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A Study of Emibetuzumab in Non Small Cell Lung Cancer (NSCLC) Participants | Clinical Trials | Clareo Health

COMPLETEDPHASE2

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

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

NCT01900652•Eli Lilly and Company

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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

Locations (59)

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

Key Dates

Start Date

August 1, 2013

Primary Completion Date

February 1, 2015

Completion Date

March 1, 2016

Last Updated

September 18, 2019

Enrollment

111

ACTUAL participants

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Emibetuzumab

DRUG

Erlotinib

DRUG

A Study of JNJ-90301900 in Combination With Chemoradiation Followed by Consolidation Immunotherapy for Non-Small Cell Lung Cancer (NSCLC)

NCT06667908

Carcinoma, Non-Small-Cell Lung

View study

RECRUITING

KEYMAKER-U01 Umbrella Master Study: Studies of Investigational Agents With Either Pembrolizumab (MK-3475) Alone or With Pembrolizumab PLUS Chemotherapy in Participants With Non-small Cell Lung Cancer (NSCLC) (MK-3475-U01/KEYMAKER-U01)

NCT04165798

Carcinoma, Non-Small-Cell Lung

View study

RECRUITING

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 18, 2019Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

A Study of JNJ-90301900 in Combination With Chemoradiation Followed by Consolidation Immunotherapy for Non-Small Cell Lung Cancer (NSCLC)

KEYMAKER-U01 Umbrella Master Study: Studies of Investigational Agents With Either Pembrolizumab (MK-3475) Alone or With Pembrolizumab PLUS Chemotherapy in Participants With Non-small Cell Lung Cancer (NSCLC) (MK-3475-U01/KEYMAKER-U01)

A Study of Adagrasib Plus Pembrolizumab Plus Chemotherapy vs. Placebo Plus Pembrolizumab Plus Chemotherapy in Participants With Previously Untreated Non-squamous Non-small Cell Lung Cancer With KRAS G12C Mutation (KRYSTAL-4)

A Study of LY4175408 in Participants With Advanced Cancer

A Study to Learn About the Study Medicine Called PF-08634404 in Combination With Chemotherapy in Adult Participants With Locally Advanced or Metastatic Non-Small Cell Lung Cancer

A Study of Amivantamab in Combination With Lazertinib, or Amivantamab in Combination With Platinum-Based Chemotherapy, for Common Epidermal Growth Factor Receptor (EGFR)-Mutated Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC)