998-19 | QUILT 2.023: A Study of N-803 in Combination With Current Standard of Care vs Standard of Care as First-Line Treatment for Patients With Stage 3 or 4 Non-small Cell Lung Cancer (NSCLC).

Overview

“A Phase 2, Open-label, Randomized Study of N-803, a Fusion Protein Activator of Natural Killer and T cells, in Combination with Pembrolizumab vs Pembrolizumab Alone as First-line Treatment for Patients with Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC)”

Lung cancer is the leading cause of cancer worldwide and is responsible for roughly 1 in 5 cancer deaths, totaling approximately 1.59 million annual deaths. Lung cancers can be histologically classified into small cell lung cancer and NSCLC. NSCLC is an umbrella category, encompassing any lung cancer that is not small cell lung cancer, which is thought to arise from neuroendocrine cells in the lung. NSCLC comprises roughly 85% of lung cancers and the prognosis for patients diagnosed with advanced NSCLC remains poor. Despite the recent successes achieved with immunotherapy treatment, there is a clear unmet medical need for patients with advanced NSCLC. Preclinical studies suggest that combination treatment combining checkpoint inhibition and IL-15 stimulation may increase anti-tumor activity. This is a phase 2, open-label, randomized study to compare the safety and efficacy of combination therapy with N-803 and pembrolizumab (experimental arm) versus pembrolizumab alone (control arm), as first-line treatment for subjects with stage 3 NSCLC or stage 4 NSCLC, for which pembrolizumab is indicated for first-line treatment. In summary, the study will compare treatment with the anti-PD-1 checkpoint inhibitor pembrolizumab in combination with the IL-15 superagonist N-803 vs treatment with pembrolizumab alone.