Non-Small Cell Lung Cancer (NSCLC)
Conditions
Interventions
Single-Arm Study (No Control Group):FMT+ICIs+Pemetrexed/Gemcitabine
Sponsors
The First Affiliated Hospital of Soochow University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Voluntary Participation: Fully understands the trial and has voluntarily signed the informed consent form (ICF); able to comply with protocol-specified visits and procedures. 2. Age & Gender: Age >=18 years at enrollment, any gender. 3. Performance Status: Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1. 4. Life Expectancy: Expected survival >=3 months. 5. Diagnosis: Histologically and/or cytologically confirmed driver gene-negative non-small cell lung cancer (NSCLC) (adenocarcinoma or squamous cell carcinoma). 6.Prior Therapy: Disease progression after first-line immune checkpoint inhibitor (ICI) treatment. 7. Measurable Lesion: At least one measurable tumor lesion per RECIST v1.1 criteria. 8. Tissue Sample Provision: Willing and able to provide formalin-fixed paraffin-embedded (FFPE) tumor tissue blocks or sections: Archived (within 2 years before ICF signing) or freshly obtained samples for PD-L1 expression testing and exploratory biomarker analyses. 9. Adequate Organ/Bone Marrow Function: Hematology: Absolute neutrophil count (ANC) >=1.5 × 10^9/L Platelet count (PLT) >=100 × 10^9/L Hemoglobin (HGB) >=9 g/dL Liver Function: Total bilirubin (TBIL) ==60 mL/min (calculated by Cockcroft-Gault formula) Coagulation: International normalized ratio (INR), prothrombin time (PT), and partial thromboplastin time (PTT) =<1.5 × ULN (unless on anticoagulant therapy); 10. Contraception: Childbearing potential participants (or partners of childbearing potential) must use highly effective contraception during treatment and for 6 months after treatment completion.
Exclusion criteria
Exclusion criteria: 1. Oncogenic Driver Mutations: Presence of EGFR or ALK gene alterations. 2. Concurrent Malignancy: Any active malignancy =10 mg/day prednisone equivalent) or other immunosuppressants within 2 weeks prior to first dose. 8. Transplant History: History of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation. 9. Pulmonary Inflammation: History of (non-infectious) pneumonitis requiring steroids or current pneumonitis. 10. Active Tuberculosis: Known active tuberculosis (TB). 11. Uncontrolled Infections: Uncontrolled active fungal, bacterial, viral, or other infections. 12. Viral Infections: Active hepatitis B (HBV-DNA >=2,000 IU/mL) HCV infection HIV-positive Active syphilis Exception: HBV-DNA =4 weeks on repeat imaging) Clinically stable with no intracranial/spinal hemorrhage history No steroids =14 days before first dose No stereotactic radiotherapy =7 days, whole-brain radiotherapy =14 days, or neurosurgery =28 days Metastases confined to cerebellum/supratentorial regions (no midbrain/pons/medulla/spinal cord involvement) Measurable extracranial lesion(s) present; 14. Uncontrolled Effusions: Uncontrolled ascites, pleural, or pericardial effusions (requiring drainage =monthly). Permitted if clinically stable after therapeutic thoracentesis/paracentesis. 15. Acute Conditions: Clinically active hemoptysis, diverticulitis, intra-abdominal abscess, or gastrointestinal obstruction. 16. Bleeding Disorders: Significant clinically relevant bleeding (e.g., GI bleeding, hemorrhagic gastric ulcer) within 1 month prior to first dose OR active bleeding on endoscopy. 17. Cardiovascular Disease: Any of the following within 6 months prior to enrollment: Acute myocardial infarction Symptomatic pulmonary embolism Symptomatic congestive heart failure (NYHA class III/IV) =Grade 2 ventricular arrhythmia Cerebrovascular accident (CVA) or transient ischemic attack (TIA); 18. Residual Toxicities: Prior anti-tumor
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ORR; | — |
Secondary
| Measure | Time frame |
|---|---|
| DCR/DOR;PFS/OS;Incidence of Adverse Events (Frequency/Percentage); | — |
Countries
China
Contacts
Public ContactChen Kai
The First Affiliated Hospital of Soochow University
Outcome results
None listed