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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 (Jun 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 Jun 2026Location: China

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

Treatments studied

Other

Fecal Microbiota Transplantation (FMT)+chemotherapy+immunotherapy

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)

Demographics

Ages ≤ 80

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.

Frequently asked questions

Is NCT06403111 currently recruiting?

Yes, this trial is currently recruiting patients.

Can patients have received prior systemic therapy?

No. This trial requires treatment-naive patients — prior systemic therapy is an exclusion criterion.

Does this trial require EGFR?

Yes, EGFR wild-type is a required biomarker for enrollment.

Does this trial require ALK?

Yes, ALK wild-type is a required biomarker for enrollment.

Does this trial require ROS1?

Yes, ROS1 wild-type is a required biomarker for enrollment.

What disease stage is eligible?

Stage IIIB or IIIC or IV is required.

Is there an age limit?

Yes. Patients must be 80 years or younger.

Could you qualify for this trial?

Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.

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