KEYMAKER-U01 Study Testing Pembrolizumab Alone or With Chemotherapy and Other Agents in Adults With Non-Small Cell Lung Cancer

What this Trial Is About

Researchers are conducting an umbrella master protocol study to evaluate pembrolizumab MK-3475 in the treatment of non-small cell lung cancer NSCLC. This study includes multiple substudies that enroll different groups of NSCLC participants, covering various stages and treatment histories. The study aims to investigate the combination of pembrolizumab with other investigational agents and chemotherapy in different NSCLC populations. Participants may undergo tumor imaging using MRI or CT scans, tumor tissue collection if no archival samples are available, and blood sample collection for detailed genetic and biomarker analysis. The substudies involve treatment-naive patients, previously treated patients, and those with specific genetic mutations, with therapies administered alone or in combination in rolling arms. During the study, participants are screened and evaluated through imaging and tissue collection procedures. Researchers will measure outcomes such as PD-L1 tumor expression levels and tumor histology status within approximately one month. The study involves detailed monitoring of tumor characteristics and biomarkers to understand treatment responses, with participation potentially lasting up to several years until study completion.

KEYMAKER-U01 Umbrella Master Study: Studies of Investigational Agents With Either Pembrolizumab (MK-3475) Alone or With Pembrolizumab PLUS Chemotherapy in Participants With Non-small Cell Lung Cancer (NSCLC) (MK-3475-U01/KEYMAKER-U01)