Non-Small Cell Lung Cancer
Lung cancer is the leading cause of cancer death in the United States, with about 150,000 deaths annually. About 90 percent of cases of lung cancer are one of the three major forms of non-small cell lung cancer. The five-year survival rate of lung cancer patients is about 17 percent although this is expected to improve dramatically with the introduction of checkpoint inhibitors treatments such as anti-PD1 therapies Opdivo® and Keytruda® that have demonstrated RECIST complete response rates in clinical trials of 10-25 percent. Nevertheless, for those non-responsive to checkpoint therapy – the vast majority of patients – there remains a dire need for effective treatments.
LuTK02: GMCI plus Standard of Care Immune Checkpoint Inhibitor for Stage III/IV Non-Small Cell Lung Cancer (NSCLC) Patients
A previous study, LuTK01, showed that endobronchial delivery of AdV-tk to lung tumors was feasible and well tolerated. As a result, a phase 2 multi-site trial of GMCI is proposed to evaluate the safety and efficacy of adding GMCI to standard of care in patients with stage III/IV NSCLC that are not responding to a first line immune checkpoint inhibitor (ICI). Patients will be divided into three cohorts and receive two courses of AdV-tk injected into an accessible involved tumor site (lung nodule, lymph node disease or peripheral metastasis) followed by 14 days of oral valacyclovir. Patients will continue with ICI +/- chemotherapy. This LuTK02 study follows on very promising results from earlier clinical Lung studies using GMCI. The intent of the study is to determine if the combination of GMCI and ICI may improve the response rate and overall clinical long-term benefit for NSCLC patients.