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OncoMatch/Clinical Trials/NCT06403111

FMT+Immunotherapy+Chemotherapy As First-line Treatment for Driver-gene Negative Advanced NSCLC

Is NCT06403111 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Fecal Microbiota Transplantation (FMT)+chemotherapy+immunotherapy for non-small cell lung cancer.

Phase 2RecruitingChangzhou No.2 People's HospitalNCT06403111Data as of May 2026

Treatment: Fecal Microbiota Transplantation (FMT)+chemotherapy+immunotherapyThis 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.

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Extracted eligibility criteria

Cancer type

Non-Small Cell Lung Carcinoma

Biomarker criteria

Required: EGFR wild-type

the driver gene is negative

Required: ALK wild-type

the driver gene is negative

Required: ROS1 wild-type

the driver gene is negative

Required: BRAF wild-type

the driver gene is negative

Required: MET wild-type

the driver gene is negative

Required: RET wild-type

the driver gene is negative

Required: HER2 (ERBB2) wild-type

the driver gene is negative

Required: KRAS wild-type

the driver gene is negative

Required: PD-L1 (CD274) expression < 50% (< 50%)

PD-L1 expression < 50%

Disease stage

Required: Stage IIIB, IIIC, IV

Performance status

ECOG 0–1(Restricted strenuous activity)

Prior therapy

No prior treatment (treatment-naive required)
Max 0 prior lines

Cannot have received: systemic intravenous anti-tumor therapy

Have not received systemic intravenous anti-tumor therapy before

Lab requirements

Blood counts

ANC ≥1.5×10^9/L; PLT ≥75×10^9/L; HGB ≥90 g/L (no blood transfusion or erythropoietin dependence within 14 days)

Kidney function

serum creatinine ≤1.5x ULN or creatinine clearance ≥50 mL/min; urine protein <2+; if ≥2+, 24-hour urine protein <1g

Liver function

serum total bilirubin (TBIL) ≤2x ULN; ALT and/or AST ≤5x ULN; serum albumin ≥28 g/L; ALP ≤5x ULN

adequate organ and bone marrow function, laboratory examination within 7 days prior to enrollment meets the following requirements...

Structured fields extracted by AI. May contain errors — verify against the official protocol.

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