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

• Status: Completed
• Trial end date: 2016-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Eli Lilly and Company
• Treatments: Erlotinib Hydrochloride

Criteria

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