Phase 2 Trial of SBRT and Gene Therapy Prior to Nivolumab for NSCLC
Researchers are evaluating whether patients with metastatic NSCLC will benefit from stereotactic body radiation and a virally mediated gene therapy prior to nivolumab.
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.
- 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.