Patients with driver gene (EGFR/ALK/ROS1) -negative, unresectable stage II-IIIA (N2) NSCLC
Conditions
Interventions
experimental group:Durvalumab
Sponsors
Air Force Medical Center
Eligibility
Sex/Gender
Male
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Sign the informed consent form; 2. Aged > 18 years; 3. histologically or cytologically confirmed non-small cell lung cancer, and measurable lesions according to RECIST1.1 criteria; 4. ECOG score 0-1; 5. Expected survival >= 12 weeks; 6. Include patients with driver gene (EGFR/ALK/ROS1) -negative, untreated stage II-IIIA (N2) NSCLC; 7. Patients did not receive previous anti-angiogenic small molecule targeted drugs before enrollment; 8. Systemic corticosteroids (prednisone > 10 mg/day or equivalent) have been discontinued for at least 2 weeks before enrollment; 9. Major surgery requiring general anesthesia must have been completed for at least 8 weeks; surgery requiring local anesthesia/epidural anesthesia must have been completed for at least 4 weeks; 10. Blood routine requirements: hemoglobin >= 90 g/L (no blood transfusion is allowed), neutrophils >= 1.5 x 10^9/L (14 before the test without recombinant human granulocyte colony-stimulating factor support therapy), platelets >= 100 x 10^9/L (7 before the test without recombinant human thrombopoietin or blood transfusion and other supportive therapy); 11. Serum creatinine = 60 mL/min (Cockcroft-Gault formula), and urine protein = 2 + or >= 1.0 g/L, 24-hour urine protein quantitative test should be performed and must be <= 1.0 g/L to be included; 12. Total bilirubin <= 1.5 x ULN (unless confirmed Gilbert's syndrome), aspartate aminotransferase (AST) and alanine aminotransferase (ALT) <= 2.5 x ULN (AST and/or ALT <= 5 x ULN are allowed for patients with liver metastases); 13. Thyroid function indicators: thyroid stimulating hormone (TSH), free thyroxine (FT3/FT4) in the normal range; 14. Adverse reactions caused by previous treatment recover to grade 1 or lower before enrollment (except alopecia and neurotoxicity <= grade 2 caused by chemotherapeutic drugs); 15. Women who are confirmed not to be pregnant within 7 days before administration, and men or women of reproductive age should agree to take medically recognized effective contraceptive measures throughout the trial and within 6 months after the end of the trial; 16. Patients can be followed up on schedule, can communicate well with the investigator and can complete the study in accordance with the study regulations.
Exclusion criteria
Exclusion criteria: 1. Active central nervous system (CNS) metastasis, including symptomatic brain metastasis or meningeal metastasis or spinal cord compression; asymptomatic brain metastasis can be (at least 4 after radiotherapy without progression and/or no neurological symptoms or signs after surgical resection, without the need for glucocorticoids, antiepileptic drugs, anticonvulsants or mannitol treatment); 2. Patients with other previous malignancies (except cured cervical carcinoma in situ and cutaneous basal cell carcinoma) should not participate in the study, unless he/she has been in complete remission for at least 2 years before enrollment and does not require other treatment or does not require other treatment during the study; 3. A history of active, known autoimmune diseases, including but not limited to systemic lupus erythematosus, psoriasis, rheumatoid arthritis, inflammatory bowel disease, Hashimoto's thyroiditis, etc., except: type I diabetes, hypothyroidism that can be controlled by hormone replacement therapy alone, skin diseases that do not require systemic treatment (such as vitiligo, psoriasis) and controlled celiac disease; 4. Previous treatment with anti-PD-1 antibody, anti-PD-L1 antibody, anti-PD-L2 antibody or anti-CTLA-4 antibody (or any other antibody acting on T cell costimulation or checkpoint pathway); 5. Uncontrolled hypertension (systolic blood pressure >= 140 mmHg and/or diastolic blood pressure >= 90 mmHg) or pulmonary hypertension or unstable angina pectoris; myocardial infarction or bypass, stent surgery within 6 months before administration; New York Heart Association (NYHA) criteria grade 3-4 history of chronic heart failure; clinically significant valvular disease; severe arrhythmia requiring treatment (except atrial fibrillation, paroxysmal supraventricular tachycardia), including QTc interval >= 450 ms in men and >= 470 ms in women (calculated by Fridericia formula); cerebrovascular accident (CVA) or transient ischemic attack (TIA) within 12 months before administration; 6. Patients with a history of arterial thrombosis or deep venous thrombosis within 6 months before enrollment, or with evidence or history of bleeding tendency within 2 months before enrollment, regardless of severity; partial prothrombin time (APTT) or prothrombin time (PT) > 1.5 x ULN; 7. Skin wounds, surgical sites, wound sites, severe mucosal ulcers or fractures are not completely healed; 8. Imaging shows signs of tumor invasion into the great vessels, including complete proximity, encasement, or invasion of the tumor into the lumen of the great vessels (e.g., pulmonary artery or superior vena cava); 9. dysphagia or known drug absorption disorder; 10. Gastrointestinal disorders that will significantly affect the absorption of oral drugs or conditions that may cause gastrointestinal bleeding or perforation (such as duodenal ulcer, intestinal obstruction, acute Crohn's disease, ulcerative colitis, massive gastric and small intestinal resection, etc.); Patients with chronic Crohn's disease and ulcerative colitis (except those with total colon and rectal resection), even in the inactive phase, should be excluded. Patients with hereditary nonpolyposis colorectal cancer or familial adenomatous polyposis syndrome. Patients with previous history of intestinal perforation and intestinal fistula who did not recover after surgical treatment; 11. Current or previous interstitial pneumonia; 12. Uncontrolled thoracoabdominal and peric
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| EFS; | — |
Countries
China
Contacts
Public ContactHuaiyu Wang
Air Force Medical Center
Outcome results
None listed