NSCLC Stage IIIB~IVNCT04909034
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
A study testing MS-20 in people with NSCLC Stage IIIB~IV, run by Microbio Co Ltd at 7 sites in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- NSCLC Stage IIIB~IV
- What is being tested?
- MS-20
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 15 participants
- Where
- 7 sitesTaiwan
- Study dates
- 20 Aug 2021to 30 Nov 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
- To collect stool specimens at home, refrigerate and deliver the sample.
Who cannot join
- 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.
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- 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.
- Allergies to soy products, severe allergies to antibody therapy, or known allergies or intolerances to any component of pembrolizumab.
- Have received any biologic therapy within 3 weeks prior to the first dose of trial therapy.
- Have received anti-PD-1, anti-PD-L1, or anti-PD-L2 drug therapy within 3 years before the screening visit (V0) or act on another drug treatment that stimulates signals or synergistically inhibits T cell receptors (e.g. CTLA-4 , OX 40, CD137).
- Received radiotherapy within the 14 days before receiving the investigational drug, or received pulmonary radiotherapy> 30 Gy within 6 months before receiving the investigational drug (the subject must recover from all radiation-related toxicities to grade 1 or below, without corticosteroid therapy and radiation pneumonia has never occurred).
- Diagnosed with immunodeficiency or are receiving any form of immunosuppressive therapy, systemic steroids (allowed to use up to 10 mg Prednisone or equivalent steroids per day) within 7 days before receiving the investigational drug.
- Those who have received live-virus vaccines within 30 days before receiving the investigational drug or are expected to receive live-virus vaccines during the study period.
- Have used antibacterial drugs including antibiotics and synthetic drugs (such as sulfonamides, quinolones), antifungal or antiviral drugs (not including topical medication) within the 14 days before receiving the investigational drug.
- Use probiotics and probiotic-related products within 14 days before receiving this test drug (e.g. yogurt, yogurt, Yakult, probiotic fermented beverages, Wakamoto tablets, Shin Biofermin S tablets, inulin, oligosaccharide products).
- Have used laxatives (such as MgO, Bisacodyl, Sennoside, Lactulose) within the 14 days before receiving the investigational drug.
- Those who have had gastrointestinal infection and diarrhea within the 14 days before receiving the investigational drug (soft or watery stools more than three times within 24 hours).
- Women who are pregnant, breastfeeding or expect to breastfeed during the study period.
- Currently participating in clinical trials of other investigational product treatments, medical devices, health foods, or cosmetics.
- Subjects who judged by the investigator to be unsuitable to participate in the trial.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
Taiwan7 sites
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, 807
E-Da Hospital
Kaohsiung City, 824
Kaohsiung Chang Gung Memorial Hospital
Kaohsiung City, 833
Taipei Medical University Hospital
Taipei, 110
Taipei Municipal Wanfang Hospital
Taipei, 116
Ministry of Health and Welfare Shuang-Ho Hospital
Taipei, 235
Chang Gung Memorial Hospital Linkou Branch
Taoyuan, 333
About this study
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
- Being tested
- MS-20, Placebo
- Keywords
- NSCLC, MS-20, Add-on, pembrolizumab, metastatic, microbiome, microbiota
- Medical subject headings
- Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MS-20Drug
Also called Chemo young
Fermented soybean extract MicrSoy-20(MS-20), which uses a variety of lactic acid bacteria and yeasts to metabolize organic soybeans
PlaceboDrug
Oral solution without active ingredients
| Study group | Role | What they receive |
|---|---|---|
| MS-20 oral solution | Experimental | Oral Solution 4 c.c, divided twice daily (BID) for 48 weeks. Receives: Drug: MS-20 |
| Placebo | Placebo comparator | Oral Solution 4 c.c, divided twice daily (BID) for 48 weeks. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 48 weeks
Secondary outcomes (4)
Progression free survival (PFS)
According to Solid Tumor Efficacy Evaluation Criteria Version 1.1 (RECIST 1.1), is defined as the time from the beginning of the treatment period to the first documented progressive disease (PD) or death from any other non-PD cause (whichever occurs first).
Measured: 48 weeks
Disease control rate (DCR)
According to the Solid Tumor Efficacy Evaluation Criteria Version 1.1 (RECIST 1.1), defined as the proportion of subjects whose optimal overall response was determined to be a complete response (CR), partial response (PR), or disease stabilization (SD).
Measured: 48 weeks
Duration of response (DOR)
Assessed according to the Solid Tumor Efficacy Evaluation Criteria Version 1.1 (RECIST 1.1), defined as the minimum time from the first observation of a complete response (CR) or partial response (PR) to disease progression (PD) or death for subjects whose best overall response after treatment is complete response (CR) or partial response (PR). Otherwise, DOR will be the time of the last tumor evaluation.
Measured: 48 weeks
Safety assessment- incidence of adverse events (TEAEs)
Following treatment with the investigational product. According to "The NCI Common Terminology Criteria for Adverse Events Fifth Edition Evaluation Form; Common Terminology Criteria for Adverse Events (CTCAE) V5.0" as a clinical evaluation tool.
Measured: 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2021
- Study start20 Aug 2021
- Primary completion23 Oct 2024
- Study completion30 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NSCLC Stage IIIB~IVStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Microbio Co Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04909034
- Sponsor's protocol ID
- MB103CLAS08
- Status last verified
- Dec 2024
- First submitted
- 26 May 2021
- Last updated
- 18 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04909034
- Acronym / sponsor ID
- MB103CLAS08
- Conditions
- NSCLC Stage IIIB~IV
- Keywords
- NSCLC, MS-20, Add-on, pembrolizumab, metastatic, microbiome, microbiota
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Microbio Co LtdIndustry (pharma, biotech, devices)
- Study start
- 20 Aug 2021 (actual)
- Primary completion
- 23 Oct 2024 (actual)
- Study completion
- 30 Nov 2024 (actual)
- First posted
- 1 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MS-20 oral solution | Experimental | Drug: MS-20Oral Solution 4 c.c, divided twice daily (BID) for 48 weeks. |
| Placebo | Placebo comparator | Drug: PlaceboOral Solution 4 c.c, divided twice daily (BID) for 48 weeks. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- 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.
Key exclusion criteria (28 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MS-20Also: Chemo youngFermented soybean extract MicrSoy-20(MS-20), which uses a variety of lactic acid bacteria and yeasts to metabolize organic soybeans | Drug | MS-20 oral solution |
| PlaceboOral solution without active ingredients | Drug | Placebo |
Primary outcome
To evaluate the objective response rate (ORR) in subjects with metastatic non-small cell lung cancer (NSCLC) treated with MS-20 combined with pembrolizumab.
Time frame: 48 weeks
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).
4 secondary outcomes
Progression free survival (PFS)
Time frame: 48 weeks
Disease control rate (DCR)
Time frame: 48 weeks
Duration of response (DOR)
Time frame: 48 weeks
Safety assessment- incidence of adverse events (TEAEs)
Time frame: 48 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MS-20 in people with NSCLC Stage IIIB~IV, run by Microbio Co Ltd at 7 sites in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the objective response rate (ORR) in subjects with metastatic non-small cell lung cancer (NSCLC) treated with MS-20 combined with pembrolizumab. (time frame: 48 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2024.