Exploratory study to evaluate the combined effect of CBM588: Clostridium butyricum in platinum plus pemetrexed with pembrolizumab for non-small cell lung cancer-protocol of MIYABRO study

Background

Platinum plus pemetrexed and pembrolizumab is a standard first-line treatment for advanced or recurrent non-squamous non-small cell lung cancer (NSCLC) without actionable driver alterations, including tumors with a programmed death-ligand 1 (PD-L1) tumor proportion score (TPS) <50%. However, the clinical benefits vary, and biomarkers for this chemoimmunotherapy regimen remain limited. CBM588, a live biotherapeutic preparation containing Clostridium butyricum MIYAIRI, may modulate antitumor immunity by affecting the gut microbiota. The MIYABRO study aims to evaluate the additive efficacy and safety of CBM588 with platinum plus pemetrexed and pembrolizumab and to explore longitudinal gut microbiota dynamics.