drugset / Trial / NCT04909034

A Randomized, Placebo Controlled Study to Evaluate the Safety and Potential Efficacy of MS-20 in Combination with Pembrolizumab for the Treatment of Non-Small-Cell Lung Cancer

NCT04909034 ↗

Completed 15 enrolled Microbio Co Ltd
RandomizedParallel-groupQuadruple-blindTreatment

Summary

MS-20 was approved as the first oral cancer adjuvant new drug indicated for ameliorating fatigue and appetite loss associated with cancer chemotherapy via reshaping human gut ecosystem and restoring immunity. MS-20 has also been shown to be anti-PD-1 booster by activating tumor-infiltrating lymphocytes (TILs) in mice cancer models, particularly promoting migration of TILs into tumors and increasing the amount of TILs inside tumors. Therefore, this study is designed to explore the potential clinical outcomes, safety and relationship between gut microbiome in NSCLC patients under combination therapy with pembrolizumab and MS-20.

Timeline

Start
2021-08-20
Primary completion
2024-10-23
Completion
2024-11-30

Drugs

EvaluationDrugModalityDoseRoute
Subject MS-20 Other / unclassified 4 ml Oral