Non-small Cell Lung CancerPhase 2NCT06403111
FMT+Immunotherapy+Chemotherapy As First-line Treatment for Driver-gene Negative Advanced NSCLC
A Phase 2 study testing Fecal Microbiota Transplantation (FMT)+chemotherapy+immunotherapy in people with Non-small Cell Lung Cancer, run by Changzhou No.2 People's Hospital at 1 site in China.
Trial summary
This study plans to reconstruct intestinal microecology through fecal microbiota transplantation (FMT), and combine with standard first-line therapy to enhance the anti-tumor immune effect at the same time, thereby extending the progression-free survival of patients and improving the prognosis of patients. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Non-small Cell Lung Cancer
- What is being tested?
- Fecal Microbiota Transplantation (FMT)+chemotherapy+immunotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2024to 1 Jun 2026
- Phase
- Phase 2
- 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 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- The subjects voluntarily joined the study and were able to sign the informed consent with good compliance;
- Age 18-80 years old (when signing the informed consent form);
- Patients with histologically or cytologically proven locally advanced (stage IIIB/IIIC), metastatic, or recurrent (stage IV) NSCLC who are inoperable and unable to receive radical concurrent chemoradiotherapy, according to the International Association for the Study of Lung Cancer and the American Joint Committee on Cancer Classification, 8th Edition TNM Classification of Lung cancer;
- Have not received systemic intravenous anti-tumor therapy before, and the driver gene is negative;
- PD-L1 expression < 50%;
- According to the solid tumor efficacy evaluation criteria (RECIST version 1.1), there is at least one radiographically measurable lesion; That is, in CT or MRI detection, the longest diameter of a single lesion was ≥10mm, or the pathological enlargement of a single lymph node was ≥15mm.
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- The physical status score of Eastern Tumor Collaboration Group (ECOG) was 0-1;
- Expected survival > 3 months;
- Have adequate organ and bone marrow function, laboratory examination within 7 days prior to enrollment meets the following requirements (no blood components, cell growth factors, albumin or other corrective drugs are allowed within 14 days prior to obtaining laboratory examination), as follows: 1) Blood routine: absolute neutrophil count (ANC) ≥1.5×10 9/L, platelet (PLT) ≥75×10 9/L, hemoglobin (HGB) ≥90 g/L (no blood transfusion or erythropoietin dependence within 14 days); 2) Liver function: serum total bilirubin (TBIL) ≤2 times the upper limit of normal (ULN); Alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) ≤ 5x ULN, serum albumin ≥28 g/L; alkaline phosphatase (ALP) ≤5×ULN; 3) Renal function: serum creatinine (Cr) ≤1.5×ULN, or creatinine clearance ≥50 mL/min (using the standard Cockcroft-Gault formula) : Urine routine results showed urinary protein < 2+; For patients with urine protein ≥2+ at baseline, 24-hour urine collection and 24-hour urine protein quantification < 1g should be performed. 4) Coagulation function: International standardized ratio (INR) or prothrombin time (PT) ≤1.5 times ULN; If the subject is receiving anticoagulant therapy, as long as the INR is within the intended range of anticoagulant drug use.
- For female subjects of reproductive age, a urine or serum pregnancy test should be performed and the result is negative 3 days prior to receiving the initial study drug administration;
- Subjects and their sexual partners are required to use a medically approved contraceptive method (such as an intrauterine device (IUD), contraceptive pill, or condom) during the study treatment period and for 6 months after the end of the study treatment period.
