual Primary Completion Date : February 2015
Actual Study Completion Date : February 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Onartuzumab + Erlotinib Drug: erlotinib
150 mg orally daily

Drug: onartuzumab
15 mg/kg IV every 3 weeks

Active Comparator: Placebo + Erlotinib Drug: erlotinib
150 mg orally daily

Drug: placebo
IV every 3 weeks




Primary Outcome Measures :
  1. Progression-free survival (investigator-assessed according to RECIST v1.1) [ Time Frame: approximately 3 years ]

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


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01887886


Locations
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United States, California
Bakersfield, California, United States, 93309
Fullerton, California, United States, 92835
Long Beach, California, United States, 90813
Los Angeles, California, United States, 90095-1772
Los Angeles, California, United States, 90095
San Luis Obispo, California, United States, 93454
United States, Florida
Fort Myers, Florida, United States, 33905
Orlando, Florida, United States, 32803
Saint Petersburg, Florida, United States, 33705
United States, Illinois
Chicago, Illinois, United States, 60637
United States, Louisiana
Marrero, Louisiana, United States, 70072
Metairie, Louisiana, United States, 70006
United States, Missouri
St. Louis, Missouri, United States, 63110
United States, Ohio
Canton, Ohio, United States, 44718
United States, Tennessee
Nashville, Tennessee, United States, 37203
France
Caen, France, 14076
Lyon, France, 69373
Nantes, France, 44805
Germany
Grosshansdorf, Germany, 22927
Oldenburg, Germany, 26121
Villingen-Schwenningen, Germany, 78052
Japan
Ehime, Japan, 791-0280
Okayama, Japan, 700-8558
Yamaguchi, Japan, 755-0241
Korea, Republic of
Gwangju, Korea, Republic of, 501-757
Suwon-si,, Korea, Republic of, 442-723
Malaysia
Tanjung Bungah, Malaysia, 11200
Spain
Barcelona, Spain, 08025
Barcelona, Spain, 08035
Madrid, Spain, 28007
Madrid, Spain, 28050
Madrid, Spain, 28222
Taiwan
Taichung, Taiwan, 40447
Taipei, Taiwan, 00112
Taipei, Taiwan, 100
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
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Study Director: Clinical Trials Hoffmann-La Roche
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Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01887886    
Other Study ID Numbers: GO28758
2013-000868-29 ( EudraCT Number )
First Posted: June 27, 2013    Key Record Dates
Last Update Posted: November 2, 2016
Last Verified: November 2016
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Erlotinib Hydrochloride
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action