Summary
This phase II/III Lung-MAP trial compares the effect of combination immunotherapy with N-803 (ALT-803) and pembrolizumab versus usual treatment (docetaxel, gemcitabine, pemetrexed, or ramucirumab combined with docetaxel) in patients with non-small cell lung cancer (NSCLC) previously treated with anti-PD-1 or anti-PD-L1 immunotherapy and whose tumor has spread to other places in the body (advanced). N-803 (ALT-803) binds to and activates certain immune cells (natural killer cells and specific T cells). By doing this N-803 may increase tumor cell killing and decrease tumor growth. Chemotherapy drugs, such as docetaxel, gemcitabine, pemetrexed, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Ramucirumab is a monoclonal antibody that may prevent the growth of new blood vessels that tumors need to grow. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. This study will help to understand whether combination immunotherapy with N-803 and pembrolizumab is better, the same, or worse than the usual approach in treating patients with recurrent NSCLC who previously received anti-PD-1 or anti-PD-L1 immunotherapy.