ENSIGN: Phase II Window of Opportunity Trial of Stereotactic Body Radiation Therapy and In Situ Gene Therapy Followed by Nivolumab in Metastatic Squamous or Non-Squamous Non-Small Cell Lung Carcinoma

Investigator: Eric Bernicker, MD

Study Coordinator: Georgia Michou

Status: Enrolling

ClinicalTrials.gov Number: NCT02831933

Phone: 713.441.1952

Protocol Number: Pro00014976


This is a Phase II trial to determine the efficacy and safety of in situ gene therapy and stereotactic body radiation therapy (SBRT) used as a window of opportunity treatment before nivolumab in patients with metastatic squamous and non-squamous non-small cell lung carcinoma (NSCLC). In situ gene therapy will consist of adenovirus-mediated expression of herpes simplex virus thymidine kinase (ADV/HSV-tk) plus Valacyclovir therapy.
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