A Study of Emibetuzumab in Non Small Cell Lung Cancer (NSCLC) Participants
Chime
A Randomized, Open-Label Phase 2 Study Evaluating LY2875358 Plus Erlotinib and LY2875358 Monotherapy in MET Diagnostic Positive NSCLC Patients With Acquired Resistance to Erlotinib
2 other identifiers
interventional
111
10 countries
59
Brief Summary
The primary purpose of this study is to evaluate the efficacy of the study drug known as LY2875358, administered alone or in combination with a second drug named Erlotinib, in participants affected by a defined type of lung cancer (MET biomarker diagnostic positive Non-Small-Cell Lung Cancer) that experienced a disease progression during the most recent treatment with Erlotinib.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Aug 2013
59 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 12, 2013
CompletedFirst Posted
Study publicly available on registry
July 16, 2013
CompletedStudy Start
First participant enrolled
August 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
March 1, 2016
CompletedResults Posted
Study results publicly available
June 25, 2018
CompletedSeptember 18, 2019
September 1, 2019
1.5 years
July 12, 2013
March 24, 2018
September 6, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Percentage of Participants Achieving Complete Response (CR) or Partial Response (PR) (Overall Response Rate [ORR])
ORR is confirmed best overall tumor response of CR or PR. According to RECIST v1.1, CR was defined as the disappearance of all target and non-target lesions; PR defined as a \>30% decrease in the sum of the longest diameters (LD) of the target lesions, taking as reference the baseline sum of the LD. Percentage of participants was calculated as: (total number of participants with CR or PR from start of the treatment until disease progression or recurrence)/total number of participants treated) \* 100.
Baseline to Objective Disease Progression or Start of New Anticancer Therapy (Up to 15 Months)
Secondary Outcomes (11)
Progression Free Survival (PFS)
Baseline to Objective Disease Progression or Death (Up to 24 Months)
Time to Progressive Disease
Baseline to Objective Disease Progression (Up to 24 Months)
Change in Tumor Size (CTS)
Baseline to Measurement with Smallest Tumor Size (Up to 24 Months)
Secondary: Percentage of Participants Who Achieved Best Overall Disease Response of CR, PR or Stable Disease (SD) [Disease Control Rate (DCR)]
Baseline to Objective Disease Progression or Participant Stops Study (Up to 24 Months)
Duration of Response (DoR)
Date of CR or PR to Date of Objective Disease Progression or Death Due to Any Cause (Up to 24 Months)
- +6 more secondary outcomes
Study Arms (2)
Arm A: Emibetuzumab plus Erlotinib
EXPERIMENTAL750 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.
Arm B: Emibetuzumab
EXPERIMENTAL750 mg Emibetuzumab flat dose given as a 1.5-hour IV infusion on Days 1 and 15 of a 28-day cycle.
Interventions
Administered IV
Eligibility Criteria
You may qualify if:
- Diagnosis of metastatic Stage IV NSCLC
- 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
You may not qualify if:
- Are currently enrolled in, or discontinued within the last 30 days from, a clinical trial involving an investigational product or non-approved use of a drug or device
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (59)
University of Alabama at Birmingham
Birmingham, Alabama, 35294, United States
University of California - San Diego
La Jolla, California, 92037, 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, 90048, United States
University of California, Davis - Health Systems
Sacramento, California, 95817, United States
UCLA
Santa Monica, California, 90404, United States
University of Colorado Health Sciences Center
Aurora, Colorado, 80045, United States
Georgetown University Medical Center IRB
Washington D.C., District of Columbia, 20007, United States
Florida Cancer Specialists
Fort Myers, Florida, 33916-2233, United States
Florida Cancer Specialists
St. Petersburg, Florida, 33705, United States
H Lee Moffitt Cancer Center
Tampa, Florida, 33612, United States
Northeast Georgia Cancer Care, LLC
Athens, Georgia, 30607, United States
Emory University
Atlanta, Georgia, 30322, United States
University of Iowa Hospital
Iowa City, Iowa, 52242, United States
University of Kansas Medical Center
Westwood, Kansas, 66205, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Karmanos Cancer Institute
Detroit, Michigan, 48201, United States
Mayo Clinic
Rochester, Minnesota, 55905, United States
Washington University Medical Center
St Louis, Missouri, 63110, United States
Billings Clinic Research Center
Billings, Montana, 59101, United States
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, 03756, United States
Columbia University
New York, New York, 10032, United States
Carolinas Medical Center
Charlotte, North Carolina, 28204, United States
Oncology Hematology Care Inc
Cincinnati, Ohio, 45242, United States
Portland VA Medical Center
Portland, Oregon, 97213, United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111, United States
Tennessee Oncology PLLC
Chattanooga, Tennessee, 37404, United States
The West Clinic
Memphis, Tennessee, 38120, United States
Tennessee Oncology PLLC
Nashville, Tennessee, 37203, United States
MS Center at Evergreen
Kirkland, Washington, 98034, United States
Seattle Cancer Care Alliance
Seattle, Washington, 98109, United States
Group Health
Seattle, Washington, 98112, United States
Multicare Health System
Tacoma, Washington, 98405, 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, 9300, Belgium
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.
Ghent, 9000, Belgium
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.
Mechelen, 2800, Belgium
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Roeselare, 8800, Belgium
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Montpellier, 34295, France
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Toulouse, 31059, France
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.
Heidelberg, 69126, Germany
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Ulm, 89081, Germany
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.
Beersheba, 84101, Israel
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.
Jerusalem, 91120, Israel
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Kfar Saba, 44281, Israel
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.
Petah Tikva, 49100, Israel
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.
Tel Litwinsky, 52621, Israel
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Ẕerifin, 6093000, Israel
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Milan, 20052, Italy
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.
Orbassano, 10043, Italy
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.
Amsterdam, 1081 HV, Netherlands
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.
Breda, 4818 CK, Netherlands
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.
Seoul, 138-736, South Korea
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Badalona, 08916, Spain
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.
Pamplona, 31008, Spain
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.
Valencia, 46026, Spain
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.
Bristol, Avon, BS10 5NB, 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.
London, Greater London, W6 8RF, 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.
Southampton, Hants, SO16 6YD, 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, M23 9LT, 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, OX3 7LE, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Chief Medical Officer
- Organization
- Eli Lilly and Company
Study Officials
- STUDY DIRECTOR
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)
Eli Lilly and Company
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 12, 2013
First Posted
July 16, 2013
Study Start
August 1, 2013
Primary Completion
February 1, 2015
Study Completion
March 1, 2016
Last Updated
September 18, 2019
Results First Posted
June 25, 2018
Record last verified: 2019-09
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
- Access Criteria
- A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.