Lung cancer
Conditions
Interventions
Experimental group:sintilimab combined with platinum-containing dual drug chemotherapy
Sponsors
The Second Affiliated Hospital of Shandong First Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Sign written informed consent before implementing any trial-related procedures; 2. Male or female aged 18 to 75 years; 3. Cytological or histological diagnosis of non-small cell lung cancer; 4. According to the Response Evaluation Criteria for Solid Tumors (RECIST version 1.1), at least one lesion with measurable imaging findings; 5. Non-small cell lung cancer patients with stage Ib-IIIa without any treatment (according to UICC/AJCC 8th edition TNM staging); 6. Biopsy specimens can be obtained from the primary tumor; 7. Patients who agree to undergo radical surgery; 8. Patients who are resectable and have no contraindications to surgery are evaluated by a surgeon; 9. ECOG score 0-1 points; 10. Expected survival time > 6 months; 11. Sufficient organ function, subjects should meet the following laboratory indicators: (1) No use in the past 14 days (in the case of granulocyte colony-stimulating factor, the absolute value of neutrophils (ANC) is >= 1.5 x 10^9/L. (2) Platelets >= 100 x 10^9/L without blood transfusion in the past 14 days. (3) Hemoglobin > 9g/dL without blood transfusion or erythropoietin in the past 14 days; (4) Total bilirubin = 60 ml/min; (7) Good coagulation function, defined as international normalized ratio (INR) or prothrombin time (PT) <= 1.5 times ULN; (8) Normal thyroid function, defined as thyroid-stimulating hormone (TSH) within the normal range. If the baseline TSH exceeds the normal range, subjects with total T3 (or FT3) and FT4 within the normal range can also be enrolled; (9) Myocardial enzyme spectrum is within the normal range (if the investigator comprehensively judges that the simple laboratory abnormality does not have clinical significance, it is also allowed to enter the group). 12. For female subjects of childbearing age, a negative urine or serum pregnancy test should be performed within 3 days prior to receiving the first dose of study drug (Day 1 of Cycle 1). If a urine pregnancy test result cannot be confirmed negative, a blood pregnancy test is required. Women of non-reproductive age are defined as having been postmenopausal for at least 1 year, or have undergone surgical sterilization or hysterectomy; If there is a risk of conception, all subjects (whether male or female) are required to use an annual failure rate of less than 1 throughout the treatment period up to 120 days after the last dose of study drug (or 180 days after the last dose of chemotherapy) % of contraception.
Exclusion criteria
Exclusion criteria: 1. Diagnosed with other malignant diseases other than non-small cell lung cancer within 5 years before the first administration (excluding basal cell carcinoma of the skin, squamous epithelial carcinoma of the skin, and/or carcinoma in situ after radical resection); 2. Currently participating in interventional clinical research treatment, or have received other investigational drugs or used investigational device treatment within 4 weeks before the first dose; 3. Previous therapy with anti-PD-1, anti-PD-L1, or anti-PD-L2 drugs or against another stimulating or synergistic inhibitory T cell receptor (eg, CTLA-4, OX-40, CD137) drug; 4. Received systemic systemic treatment of Chinese patent medicines with anti-tumor indications or immunomodulatory drugs (including thymosin, interferon, interleukin, except for local use for controlling pleural effusion) within 2 weeks before the first administration; 5. Active autoimmune disease requiring systemic treatment (such as the use of disease-modifying drugs, glucocorticoids or immunosuppressants) has occurred within 2 years before the first dose. Replacement therapy (such as thyroxine, insulin, or physiological corticosteroids for adrenal or pituitary insufficiency, etc.) is not considered systemic therapy; 6. Those who are receiving systemic glucocorticoid therapy (excluding nasal spray, inhalation or other local glucocorticoids) or any other form of immunosuppressive therapy within 7 days before the first dose of the study; Note: Physiological doses of glucocorticoids (= grade 2; (3) Any arterial thrombosis, embolism or ischemia, such as myocardial infarction, unstable angina pectoris, cerebrovascular accident or transient cerebral ischemic attack, occurred within 6 months before the selected treatment; (4) Unsatisfactory blood pressure c
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Major pathological remission;Event-free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Pathological complete remission;Overall Survival;Disease-free survival;Objective remission rate;Adverse event;Non-delayed operation rate;Postoperative complications; | — |
Countries
China
Contacts
Public ContactLiu Haiyan
The Second Affiliated Hospital of Shandong First Medical University
Outcome results
None listed