Fecal Microbiota Transplantation with Chemotherapy and Tislelizumab as First Treatment for Advanced Non-small Cell Lung Cancer without Driver Gene Mutations
Led by Changzhou No.2 People's Hospital · Updated on 2024-12-20
62
Participants Needed
1
Research Sites
104 weeks
Total Duration
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AI-Summary
Official Title
Who Can Participate
AI-Screening
Trial Site Locations
Research Team
How is the study designed?
Frequently Asked Questions
AI-Summary
What this Trial Is About
Researchers are studying patients with advanced non-small cell lung cancer (NSCLC) who do not have specific driver gene mutations and have low PD-L1 expression. This Phase 2 trial aims to explore whether combining fecal microbiota transplantation (FMT) with standard first-line treatments can improve the immune response against tumors and extend the time patients live without their cancer worsening. The study involves participants who have not yet received any prior systemic treatment and have a good performance status.
Participants will receive FMT together with tislelizumab plus chemotherapy for 4 to 6 cycles. The chemotherapy regimen differs by cancer type: lung adenocarcinoma patients receive pemetrexed plus platinum-based chemotherapy, while lung squamous cell carcinoma patients receive albumin-bound paclitaxel plus platinum-based chemotherapy. After these initial cycles, if the disease has not progressed, patients will continue with maintenance therapy using tislelizumab alone or combined with pemetrexed, depending on their cancer subtype.
During the study, tumor responses will be evaluated every 6 weeks using imaging criteria, and safety will be assessed every 3 weeks. Blood and stool samples will be collected at multiple time points to study markers that may predict treatment effectiveness. Treatment continues until the cancer progresses, the patient withdraws, or other study endpoints occur. Adverse events will be monitored throughout the study and for 30 days after treatment ends. The main outcome measured is the rate of patients living without cancer progression for 12 months.
CONDITIONS
Official Title
FMT+Immunotherapy+Chemotherapy As First-line Treatment for Driver-gene Negative Advanced NSCLC
Who Can Participate
Age: 18Years - 80Years
All Genders
Healthy Volunteers
Eligibility Criteria
You may qualify if you...
Subjects must voluntarily join the study and be able to sign informed consent with good compliance
Age between 18 and 80 years at consent
Histologically or cytologically confirmed locally advanced, metastatic, or recurrent NSCLC (stage IIIB/IIIC or IV) that is inoperable and unsuitable for radical concurrent chemoradiotherapy
No prior systemic intravenous anti-tumor therapy and negative for driver gene mutations
PD-L1 expression less than 50%
At least one measurable lesion by CT or MRI (single lesion diameter 6450mm or single lymph node enlargement 6415mm)
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Expected survival greater than 3 months
Adequate organ and bone marrow function based on recent laboratory tests within 7 days before enrollment
Negative pregnancy test for females of reproductive age within 3 days before first treatment
Use of medically approved contraception during treatment and for 6 months after study treatment ends
You will not qualify if you...
Participation in another interventional clinical study or receiving investigational drugs/devices within 4 weeks before starting treatment
Use of anti-tumor proprietary Chinese medicines or immunomodulatory drugs within 2 weeks before treatment, or major surgery within 3 weeks before treatment
Severe heart failure (Class III-IV) or poorly controlled serious arrhythmias
Recent (within 6 months) arterial thrombosis, embolism, or ischemia events
Known allergies to study drugs
Need for long-term systemic corticosteroids
Symptomatic brain metastases; asymptomatic brain metastases allowed only under strict conditions
Active infection requiring treatment or recent use of systemic anti-infective drugs within 1 week before treatment
Incomplete recovery from previous treatment toxicities (grade >1)
Known HIV infection
Active untreated hepatitis B or C infections
Receipt of live vaccines within 30 days before treatment start (except seasonal influenza inactivated vaccine)
Pregnant or breastfeeding women
Any medical condition or abnormal test results that, in investigator's opinion, would interfere with study participation or safety
AI-Screening
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Trial Site Locations
Total: 1 location
1
Changzhou No.2 Poeple's Hospital
Changzhou, China
Actively Recruiting
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Research Team
H
Hua Jiang, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Frequently Asked Questions
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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.
