CompletedPhase 2NCT01900652

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

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.

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

StatusCompleted
PhasePhase 2
U.S. locations59
SponsorEli Lilly and Company
01
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
02
Explore related studies

How this study is categorized

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

03
Public criteria

Who may be able to participate

Inclusion 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 Exclusion 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.

04
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 ↗