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

Study 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.

Ask AI to explain this study

Start here

Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedEmibetuzumab and Erlotinib

The study team can explain what participation involves.

Who it may be forNon-small cell lung cancer (NSCLC) · MET

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Sep 18, 2019 · Source: ClinicalTrials.gov

Is enrollment open?Completed

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 2

Interventional

Where is it offered?59 U.S. locations

Locations may change over time.

Who runs it?Eli Lilly and Company

Study sponsor

Study overview

What this study is about

Purpose: Treatment
Study type: Interventional
Phase: Phase 2
Sponsor: Eli Lilly and Company
Interventions being studied: Drug: Emibetuzumab; Drug: Erlotinib

Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

Cancer type

Non-small cell lung cancer (NSCLC)→

Biomarkers

MET→

Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion criteria

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

Reasons someone may not be able to joinExclusion criteria

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

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

Study sites

U.S. locations

University of Alabama at BirminghamBirmingham, Alabama
University of California - San DiegoLa Jolla, California
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
University of California, Davis - Health SystemsSacramento, California
UCLASanta Monica, California
University of Colorado Health Sciences CenterAurora, Colorado
Georgetown University Medical Center IRBWashington D.C., District of Columbia
Florida Cancer SpecialistsFort Myers, Florida
Florida Cancer SpecialistsSt. Petersburg, Florida
H Lee Moffitt Cancer CenterTampa, Florida
Northeast Georgia Cancer Care, LLCAthens, Georgia
Emory UniversityAtlanta, Georgia

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Sep 18, 2019. Always confirm current availability with the study team.

View original record ↗