Who cannot join
- Currently participating in an interventional clinical study or receiving another investigational drug or investigational device within 4 weeks prior to initial dosing;
- Received proprietary Chinese medicines with anti-tumor indications or immunomodulatory drugs (thymosin, interferon, interleukin, etc.) within 2 weeks before the first administration, or received major surgical treatment within 3 weeks before the first administration;
- Class III - IV congestive heart failure (New York Heart Association classification), poorly controlled and clinically significant arrhythmias;
- Any arterial thrombosis, embolism or ischemia, such as myocardial infarction, unstable angina pectoris, cerebrovascular accident or transient ischemic attack, occurred within 6 months before treatment;
- Known allergic reaction to the drug in this study;
- Patients who require long-term oral, intravenous, or intramuscular administration of systemic corticosteroids;
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- Symptomatic central nervous metastases. Patients with asymptomatic brain metastases (BMS) or BMS whose symptoms are stable after treatment are eligible to participate in this study if they meet all of the following criteria: measurable lesions outside the central nervous system; No midbrain, pontine, cerebellum, meninges, medulla oblongata or spinal cord metastasis; Maintain clinical stability for at least 2 weeks; Stop hormone therapy 3 days before the first dose of the study drug;
- There is an active infection requiring treatment or systemic anti-infective drugs have been used in the week prior to the first dosing;
- Has not fully recovered from toxicity and/or complications caused by any intervention before starting treatment (i.e., ≤ grade 1 or baseline, excluding weakness or hair loss);
- Known history of human immunodeficiency virus (HIV) infection (i.e. HIV 1/2 antibody positive);
- Untreated active hepatitis B (defined as HBsAg positive and HBV-DNA copy number detected greater than the upper limit of normal value in the laboratory of the study center);
- Active HCV-infected subjects (HCV antibody positive and HCV-RNA levels above the lower limit of detection);
- Received live vaccine within 30 days prior to the first dose (cycle 1, day 1); Note: Injectable inactivated virus vaccine against seasonal influenza is permitted for 30 days prior to initial administration; However, live attenuated influenza vaccines administered intranasally are not permitted.
- Pregnant or lactating women;
- Medical history or evidence of disease that may interfere with test results, prevent participants from fully participating in the study, abnormal treatment or laboratory test values, or other conditions that the investigator considers unsuitable for enrollment The Investigator considers other potential risks unsuitable for participation in the study.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Changzhou No.2 Poeple's Hospital
Changzhou
Hua Jiang
About this study
Official title: Fecal Microbiota Transplantation Combined with Platinum-based Doublet Chemotherapy and Tislelizumab As First-line Treatment for Driver-gene Negative Advanced Non-small-cell Lung Cancer (NSCLC): Study Protocol for a Prospective, Multi-center, Single-arm Exploratory Trial
This study plans to reconstruct intestinal microecology through fecal microbiota transplantation (FMT), and combine with standard first-line therapy to enhance the anti-tumor immune effect at the same time, thereby extending the progression-free survival of patients and improving the prognosis of patients.
Read the detailed description
This is a prospective, single-arm, multi-center, exploratory clinical study. That is, eligible patients with driver-gene negative, ECOG PS 0-1, PD-L1<50% advanced non-small cell lung cancer who have not received prior treatment will be screened after signing informed consent and receive FMT combined with tislelizumab + pemetrexed + platinum-based treatment (lung adenocarcinoma) / albumin-bound paclitaxel + platinum-based treatment (lung squamous cell carcinoma) for 4-6 cycles. If there is no progression of the disease after 4-6 cycles of the first-line treatment, then patients will enter the maintenance treatment stage. Patients will receive tislelizumab maintenance treatment (lung squamous cell carcinoma), or tislelizumab + pemetrexed maintenance treatment (lung adenocarcinoma). RECIST v1.1 was used for tumor evaluation every 6 weeks during treatment. NCI-CTCAE 5.0 was used for safety assessment every 3 weeks. Adverse events were recorded throughout the study to 30 days after the end of treatment. Treatment continues until disease progression, subject withdraws informed consent, loss of follow-up, or death. Patients should provide 10ml whole blood samples and fecal samples at baseline, after two cycles of treatment, before maintenance treatment, and after two cycles of maintenance treatment for the detection of efficacy prediction markers (each cycle is 21 days).
- Conditions
- Non-small Cell Lung Cancer
- Being tested
- Fecal Microbiota Transplantation (FMT)+chemotherapy+immunotherapy
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fecal Microbiota Transplantation (FMT)+chemotherapy+immunotherapyCombination product
Participants will receive FMT combined with tislelizumab + pemetrexed + platinum-based treatment (lung adenocarcinoma) / albumin-bound paclitaxel + platinum-based treatment (lung squamous cell carcinoma) for 4-6 cycles. If there is no progression of the disease after 4-6 cycles of the first-line treatment, then patients will enter the maintenance treatment stage. Patients will receive tislelizumab maintenance treatment (lung squamous cell carcinoma), or tislelizumab + pemetrexed maintenance treatment (lung adenocarcinoma).
| Study group | Role | What they receive |
|---|---|---|
| Chemotherapy+Immunotherapy+FMT | Experimental | Not described Receives: Combination Product: Fecal Microbiota Transplantation (FMT)+chemotherapy+immunotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
12-Months Progression-Free Survival Rate (12month-PFS)
The proportion of patients whose disease did not progress 12 months after treatment
Measured: up to 12 months
Secondary outcomes (6)
Objective Response Rate (ORR)
Objective response rate will be assessed by investigators.
Measured: up to 12 months
Median Progression-Free Survival (mPFS)
Observation for mPFS will be recorded until the end of follow-up after the start of 1st cycle of treatment.
Measured: up to 12 months
Incidence of Adverse events (AEs)
Therapy-related adverse events will be recorded and assessed according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, Version 5.0).
Measured: up to 12 months
Duration of Response (DOR)
The time between the first assessment of a tumor as CR or PR and the first assessment as progressive disease (PD) or death from any cause.
Measured: up to 12 months
The Diversity of Fecal Microbiota
This will be detected by 16s rRNA sequencing or metagenomes.
Measured: up to 12 months
Quality of Life (QoL)
QoL will be evaluated by EORTC-QLQ-C30.
Measured: up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2024
- Study start1 Jun 2024
- Primary completion1 Jun 2026 (estimated)
- Study completion1 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Non-small Cell Lung CancerStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 62 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Changzhou No.2 People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hua Jiang, Changzhou No.2 People's Hospital
- Investigators
- Hua Jiang, MD, Study director, Changzhou No.2 People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06403111
- Sponsor's protocol ID
- [2024]YLJSA005
- Status last verified
- Aug 2024
- First submitted
- 27 Apr 2024
- Last updated
- 20 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wei Y, Qin L, Wu X, Li D, Qian D, Jiang H, Geng Q. Faecal microbiota transplantation combined with platinum-based doublet chemotherapy and tislelizumab as first-line treatment for driver-gene negative advanced non-small cell lung cancer (NSCLC): study protocol for a prospective, multicentre, single-arm exploratory trial. BMJ Open. 2025 Mar 4;15(3):e094366. doi: 10.1136/bmjopen-2024-094366.
PubMed 40037667
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fecal Microbiota Transplantation Combined with Platinum-based Doublet Chemotherapy and Tislelizumab As First-line Treatment for Driver-gene Negative Advanced Non-small-cell Lung Cancer (NSCLC): Study Protocol for a Prospective, Multi-center, Single-arm Exploratory Trial
- ClinicalTrials.gov ID
- NCT06403111
- Acronym / sponsor ID
- [2024]YLJSA005
- Conditions
- Non-small Cell Lung Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 62 participants (estimated)
- Lead sponsor
- Changzhou No.2 People's HospitalUniversity, hospital or other
- Study start
- 1 Jun 2024 (actual)
- Primary completion
- 1 Jun 2026 (estimated)
- Study completion
- 1 Jun 2026 (estimated)
- First posted
- 7 May 2024 (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.
This study plans to reconstruct intestinal microecology through fecal microbiota transplantation (FMT), and combine with standard first-line therapy to enhance the anti-tumor immune effect at the same time, thereby extending the progression-free survival of patients and improving the prognosis of patients.
Detailed description
This is a prospective, single-arm, multi-center, exploratory clinical study. That is, eligible patients with driver-gene negative, ECOG PS 0-1, PD-L1<50% advanced non-small cell lung cancer who have not received prior treatment will be screened after signing informed consent and receive FMT combined with tislelizumab + pemetrexed + platinum-based treatment (lung adenocarcinoma) / albumin-bound paclitaxel + platinum-based treatment (lung squamous cell carcinoma) for 4-6 cycles. If there is no progression of the disease after 4-6 cycles of the first-line treatment, then patients will enter the maintenance treatment stage. Patients will receive tislelizumab maintenance treatment (lung squamous cell carcinoma), or tislelizumab + pemetrexed maintenance treatment (lung adenocarcinoma). RECIST v1.1 was used for tumor evaluation every 6 weeks during treatment. NCI-CTCAE 5.0 was used for safety assessment every 3 weeks. Adverse events were recorded throughout the study to 30 days after the end of treatment. Treatment continues until disease progression, subject withdraws informed consent, loss of follow-up, or death. Patients should provide 10ml whole blood samples and fecal samples at baseline, after two cycles of treatment, before maintenance treatment, and after two cycles of maintenance treatment for the detection of efficacy prediction markers (each cycle is 21 days).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Chemotherapy+Immunotherapy+FMT | Experimental | Combination Product: Fecal Microbiota Transplantation (FMT)+chemotherapy+immunotherapy |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- The subjects voluntarily joined the study and were able to sign the informed consent with good compliance;
- Age 18-80 years old (when signing the informed consent form);
- Patients with histologically or cytologically proven locally advanced (stage IIIB/IIIC), metastatic, or recurrent (stage IV) NSCLC who are inoperable and unable to receive radical concurrent chemoradiotherapy, according to the International Association for the Study of Lung Cancer and the American Joint Committee on Cancer Classification, 8th Edition TNM Classification of Lung cancer;
- Have not received systemic intravenous anti-tumor therapy before, and the driver gene is negative;
- PD-L1 expression < 50%;
Key exclusion criteria (15 listed)
- Currently participating in an interventional clinical study or receiving another investigational drug or investigational device within 4 weeks prior to initial dosing;
- Received proprietary Chinese medicines with anti-tumor indications or immunomodulatory drugs (thymosin, interferon, interleukin, etc.) within 2 weeks before the first administration, or received major surgical treatment within 3 weeks before the first administration;
- Class III - IV congestive heart failure (New York Heart Association classification), poorly controlled and clinically significant arrhythmias;
- Any arterial thrombosis, embolism or ischemia, such as myocardial infarction, unstable angina pectoris, cerebrovascular accident or transient ischemic attack, occurred within 6 months before treatment;
- Known allergic reaction to the drug in this study;
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 |
|---|---|---|
| Fecal Microbiota Transplantation (FMT)+chemotherapy+immunotherapyParticipants will receive FMT combined with tislelizumab + pemetrexed + platinum-based treatment (lung adenocarcinoma) / albumin-bound paclitaxel + platinum-based treatment (lung squamous cell carcinoma) for 4-6 cycles. If there is no progression of the disease after 4-6 cycles of the first-line treatment, then patients will enter the maintenance treatment stage. Patients will receive tislelizumab maintenance treatment (lung squamous cell carcinoma), or tislelizumab + pemetrexed maintenance treatment (lung adenocarcinoma). | Combination product | Chemotherapy+Immunotherapy+FMT |
Primary outcome
12-Months Progression-Free Survival Rate (12month-PFS)
Time frame: up to 12 months
The proportion of patients whose disease did not progress 12 months after treatment
6 secondary outcomes
Objective Response Rate (ORR)
Time frame: up to 12 months
Median Progression-Free Survival (mPFS)
Time frame: up to 12 months
Incidence of Adverse events (AEs)
Time frame: up to 12 months
Duration of Response (DOR)
Time frame: up to 12 months
The Diversity of Fecal Microbiota
Time frame: up to 12 months
Quality of Life (QoL)
Time frame: up to 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2024.
- Derived from this study: PubMed 40037667Wei Y, Qin L, Wu X, Li D, Qian D, Jiang H, Geng Q. Faecal microbiota transplantation combined with platinum-based doublet chemotherapy and tislelizumab as first-line treatment for driver-gene negative advanced non-small cell lung cancer (NSCLC): study protocol for a prospective, multicentre, single-arm exploratory trial. BMJ Open. 2025 Mar 4;15(3):e094366. doi: 10.1136/bmjopen-2024-094366.
- 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.
Hua Jiang, MD study director
Changzhou No.2 People's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Fecal Microbiota Transplantation (FMT)+chemotherapy+immunotherapy in people with Non-small Cell Lung Cancer, run by Changzhou No.2 People's Hospital at 1 site in China.
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 11 inclusion and 15 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: status not confirmed, as of the sponsor's last update on 20 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 1 site in China. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hua Jiang, MD (+86-18015852711, czeyjh@njmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
12-Months Progression-Free Survival Rate (12month-PFS) (time frame: up to 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06403111, which also lists 1 linked publication.
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 20 Dec 2024.