A Study of Sargramostim Plus Pembrolizumab With or Without Pemetrexed in Patients With Advanced Non-small Cell Lung Cancer After Chemoimmunotherapy

Program Overview

Lung cancer is the most common cancer worldwide and is the leading cause of cancer-related deaths. The survival rate for advanced lung cancer is very low, with less than 5% of patients surviving for five years. Recently, new treatments called PD-1 inhibitors, like pembrolizumab, have shown better results than traditional chemotherapy. However, there's still room for improvement, especially for patients with a specific type of lung cancer (stage 4 NSCLC) who don't have certain genetic changes and have low levels of a protein called PDL-1. This study aims to see if adding a drug called GM-CSF to pembrolizumab, with or without another drug called pemetrexed, can improve the effectiveness of the treatment during the maintenance phase after initial chemoimmunotherapy.

Description

Lung cancer is the most diagnosed cancer globally and the leading cause of cancer deaths. Advanced lung cancer has a very low survival rate, with less than 5% of patients living for five years. New treatments, like PD-1 inhibitors such as pembrolizumab, have improved survival rates compared to chemotherapy. These treatments work by blocking certain proteins that help cancer cells hide from the immune system. However, not all patients respond well to these treatments, especially those with low levels of a protein called PD-L1.

Patients with non-small cell lung cancer (NSCLC) can receive pembrolizumab alone or with chemotherapy, depending on their PD-L1 levels. Despite some success, there's a need to improve treatment responses for patients with stage 4 NSCLC who don't have specific genetic changes and have low PD-L1 levels.

Research suggests that combining GM-CSF, a growth factor that helps the immune system, with immunotherapy could be beneficial. GM-CSF is already approved for use by the FDA. A previous study in melanoma patients showed that adding GM-CSF to immunotherapy was safe and improved survival rates. This study will test if using GM-CSF with pembrolizumab, with or without pemetrexed, is safe and can improve treatment outcomes for advanced NSCLC patients with low PD-L1 levels. The goal is to establish a basis for further research on this combination treatment.

Eligibility Criteria