Study ID: ImmunityBio Inc. Quilt 2.023


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).

Title: “QUILT 2.023: A PHASE 2, OPEN-LABEL, RANDOMIZED STUDY OF ALT-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 METASTATIC NON-SMALL CELL LUNG CANCER (NSCLC)”. Study Description: In this research study, you will receive a novel immunostimulatory protein complex called ALT-803 via subcutaneous injection either alone, or in combination with pembrolizumab via infusion. Both study treatment periods will consist of repeated 3-week cycles for a maximum study treatment period of 2 years. The purpose of this study is to determine the effectiveness and safety profile of combination therapy with ALT-803 and pembrolizumab, versus pembrolizumab alone, as first-line treatment for patients who have metastatic NSCLC in which pembrolizumab is indicated for first-line treatment.
Sioux Falls Region
Principal Investigator:
Christopher Sumey, MD
Non-Small Cell Lung Cancer
Phase II
Active - Open to Accrual