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

• 1 other identifier: MB103CLAS08
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 7

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.

Conditions

NSCLC Stage IIIB~IV

Keywords

NSCLC; MS-20; Add-on; pembrolizumab; metastatic; microbiome; microbiota

Outcome Measures

Primary Outcomes (1)

• To evaluate the objective response rate (ORR) in subjects with metastatic non-small cell lung cancer (NSCLC) treated with MS-20 combined with pembrolizumab.

  According to RECIST 1.1, the objective response rate (ORR) assessed by contrast is defined as the proportion of patients whose tumors shrink to a predetermined amount and remain for a period of time, which is the sum of complete response (CR) and partial response (PR).

  48 weeks

Secondary Outcomes (4)

• Progression free survival (PFS)

  48 weeks

• Disease control rate (DCR)

  48 weeks

• Duration of response (DOR)

  48 weeks

• Safety assessment- incidence of adverse events (TEAEs)

  48 weeks

Other Outcomes (2)

• To evaluate the effect on the gut microbiota in subjects with metastatic non-small cell lung cancer treated with MS-20 combined with pembrolizumab.

  48 weeks

• Safety

  48 weeks

Study Arms (2)

MS-20 oral solution

EXPERIMENTAL

Oral Solution 4 c.c, divided twice daily (BID) for 48 weeks.

Drug: MS-20

Placebo

PLACEBO COMPARATOR

Oral Solution 4 c.c, divided twice daily (BID) for 48 weeks.

Drug: Placebo

Interventions

MS-20 DRUG

Fermented soybean extract MicrSoy-20(MS-20), which uses a variety of lactic acid bacteria and yeasts to metabolize organic soybeans

Also known as: Chemo young

MS-20 oral solution

Placebo DRUG

Oral solution without active ingredients

Placebo

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female subjects who are over 20 years old (inclusive) at the time of signing the informed consent form.
• The subject is diagnosed pathologically or cytologically with non-small cell lung cancer (NSCLC).
• According to the 8th edition of the American Joint Committee on Cancer \[AJCC\], staging is metastatic III.B-IV NSCLC that cannot be surgically removed.
• The subject with metastatic non-squamous carcinoma whose EGFR/ALK/ROS 1 tumor gene is the original type, or subject with squamous cell carcinoma whose EGFR/ALK tumor gene is the original type.
• At least one measurable lesion per RECIST v 1.1 criteria.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
• The subject whose biomarker performance: The PD L1 performance detected by Dako 22C3 or Ventana SP263 and other third-level in vitro diagnostic medical devices (class III) must meet tumor proportion scores (TPS) ≥ 50%.
• The life expectancy is not less than 3 months.
• The subject whose liver and kidney functions must meet all of the following conditions:
• Liver function: aspartate aminotransferase (AST) value \< 2.5 x ULN, alanine aminotransferase (ALT) value \< 2.5 x ULN and total bilirubin (T-bilirubin) value \< 1.5 x ULN. For the subjects who have liver metastases, total bilirubin value should be \< 5 x ULN.
• Kidney function: Serum creatinine value \< 1.5 ULN. If subject's serum creatinine value is ≥ 1.5 x ULN, his/her creatinine clearance value should be \> 40 mL/min based on Cockcroft and Gault formula.
• Subject, if female of child-bearing potential, must agree to avoid sexual intercourse or be willing to use 2 medically accepted methods of contraception (e.g., Intra-uterine device or contraceptives) during the study. 【The definition of infertile：(1) Being menopause for more than 1 year；(2) Surgery for permanent contraception (e.g., abdominal tubal sterilization, bilateral Salpingooophorectomy, and tubectomy)；(3) Congenital structural abnormalities.】
• Subject, if male, agrees not to donate sperm, be willing to avoid sexual intercourse or use appropriate contraception method (e.g., using condom) during the study treatment period.
• Subject is active and capable to communicate with site staff, willing to be in compliance with the following two items based on investigator's judgment.
• To complete return visits and study examination per the study protocol.

You may not qualify if:

• Presence of any symptomatic central nervous system metastasis or leptomeningeal metastasis.
• Presence of any other malignant tumor. Unless the subject had completed radical treatment without any disease recurrence for at least 3 years. (Those who have successfully undergone radical resection or have received possible curative treatments for basal cell carcinoma, superficial bladder cancer, squamous-cell carcinoma, cervical intraepithelial neoplasia or other carcinoma in situ are not limited)
• Presence of any autoimmune disease which requires systemic treatment within the past 2 years. Hormone replacement therapy (for example, insulin or physiological replacement of corticosteroid due to adrenal or pituitary disorders… etc.) is allowed and not considered as systemic treatment.
• Have had any transplantation of allogeneic cell, tissue or solid organ.
• History of known human immunodeficiency virus (HIV) infection.
• Hepatitis B surface antigen (HBsAg) is positive or hepatitis B virus (HBV) DNA viral load is ≥ 500 IU/mL.Or Hepatitis C virus (HCV) antibody is positive and hepatitis C virus (HCV) ribonucleic acid (RNA) is also positive.
• Subject has non-infectious pneumonia history which requires systemic steroids. Subject who currently have interstitial pneumonia or interstitial pneumonitis can join this study if investigator confirms subject's clinical condition is stable.
• Presence of any severe cardiac dysfunction, Class III-IV of chronic heart failure based on New York Heart Association (NYHA) Functional Classification, which includes symptomatic coronary artery disease and severe ventricular arrhythmia; Presence of any myocardial infarction, unstable or poorly controlled angina within 6 months before subject screening visit (V0).
• Have any gastrointestinal history or surgery which investigator believes may affect the absorption of the oral investigational product.
• Enterocutaneous or non- enterocutaneous fistula which is defined as Grade 3 or above based on Common Terminology Criteria for Adverse Events (CTCAE, also known as Common Toxicity Criteria).
• Currently presence of inflammatory bowel disease or gastric ulcer.
• Have not yet recovered from major surgery or complications before subject screening visit(V0).
• History of active tuberculosis (TB, Mycobacterium tuberculosis).
• Presence of any mental disease or drug abuse disorder which may interfere with subject's ability for being compliant with study requirements.
• Active infection which requires systemic treatment.

Sponsors & Collaborators

• Microbio Co Ltd: lead

Study Sites (7)

Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung City, 807, Taiwan

Location

E-Da Hospital

Kaohsiung City, 824, Taiwan

Location

Kaohsiung Chang Gung Memorial Hospital

Kaohsiung City, 833, Taiwan

Location

Taipei Medical University Hospital

Taipei, 110, Taiwan

Location

Taipei Municipal Wanfang Hospital

Taipei, 116, Taiwan

Location

Ministry of Health and Welfare Shuang-Ho Hospital

Taipei, 235, Taiwan

Location

Chang Gung Memorial Hospital Linkou Branch

Taoyuan District, 333, Taiwan

Location

MeSH Terms

Conditions

Neoplasm Metastasis

Condition Hierarchy (Ancestors)

Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 26, 2021
• First Posted: June 1, 2021
• Study Start: August 20, 2021
• Primary Completion: October 23, 2024
• Study Completion: November 30, 2024
• Last Updated: December 18, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

TW (7)