Non-small cell lung cancer
Conditions
Interventions
Experimental group:Neoadjuvant Chemotherapy Combined with Probiotic LR607 During Treatment
Sponsors
Zhujiang Hospital of Southern Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Meets the diagnostic criteria, aged 18-80 years, voluntarily participates in this study, is able to sign the informed consent form, and has good compliance; 2. Assessed according to the 8th edition of the American Joint Committee on Cancer staging system, pathologically confirmed as stage II-IIIB (involving >=1 ipsilateral mediastinal lymph node or subcarinal lymph node [N2 lymph node stage]) NSCLC, considered resectable based on a surgical consultation and investigator assessment; Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1; 3. Has not previously received systemic treatment for NSCLC, negative for driver mutations; 4. Karnofsky performance status >=70%; 5. Baseline organ and bone marrow function must be adequate, meeting all of the following laboratory criteria within 14 days prior to the first dose: (1) Absolute neutrophil count (ANC) without granulocyte colony-stimulating factor support >= 1500/µL; (2) White blood cell count >= 2500/µL; (3) Platelet count without transfusion >= 100,000/µL; (4) Hemoglobin >= 9 g/dL (>= 90 g/L); (5) Alanine aminotransferase (ALT), aspartate aminotransferase (AST), and alkaline phosphatase (ALP) = 2.8 g/dL; (8) Prothrombin time (PT)/International Normalized Ratio (INR) or activated partial thromboplastin time (APTT) = 40 mL/min (>= 0.675 mL/sec) using the Cockcroft-Gault equation: Male: (140 - age) × weight (kg) / (serum creatinine [mg/dL] × 72) Female: [(140 - age) × weight (kg) / (serum creatinine [mg/dL] × 72)] × 0.85 (10) Urine protein-to-creatinine ratio (UPCR) <= 1 mg/mg (<= 113.2 mg/mmol), or 24-hour urine protein <= 1 g; 6. Able to understand and comply with the protocol requirements and must sign the informed consent form; 7. For female subjects of childbearing potential, a urine or serum pregnancy test should be conducted within 3 days prior to the initial administration of the study drug, and the result must be negative; 8. Subjects and their sexual partners must use medically approved contraception methods (such as an intrauterine device, contraceptive pills, or condoms) during the study treatment and for 6 months after the end of the study treatment.
Exclusion criteria
Exclusion criteria: 1. Previous use of targeted therapy; 2. Currently using or planning to use probiotics, yogurt, or bacteria-fortified foods during treatment; 3. Active interstitial lung disease (ILD)/pneumonia or a history of ILD/pneumonia requiring systemic steroid treatment; 4. Known medical conditions (e.g., conditions related to diarrhea or acute diverticulitis) that the investigator believes would increase the risks associated with study participation or the management of the study drug, or interfere with the interpretation of safety outcomes; 5. Receipt of any type of small molecule kinase inhibitor (including investigational kinase inhibitors) within 2 weeks prior to the first dose of study treatment; 6. Receipt of any type of cytotoxic, biologic, or other systemic anticancer therapy (including investigational therapy) within 4 weeks prior to the first study treatment; 7. Receipt of bone metastasis radiotherapy within 2 weeks or any other radiotherapy within 4 weeks prior to the first study treatment. Receipt of systemic therapy with radiopharmaceuticals within 6 weeks prior to the first study treatment. Subjects with clinically relevant ongoing complications from prior radiotherapy; 8. Known brain metastases or cranial epidural disease, unless fully treated with radiotherapy and/or surgery (including stereotactic surgery), and stable for at least 4 weeks before the first dose of study treatment following radiotherapy, or stable for at least 4 weeks before the first dose of study treatment following major surgery (e.g., resection or biopsy of brain metastases). Subjects must have complete wound healing from major or minor surgery before the first dosing. Eligible subjects must be neurologically asymptomatic and not receiving corticosteroid therapy at the time of the first dose; 9. Anticoagulant therapy in combination with coumarin drugs (e.g., warfarin), direct thrombin inhibitors (e.g., dabigatran), direct Factor Xa inhibitors (e.g., betrixaban), or antiplatelet agents (e.g., clopidogrel). The allowed anticoagulants are as follows: (1) Prophylactic low-dose aspirin for cardiac protection (per local applicable guidelines) and low-dose low molecular weight heparin (LMWH); (2) Therapeutic dose LMWH or anticoagulation with direct Factor Xa inhibitors rivaroxaban, edoxaban, or apixaban in subjects without known brain metastases, using a stable dose of the anticoagulant for at least 1 week prior to the first dose, and with no clinically significant bleeding complications in the anticoagulation regimen or tumor; 10. Vaccination with live attenuated vaccines within 30 days prior to the first dose of study treatment; 11. Subjects with uncontrolled, severe, or recent comorbid or acute diseases, including but not limited to the following: (1) Cardiovascular diseases: 1) Congestive heart failure NYHA class 3 or 4, unstable angina, severe arrhythmia; 2) Uncontrolled hypertension defined as sustained blood pressure (BP): systolic >140 mmHg or diastolic >90 mmHg despite optimal antihypertensive therapy; 3) Stroke (including transient ischemic attack [TIA]), myocardial infarction (MI), or other cerebral ischemic events, or thromboembolic events (e.g., deep vein thrombosis, pulmonary embolism) within 6 months prior to the first dose; (2) Gastrointestinal diseases, including conditions associated with a high risk of perforation or fistula formation: 1) Evidence of tumor invading the gastrointestinal tract, active peptic ulcer, inflammatory bowel disease (e.g., Cr
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Major Pathological Response; | — |
Secondary
| Measure | Time frame |
|---|---|
| Pathological Complete Response, pCR;Event free survival, EFS;LR607 Planting Situation;Ability of gut microbiota to activate NOD2;Treatment-related adverse events, TRADs; | — |
Countries
China
Contacts
Public ContactXiaolong He
Zhujiang Hospital of Southern Medical University
Outcome results
None listed