A Study of LY2875358 in Non Small Cell Lung Cancer (NSCLC) Participants

Status: Recruiting
Phase: Phase 2
Diagnosis: Lung Cancer
NCT ID: NCT01900652 (View complete trial on ClinicalTrials.gov)
DFCI Protocol ID:


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.


Conducting Institutions:
Brigham and Women's Hospital, Dana-Farber Cancer Institute, Massachusetts General Hospital

Overall PI:
Pasi Janne, MD, PhD, Dana-Farber Cancer Institute

Site-responsible Investigators:
Lecia Sequist, MD, Massachusetts General Hospital

Dana-Farber Cancer Institute: Kelly Masone, 617-632-3383, kmasone@partners.org
Massachusetts General Hospital: Cancer Trials Call Center, 877-789-6100

Eligibility 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
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