A Study of Emibetuzumab in Non Small Cell Lung Cancer (NSCLC) Participants

Completed · Phase 2

Conditions studied: Carcinoma, Non-Small-Cell Lung

In brief

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.

Key facts

Study ID

NCT01900652

Run by

Eli Lilly and Company

People needed

111

Starts

2013-08-01

Expected to finish

2016-03-01

Last updated by the study team

2019-09-18

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

• 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
• University of Alabama at Birmingham — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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