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.
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;
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;
Single group
Fecal Microbiota Transplantation (FMT)+chemotherapy+immunotherapy
Combination productParticipants 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).
12-Months Progression-Free Survival Rate (12month-PFS)
The proportion of patients whose disease did not progress 12 months after treatment
Objective Response Rate (ORR)
Objective response rate will be assessed by investigators.
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.
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).
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.
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