Actively Recruiting
FMT+Immunotherapy+Chemotherapy As First-line Treatment for Driver-gene Negative Advanced NSCLC
Led by Changzhou No.2 People's Hospital · Updated on 2024-12-20
62
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
FMT+Immunotherapy+Chemotherapy As First-line Treatment for Driver-gene Negative Advanced NSCLC
Who Can Participate
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
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Changzhou No.2 Poeple's Hospital
Changzhou, China
Actively Recruiting
Research Team
H
Hua Jiang, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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