Primary non-small cell lung cancer diagnosed by cytology or histology (including non-squamous and squamous carcinomas)
Conditions
Interventions
FMD group:FMD+Tislelizumab+PP/TP/PC/TC
Sponsors
Army Medical Center of PLA
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Sign the written informed consent form (Informed Consent Form, ICF), and be able to comply with the visit and related procedures stipulated in the protocol. 2. Age: 18 - 75 years old. 3. BMI >= 18.5 (for patients over 70 years old, BMI requirement is >= 20). 4. Histologically or cytologically confirmed primary non-small cell lung cancer (including non-squamous and squamous types). 5. According to the International Association for the Study of Lung Cancer and the 8th edition of the American Joint Committee on Cancer (AJCC8) lung cancer TNM staging classification, the clinical stage is II, IIIA or IIIB (limited to resectable N2). Resectable N2 refers to non-large masses (defined as short diameter less than 3 cm), discrete or single-site N2 involvement. If clinically suspected as N2 or N3, and pathologically confirmed to be clinically feasible, then pathologic confirmation is preferred. 6. For non-squamous NSCLC study participants, genetic testing must clearly show negative for EGFR and ALK driver genes; for squamous NSCLC study participants, genetic testing is not mandatory, but study participants with known positive EGFR and ALK driver genes should not be enrolled. 7. Considered suitable for radical resection. 8. According to the surgeon's assessment, the total lung function can withstand the planned lung resection surgery, and there are no surgical contraindications. 9. According to RECIST V1.1, there is at least one measurable lesion. 10. Eastern Cooperative Oncology Group Performance Status (ECOG PS) score in the United States is 0 or 1. 11. Has not received any systemic anti-tumor treatment or local treatment (including but not limited to radiotherapy) for NSCLC in the past. 12. Has adequate organ and bone marrow functions. The laboratory test values within 7 days before enrollment must meet the following requirements (no blood components, cell growth factors, albumin, and other drugs for correcting hematological or liver and kidney dysfunction should be given within 14 days before laboratory tests): - Hematological function is adequate, defined as absolute neutrophil count >= 1.5 × 10^9 /L, platelet count >= 100 × 10^9 /L, and hemoglobin >= 100 g/L; - Liver function is adequate, defined as total bilirubin level = 35 g/L; - Renal function is adequate, serum creatinine (Scr) = 60 mL/min (calculated using the Cockcroft/Gault formula) and urine routine test shows urine protein (UPRO) < 2+ or 24-hour urine protein quantification < 1 g. ? During the 7 days prior to the treatment, the international normalized ratio (INR) was <= 1.5 × ULN, and the prothrombin time (PT) or activated partial thromboplastin time (APTT) was <= 1.5 × ULN. 13. For female participants of childbearing age, the urine or serum pregnancy test was negative within 7 days before the administration of the first study drug. If the urine pregnancy test result was positive, a blood pregnancy test was required. 14. If there is a risk of conception, both male and female patients need to use highly effective contraception (i.e., a method with an annual failure rate of less than 1%) and continue it for at least 180 days after the cessation of the trial treatment. Note: If abstinence is the participant's usual lifestyle and preferred method of contraception, abstinence c
Exclusion criteria
Exclusion criteria: 1. Poor nutritional status, presence of tumor cachexia, and a nutritional risk score (NRS2002) >= 3 points. 2. Difficult to adhere to the FMD diet plan for eating. 3. Pathological examination shows the presence of small cell carcinoma, neuroendocrine carcinoma, sarcoma, salivary gland tumor, and mesenchymal tumor components. 4. Tumor invades the diaphragm, mediastinum, heart, pericardium, major blood vessels (such as the aorta), trachea, recurrent laryngeal nerve, esophagus, vertebrae, and carina. 5. Upper lobe pulmonary mass. 6. The contralateral lung lobe has malignant tumor nodules; if the clinical suspicion is that there are tumor nodules in the contralateral lung lobe, a biopsy should be performed to clarify. 7. Patients confirmed or suspected of having brain metastasis. 8. Currently participating in interventional clinical research treatment, or having received other research drugs or research devices within 4 weeks before randomization. 9. Previously used any drugs or devices acting on the T-cell co-stimulation or immune checkpoint pathways (such as OX40, CD137, etc.) and adoptive cell immunotherapy that target PD-1, PD-L1, programmed death ligand 2 (PD-L2), or cytotoxic T lymphocyte-associated antigen 4 (CTLA-4), or any other drugs (such as thymosin, interferon, interleukin) with immunomodulatory effects within 2 weeks before randomization. 10. Within 2 weeks before randomization, received traditional Chinese medicine or Chinese patent medicine with anti-tumor indications, or drugs with immunomodulatory effects (including thymosin, interferon, interleukin). 11. Within 4 weeks before randomization, underwent major surgery. 12. Have unhealed surgical incisions, ulcers, or fractures. 13. Within 4 weeks before randomization, received attenuated live vaccines (or planned to receive attenuated live vaccines during the study period). Note: Injection of inactivated virus vaccine for seasonal influenza is allowed; 2.however, attenuated live influenza vaccine is not allowed. 14. Patients requiring long-term systemic use of corticosteroids; within 7 days before randomization, are receiving any other form of immunosuppressive therapy. Note: Nasal, inhalation, or other local glucocorticoids or physiological doses of systemic glucocorticoids (<= 10 mg/day of prednisone or equivalent drugs) or used for pretreatment (such as preventing contrast agent allergy) are allowed. 15. Within 1 year before randomization, had a history of non-infectious pneumonia requiring corticosteroid treatment or currently has interstitial lung disease. 16. Within 2 years before randomization, had an active autoimmune disease requiring systemic treatment (such as using disease-modifying drugs, corticosteroids, or immunosuppressants), including but not limited to inflammatory bowel disease, such as ulcerative colitis or Crohn's disease; diverticulitis; celiac disease; systemic lupus erythematosus; sarcoidosis syndrome or Wegener's syndrome (granulomatous polyangiitis); Graves' disease; rheumatoid arthritis; multiple sclerosis; vasculitis; glomerulonephritis; .antiphospholipid syndrome; pituitary inflammation; uveitis, etc. Alternative therapies (such as thyroid hormone, insulin, or physiological doses of corticosteroids for adrenal or pituitary insufficiency) are not considered systemic treatment. Patients with positive autoimmune antibodies need to be evaluated and confirmed by the investigator that there is no need for systemic treatment of autoimmune d
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main pathological remission, MPR; | — |
Secondary
| Measure | Time frame |
|---|---|
| disease control rate, DCR;pCR;objective response rate, ORR; | — |
Countries
China
Contacts
Public ContactMengxia Li
Army Medical Center of PLA
Outcome results
None listed