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

Status: Recruiting
Location: See location...
Intervention Type: Combination product
Study Type: Interventional
Study Phase: Phase 2
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: t
View:

• 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.

• 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.

Locations
Other Locations
China
Changzhou No.2 Poeple's Hospital
RECRUITING
Changzhou
Contact Information
Primary
Hua Jiang, MD
czeyjh@njmu.edu.cn
+86-18015852711
Time Frame
Start Date: 2024-06-01
Estimated Completion Date: 2026-06-01
Participants
Target number of participants: 62
Treatments
Experimental: Chemotherapy+Immunotherapy+FMT
Sponsors
Leads: Changzhou No.2 People's Hospital

This content was sourced from clinicaltrials.gov