lung cancer
Conditions
Interventions
experimental group:Peampriumab neoadjuvant therapy + neoadjuvant chemotherapy
Sponsors
Department of Thoracic Surgery, The Second Affiliated Hospital of Army Medical University
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1. Subjects voluntarily join the study and sign the informed consent; 2. Age >= 18 years old when signing the informed consent form, male or female; 3. Patients with non-small cell lung cancer confirmed by histopathology or cytology (according to WHO 2015 classification); 4. Patients with operable stage II-IIIA non-small cell lung cancer (judged according to the 8th edition of the International Association for the Study of Lung Cancer (IASLC) Thoracic Tumor Staging Manual); and the primary tumor or lymph node metastasis is clearly detected; 5. EGFR/ALK/ROS1 negative; 6. Never received any treatment for NSCLC before; 7. According to the Response Evaluation Criteria for Solid Tumors (RECIST1.1), there is at least one single-diameter measurable lesion, the longest diameter of which is >= 10 mm measured by spiral CT; 8. Eastern Cooperative Oncology Organization (ECOG) physical status score is 0 or 1; 9. The estimated survival period is not less than 12 weeks; 10. Male and female patients of reproductive age agree to use reliable methods of contraception before entering the study, during the study, and within 8 weeks after stopping the drug; 11. Patients who agree to receive surgical treatment; 12. Patients with no surgical contraindications judged by specialists. The main organ functions are normal and should meet the following criteria: 13. Pulmonary ventilation function test, FEV1 >= 1.5 L, or estimated FEV1 >= 800 ml after lobectomy/pneumonectomy; 14. Blood routine test standard (no blood transfusion and blood products within 14 days, no correction with G-CSF and other hematopoietic stimulating factors): (1) Hemoglobin (HB) >= 90 g/L; (2) Absolute neutrophil count (ANC) >= 1.5 × 10^9/L; (3) Platelets (PLT) >= 80 × 10^9/L; 15. Biochemical examination must meet the following indicators: (1) Total bilirubin (TBIL) = 60 ml/min; 16. Women of childbearing age (15-49 years old) must have a urine pregnancy test within 7 days before starting treatment and the result is negative.
Exclusion criteria
Exclusion criteria: 1. Small cell carcinoma, large cell carcinoma and mixed cell lung cancer; 2. Any systemic anticancer treatment for NSCLC, including cytotoxic drug therapy, immunotherapy, experimental therapy, etc.; 3. Local radiotherapy for NSCLC; 4. Within 4 weeks before enrollment or during the 5 half-lives of the drug (whichever is longer), use systemic immune stimulants (including but not limited to interferon, interleukin 2, tumor necrosis factor) for treatment (allowing previous treatment use of cancer vaccines); 5. Within 14 days before the first administration of the study drug, any Chinese herbal medicine used to control cancer was used; 6. Suffering from any disease that must use corticosteroids (prednisone > 10 mg/day or equivalent treatment) or other immunosuppressive drugs for systemic treatment within 14 days before enrollment [Patients who currently or previously used any of the following steroid regimens can Inclusions: Epinephrine replacement steroids (prednisone = 100 mmHg); (2) Suffering from grade I or above myocardial ischemia or myocardial infarction, arrhythmia (including QTc >= 480 ms) and >= grade 2 congestive heart failure (New York Heart Association (NYHA) classification); (3) Active or uncontrolled severe infection; (4) Liver cirrhosis, decompensated liver disease, active hepatitis or chronic hepatitis require antiviral treatment; (5) Renal failure requires hemodialysis or peritoneal dialysis; (6) Those with a history of immunodeficiency, including those who are HIV positive or suffer from other acquired or congenital immunodeficiency diseases, or have a history of organ transplantation; (7) Poorly controlled diabetes (fasting blood glucose (FBG) > 10 mmol/L); (8) Patients who have epileptic seizures and need treatment; (9) Long-term unhealed wounds or fractures, etc.; 10. Previously suffered from interstitial lung disease, drug-induced interstitial disease, radiation pneumonitis requiring hormone therapy, or any active interstitial lung disease with clinical evidence; 11. Hyperactive/venous thrombosis events within 6 months, such as cerebrovascular accidents (including transient ischemic attacks), deep vein thrombosis and pulmonary embolism; 12. Currently there is peripheral neuropathy of >= CTCAE 2 degree, except for trauma; 13. For subjects who have undergone major surgery or severe trauma, the effects of surgery or trauma have been eliminated for less than 14 days before enrollment; 14. Patients are participating in other clinical studies or less than 4 weeks before the end of treatment in the previous clinical study; 15. Received live vaccines or attenuated vaccines wi
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Complete Pathological Response Rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| major pathologic response rate;objective response rate;R0 resection rate;1-year disease-free survival rate;disease-free survival;overall survival;Adverse Effects Rate; | — |
Countries
China
Contacts
Public ContactJigang Dai
The Second Affiliated Hospital of Army Medical University
Outcome results
None listed