non-small cell lung cancer
Conditions
Interventions
Treatment Group:Navullizumab 3mg/kg, intravenous infusion, the infusion time was 60min, 4, 2 weeks before the surgery once each.Surgery was performed 4 weeks after the first drug administration.Radica
Control Group:Surgical resection was performed as soon as possible after the completion of preoperative evaluation after enrollment.Radical surgery (lobectomy or pneumonectomy combined with mediastina
Sponsors
Shanghai Pulmonary Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. informed consent has been signed; 2. ability to follow the study protocol and follow up procedures; 3. the patient is at least 18 years old; 4. confirmed by histology and cytology preoperative NCLC (biopsy), chest CT, liver and adrenal CT, head mri and PET - CT/whole body bone imaging such as clear as IIB (> 5 cm), IIIA (N1) of patients treated first (according to the NCCN 2017 staging criteria); 5. the patient must have a measurable lesion (per RECIST 1.0 criteria); 6. adequate lung function to tolerate surgery; 7. ECOG score for physical condition is 0 ~ 1; 8. life expectancy is at least 12 weeks; 9. the following laboratory tests conducted within 7 days before the first drug use confirmed that the patient's bone marrow, liver and kidney functions met the requirements for participating in the study: 10. hemoglobin greater than or equal to 9.0 g/dL (which can be maintained or exceeded by blood transfusion); 11. red blood cell count is greater than or equal to 2.0 x 10^9/L; 12. absolute neutrophil count (ANC) greater than or equal to 1.0x10^9/L; 13. platelet count greater than or equal to 100 x 10^9/L; 14. total bilirubin is within the normal limit; 15. upper limit of normal value of alanine glutamate transaminase, straw glutamate transaminase and alkaline phosphatase less than 2.5 times; 16. creatinine less than or equal to 2.0 mg/dL;Creatinine clearance rate was greater than or equal to 60ml/min. 17. the international standardized ratio of prothrombin time (INR) is less than or equal to 1.5 in patients who have not received anticoagulation therapy, and the upper limit of partial thrombin time (APTT) is less than or equal to 1.5 times the normal value.Patients receiving full or extra-gastrointestinal anticoagulant therapy can enter the clinical trial as long as the dose of anticoagulant is stable for at least 2 weeks before entering the clinical study, and the results of the coagulation test test are within the limits of local treatment. Women of child-bearing age must undergo a pregnancy test within 7 days before starting treatment and the results are negative. Men and women of appropriate age must use a reliable method of contraception until 30 days after drug withdrawal before entering the trial.Reliable contraceptive methods will be determined by the principal investigator or designee.
Exclusion criteria
Exclusion criteria: 1. active, known, or suspected autoimmune diseases.(vitiligo, ? diabetes, need hormone replacement therapy caused by autoimmune thyroiditis JiaJian, and other autoimmune disease patients without recurrence can be incorporated into); 2. any systemic anticancer therapy for NSCLC, including cytotoxic drug therapy, targeted therapy, immunotherapy and experimental therapy; 3. surgical treatment of NSCLC; 4. local radiotherapy for NSCLC; 5. patients with cancer other than NSCLC within 5 years prior to the start of treatment in this study.Other than non-melanoma skin cancer, bladder cancer in situ/stomach cancer/colon cancer/breast cancer/cervical cancer; 6. any unstable systemic disease (including active infection, out of control of high blood pressure, unstable angina, angina onset within the past 3 months, congestive heart failure (or greater New York heart association (NYHA) class II), all infarction (group into the first 6 months), need drug therapy of severe arrhythmia, liver, kidney or metabolic disease; 7. previous or present interstitial lung disease; 8. systemic infections requiring treatment, HBV surface antigen positive or HCV RNA positive; 9. past or present detection of human immunodeficiency virus (HIV) or AIDS; 10. allergy to research drugs; 11. patients who underwent major surgery or suffered severe trauma within 2 months prior to the first medication; 12. any malabsorption; 13. women who are pregnant or breast-feeding; 14. situations that other researchers consider unsuitable for enrollment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| safety;Pathological remission rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Disease-free survival;5-year overall survival;Relapse Rate; | — |
Countries
China
Contacts
Public ContactZhang Peng
Shanghai Pulmonary Hospital
Outcome results
None listed