Lung cancer
Conditions
Interventions
A group (Patients who have not reached pCR):None
B group (Patients who have reached pCR):None
Sponsors
General Hospital of Ningxia Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Age =18 years old, < 70 years old; 2. No previous treatment related to tumor disease (including radiotherapy and chemotherapy, targeting, immunization or traditional Chinese medicine treatment); 3. Histologically proven stage II to IIIB non-small cell lung cancer (as defined by AJCC 9th Edition/International Union against Cancer NSCLC Staging System) 4. Have a measurable disease assessed by the investigator according to RECIST version 1.1 5. After evaluation by the thoracic surgeon, it is confirmed that the requirements for R0 excision for the purpose of radical treatment are met 6. ECOG score 0~1; 7. Patients are asked to provide archived tumor tissue samples (FFPE tissue blocks or approximately 15 [=6] newly cut unstained FFPE slices) and pathology reports of this baseline sample for PD-L1 and other biomarkers analysis (at least 6 additional slices if the patient requires EGFR testing). If no archived samples are available or samples are not available, a biopsy sample is required at baseline. 8. If the major organs function normally, the following criteria are met: (1) Patients should not receive blood transfusion or growth factor support within =14 days before blood collection during the screening period; Within 7 days before blood routine randomization, the following laboratory indicators must meet the following results: Absolute neutrophil count =1.5 x 109/L Platelet =75×109/L Hemoglobin =90 g/L (2) The International standardized ratio (INR) =2.3 or the prothrombin time (PT) exceeds the normal control range =6 seconds; (3) Urine protein <2+ (if urine protein =2+, 24 hours (h) urine protein quantification can be performed, 24 hours (h) urine protein quantification <1.0 g can be included in the group); Note: International Standardized ratio (INR) or prothrombin time (PT)=1.5× upper limit of normal (ULN); Activated partial thromboplastin time (aPTT)=1.5×ULN; Serum total bilirubin =1.5×ULN(Gilbert syndrome patients must have total bilirubin <3×ULN); Aspartate and alanine aminotransferase (AST and ALT)=2.5×ULN, or AST and ALT=5×ULN in patients with liver metastasis; 9. Voluntarily join the study and sign the informed consent; 10. Life expectancy =3 months.
Exclusion criteria
Exclusion criteria: 1. Pneumonia, upper gastrointestinal bleeding, esophageal fistula, esophageal perforation, or chest abscess occurred within 6 months before the start of study treatment; 2. A history of active autoimmune disease or autoimmune disease that may recur. (such as interstitial pneumonia, uveitis, enteritis, hepatitis, pituitaritis, vasculitis, myocarditis, nephritis, hyperthyroidism, hypothyroidism (can be included after hormone replacement therapy); Note: Patients with the following diseases are not excluded and may be further screened: • Hypothyroidism (as long as it is treated with hormone replacement therapy alone) • Well-controlled type 1 diabetes • Well-controlled celiac disease • Skin conditions that do not require systemic treatment (e.g. Vitiligo, psoriasis, hair loss) Any other medical condition that is not expected to recur in the absence of external triggers; 3. Any active malignant tumor =2 years prior to entry, except for the specific cancer examined in this study and any locally recurrent cancer that has been eradicated (e.g., resected basal or squamous cell skin cancer, superficial bladder cancer, cervical or breast carcinoma in situ); 4. Have congenital or acquired immunodeficiency, such as human immunodeficiency virus (HIV) infection, active hepatitis B (HBV DNA = 500 IU/ml), hepatitis C (HCV antibody positive, and HCV-RNA above the lower detection limit of analytical methods) or co-infection with hepatitis B and hepatitis C; 5. Any previous treatment for your current lung cancer, including chemotherapy or radiation 6. Live vaccines were administered within =4 weeks before randomization. Note: Seasonal influenza vaccines are usually inactivated vaccines, and patients receiving such vaccines are allowed to be enrolled. Intranasal influenza vaccine is live vaccine, and patients receiving such vaccine are not allowed to enroll; 7. Patients with clinically uncontrolled pleural effusion or ascites requiring pleural puncture or peritoneal puncture drainage within 2 weeks prior to randomization, or those who had received pleural and peritoneal fluid drainage within 3 months prior, except those who showed a small amount of pleural effusion or peritoneal fluid without clinical symptoms on medical imaging; 8. Pericardial effusion with clinical significance; 9. Severe chronic or active infections that require systemic antimicrobial, antifungal or antiviral treatment, including tuberculosis infections. 10. Treatment with systemic immune stimulants (including, but not limited to, interferon, interleukin 2, tumor necrosis factor) within 4 weeks prior to randomization or within 5 half-lives of the drug, whichever is older (cancer vaccines allowed in previous treatment); 11. Participate in another therapeutic clinical study. Note: Simultaneous participation in observational or non-interventional studies is permitted; 12. Pregnant or breastfeeding women; 13. Any condition which, in the opinion of the investigator, is likely to harm the subject or cause the subject to be unable to meet or perform the study requirements; 14. Patients with EGFR/ALK sensitive mutations; 15. Known allergic reactions, hypersensitivities or intolerances to immunosuppressants or their excipients;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| pCR; | — |
Secondary
| Measure | Time frame |
|---|---|
| EFS;OS;MPR; | — |
Countries
China
Contacts
Public ContactJinxi He
General Hospital of Ningxia Medical University
Outcome results
None listed