A Study of Emibetuzumab in Non Small Cell Lung Cancer (NSCLC) Participants
NCT ID: NCT01900652
Last Updated: 2019-09-18
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
111 participants
INTERVENTIONAL
2013-08-31
2016-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Arm A: Emibetuzumab plus Erlotinib
750 milligram (mg) Emibetuzumab flat dose given as a 1.5 hour intravenous (IV) infusion on Days 1 and 15 of a 28-day cycle and Erlotinib 150 mg given orally once daily on a 28-day cycle.
Emibetuzumab
Administered IV
Erlotinib
Administered Orally
Arm B: Emibetuzumab
750 mg Emibetuzumab flat dose given as a 1.5-hour IV infusion on Days 1 and 15 of a 28-day cycle.
Emibetuzumab
Administered IV
Interventions
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Emibetuzumab
Administered IV
Erlotinib
Administered Orally
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* At least 1 measurable extra-central nervous system (CNS) lesion
* Documented radiographic progression while on continuous treatment with erlotinib monotherapy
* Objective clinical benefit from erlotinib treatment as defined by either documented partial or complete response or stable disease ≥6 months or, if most recent erlotinib treatment has been initiated based on documented epidermal growth factor receptor mutation (EGFRmt) status, at least 12 weeks stable disease
* Determined to be MET diagnostic positive (+)
* Availability of a tumor sample post-erlotinib progression
* Eastern Cooperative Oncology Group (ECOG) performance status ≤2
* Have adequate organ function
Exclusion Criteria
* Have previously been treated with LY2875358 or any other MET-targeting experimental therapeutic
* Have a serious concomitant systemic disorder or significant cardiac disease
* Have interstitial pneumonia or interstitial fibrosis of the lung or have pleural effusion, pericardial fluids or ascites, requiring drainage every other week or more frequently
* Have a history of another malignancy except for basal or squamous cell skin cancer and/or in situ carcinoma of the cervix, or other solid tumors treated curatively and without evidence of recurrence for at least 3 years prior to the study
* Have major surgery less than 2 weeks prior initiation of study treatment therapy
* Pregnant or lactating women
* Have symptomatic CNS metastasis
18 Years
ALL
No
Sponsors
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Eli Lilly and Company
INDUSTRY
Responsible Party
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Principal Investigators
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Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
Role: STUDY_DIRECTOR
Eli Lilly and Company
Locations
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University of Alabama at Birmingham
Birmingham, Alabama, United States
University of California - San Diego
La Jolla, California, United States
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Los Angeles, California, United States
University of California, Davis - Health Systems
Sacramento, California, United States
UCLA
Santa Monica, California, United States
University of Colorado Health Sciences Center
Aurora, Colorado, United States
Georgetown University Medical Center IRB
Washington D.C., District of Columbia, United States
Florida Cancer Specialists
Fort Myers, Florida, United States
Florida Cancer Specialists
St. Petersburg, Florida, United States
H Lee Moffitt Cancer Center
Tampa, Florida, United States
Northeast Georgia Cancer Care, LLC
Athens, Georgia, United States
Emory University
Atlanta, Georgia, United States
University of Iowa Hospital
Iowa City, Iowa, United States
University of Kansas Medical Center
Westwood, Kansas, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Karmanos Cancer Institute
Detroit, Michigan, United States
Mayo Clinic
Rochester, Minnesota, United States
Washington University Medical Center
St Louis, Missouri, United States
Billings Clinic Research Center
Billings, Montana, United States
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, United States
Columbia University
New York, New York, United States
Carolinas Medical Center
Charlotte, North Carolina, United States
Oncology Hematology Care Inc
Cincinnati, Ohio, United States
Portland VA Medical Center
Portland, Oregon, United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States
Tennessee Oncology PLLC
Chattanooga, Tennessee, United States
The West Clinic
Memphis, Tennessee, United States
Tennessee Oncology PLLC
Nashville, Tennessee, United States
MS Center at Evergreen
Kirkland, Washington, United States
Seattle Cancer Care Alliance
Seattle, Washington, United States
Group Health
Seattle, Washington, United States
Multicare Health System
Tacoma, Washington, United States
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Aalst, , Belgium
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Ghent, , Belgium
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Mechelen, , Belgium
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Roeselare, , Belgium
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Montpellier, , France
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Toulouse, , France
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Heidelberg, , Germany
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Ulm, , Germany
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Beersheba, , Israel
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Jerusalem, , Israel
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Kfar Saba, , Israel
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Petah Tikva, , Israel
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Tel Litwinsky, , Israel
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Ẕerifin, , Israel
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Milan, , Italy
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Orbassano, , Italy
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Amsterdam, , Netherlands
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Breda, , Netherlands
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Seoul, , South Korea
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Badalona, , Spain
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Pamplona, , Spain
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Valencia, , Spain
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Bristol, Avon, United Kingdom
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London, Greater London, United Kingdom
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Southampton, Hants, United Kingdom
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Wythenshawe, Manchester, United Kingdom
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Headington, Oxford, United Kingdom
Countries
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Other Identifiers
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I4C-MC-JTBC
Identifier Type: OTHER
Identifier Source: secondary_id
14208
Identifier Type: -
Identifier Source: org_study_id
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