Ignite Creation Date:
2025-12-25 @ 2:37 AM
Ignite Modification Date:
2025-12-26 @ 7:00 PM
Study NCT ID:
NCT04909034
Status:
COMPLETED
Last Update Posted:
2024-12-18
First Post:
2021-05-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
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
Sponsor:
Microbio Co Ltd
Organization:
Study Overview
Official Title:
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
Status:
COMPLETED
Status Verified Date:
2024-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: