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New treatment option for Non-small Cell Lung Cancer
Official title FMT+Immunotherapy+Chemotherapy As First-line Treatment for Driver-gene Negative Advanced NSCLC
ClinicalTrials.gov ID: NCT06403111
What this study is testing
What is Fecal Microbiota Transplantation (FMT)+chemotherapy+immunotherapy?
Fecal Microbiota Transplantation (FMT)+chemotherapy+immunotherapy is an investigational medicine, being studied as a potential treatment for non-small cell lung cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80. Healthy volunteers may be eligible.
You may be able to join if
- The people 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...
- Have not received systemic intravenous anti-tumor therapy before, and the driver gene is negative;
- PD-L1 expression \< 50%;
You likely can't join if
- Currently participating in an treatment clinical study or receiving another investigational drug or investigational device within 4 weeks prior to...
- Received proprietary Chinese medicines with anti-tumor indications or immunomodulatory drugs (thymosin, interferon, interleukin, etc.) within 2 weeks...
- 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...
- Known allergic reaction to the drug in this study;
- Patients who require long-term oral, intravenous, or intramuscular administration of systemic corticosteroids;
See the full eligibility criteria
- The people 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...
- Have not received systemic intravenous anti-tumor therapy before, and the driver gene is negative;
- PD-L1 expression \< 50%;
- According to the solid tumor how well it works 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...
- 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...
- For female people 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;
- people 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...
- Currently participating in an treatment 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...
- 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;
- 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...
- 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 people (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...
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Changzhou, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Changzhou, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.