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

Location:

Rochester, Minn., Phoenix/Scottsdale, Ariz.

Trial status:

Open for Enrollment

Why is this study being done?

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.

Who is eligible 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

Last updated:

7/29/2014

NCT ID:

NCT01900652

IRB Number:

13-001902