Lung cancer
Conditions
Interventions
Iinterventional group:Neoadjuvant immunotherapy combined with chemotherapy for 3 cycles: Neoadjuvant treatment is administered on Day 1, Day 22, and Day 43.
Immunotherapy regimen: Serplulimab 300 mg
Sponsors
Zhejiang cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Age: 18-75 years old; 2. Gender: No gender restrictions; 3. Clinically, it is diagnosed as non-small cell lung cancer through histopathology. If the pathological type is adenocarcinoma, EGFR/ALK/ROS1 positive mutations are excluded; 4. According to AJCC 8th edition, the clinical stage is II-IIIB, which has been evaluated as operable or potentially resectable; 5. ECOG behavioral status score of 0-1, expected survival time > 1 year; 6. The level of organ function must meet the following requirements: (1) Bone marrow: Absolute neutrophil count (ANC) >= 1.5 × 10^9/L, platelets = 100 × 10^9/L, hemoglobin >= 9 g/dl; (2) Good coagulation function: defined as International Normalized Ratio (INR) or Prothrombin Time (PT) = 60 ml/min; 7. Women of childbearing age must undergo a pregnancy test with a negative result within 7 days before starting treatment, and take contraceptive measures during and within 3 months after treatment; Male of childbearing age: Take contraceptive measures during surgical sterilization or treatment and within 3 months after completion; 8. Understand and voluntarily sign a written informed consent form;
Exclusion criteria
Exclusion criteria: 1. The pathological type is small cell lung cancer, or a mixed type of lung cancer that includes small cell lung cancer. 2. The pathological type is adenocarcinoma with EGFR/ALK/ROS1 positive mutations; 3. Participants in this study have received any systemic anti-tumor treatment, including chemotherapy, radiation therapy, immunotherapy (including but not limited to anti-PD-1, anti-PD-L1, anti-PD-L2 drugs or drugs acting on another co inhibitory T cell receptor), or targeted therapy (including but not limited to monoclonal antibodies, small molecule tyrosine kinase inhibitors, etc.); 4. The patient has been previously diagnosed with other malignant tumors; 5. Previous interstitial lung disease, drug-induced interstitial disease, or any clinically proven active interstitial lung disease; At baseline, CT scan revealed the presence of idiopathic pulmonary fibrosis; 6. Evidence of serious or uncontrollable systemic diseases, such as unstable or uncompensated respiratory, cardiac, liver, or kidney diseases, as determined by researchers; 7. Any unstable systemic disease (including active infections, grade III hypertension, unstable angina, congestive heart failure, liver, kidney, or metabolic disorders); 8. Having a clear history of neurological or mental disorders, including epilepsy or dementia; 9. Severe chronic or active infections that require systemic antibacterial, antifungal, or antiviral treatment, including tuberculosis infection; 10. Known to have active hepatitis B, hepatitis C, human immunodeficiency virus (HIV) infection, or other infectious diseases deemed unsuitable for inclusion; 11. Individuals who are known to have severe allergies to Slulimumab, investigational chemotherapy drugs, and/or any of their excipients; 12. Pregnant or lactating women; 13. Other researchers believe that it is not possible to join the group.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main pathological relief; | — |
Secondary
| Measure | Time frame |
|---|---|
| Pathologic complete response;Objective response rate;Adverse event incidence rate; | — |
Countries
China
Contacts
Public ContactZeng Jian
Zhejiang cancer hospital
Outcome results
None listed