Phase 2 Trial of SBRT and Gene Therapy Prior to Nivolumab for NSCLC

Title: 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 Carcinoma¹

Principal Investigator: Eric Bernicker, MD, Houston Methodist Cancer Center

Description: For this open-label phase 2 study (ClinicalTrials.gov Identifier: NCT02831933), researchers are evaluating whether patients with metastatic non–small cell lung cancer (NSCLC) will benefit from stereotactic body radiation (SBRT) and a virally mediated gene therapy prior to nivolumab.

The gene therapy injections will contain “adenovirus-mediated expression of herpes simplex virus thymidine kinase (ADV/HSV-tk).” Patients will also receive valacyclovir, an antiviral used to treat HSV.

Patients will receive ADV/HSV-tk on day 0, valacyclovir from days 1 through 15, SBRT from days 2 through 16, and nivolumab 240 mg started day 17.

The primary outcome is overall response rate; secondary outcomes include duration of response, overall survival, and progression-free survival.

For more study information, including inclusion and exclusion criteria, study locations, and contact information, visit https://clinicaltrials.gov/ct2/show/NCT02831933.

Status: This study is open and recruiting patients as of December 15, 2017.

This study is sponsored by Eric Bernicker, MD.

Reference

1. Clinicaltrials.gov. Trial of stereotactic body radiation and gene therapy before nivolumab for metastatic non-small cell lung carcinoma (ENSIGN). NCT02831933. https://clinicaltrials.gov/ct2/show/NCT02831933. Accessed December 15, 2017.