Non-small cell lung cancer
Conditions
Interventions
Single-Arm Group:This study adopts the Simon two-stage optimal design. In the first stage, 16 subjects will be enrolled. If pCR is observed in more than 3 of the 16 subjects, the study will proceed to
Radical surgery (R0 resection) should be performed within 4 to 6 weeks after the last administration. Postoperative adjuvant therapy with evoximab (20mg/kg, Q3W, IV)
Sponsors
The Second Affiliated Hospital of Air Force Military Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. The subjects voluntarily joined this study, were able to complete the signing of the informed consent form, and had good compliance. 2. Age: 18 to 75 years old (at the time of signing the informed consent form), both men and women are acceptable. 3. Histologically confirmed as stage IIA to IIIB (IIIB stage T2/3/4N2) non-small cell lung cancer (staging based on AJCC 9th Edition); 4. Has not received any previous local treatment (surgery or radiotherapy) for NSCLC or any previous systemic anti-tumor therapy, including cytotoxic therapy, targeted therapy (including tyrosine kinase inhibitors or monoclonal antibodies), cell therapy, immunotherapy, traditional Chinese medicine therapy, or any other investigated drug therapy; 5. ECOG PS score 0-1; 6. Expected survival period >=3 months; 7. Patients are required to provide archived tumor tissue samples (FFPE tissue blocks or approximately >=6 newly cut unstained FFPE sections) and the pathological report of this baseline sample for PD-L1 and other biomarker analysis. If there are no available archived samples or the samples are not available, a biopsy sample should be taken at baseline. 8. Have sufficient organ and bone marrow functions, and the laboratory test values within 7 days before enrollment meet the following requirements: (1) Blood routine: Absolute neutrophil count (ANC) >=1.5×10^9/L, platelet count (PLT) >=75×10^9/L, hemoglobin (HGB) >=90 g/L (no blood transfusion or erythropoietin dependence within 14 days); (2) Liver function: Serum total bilirubin (TBIL) =45 mL/min/1.73 m^2 (4) Coagulation function: International normalized ratio (INR) or prothrombin time (PT) <=1.5 times ULN; 9. For female subjects of childbearing age, a urine or serum pregnancy test should be conducted three days before the first administration of the study drug, and the result should be negative. 10. After assessment by a thoracic surgeon, it was confirmed that the requirements for R0 resection for radical treatment purposes were met. 11. The researchers evaluated it as a measurable disease according to RECIST version 1.1.
Exclusion criteria
Exclusion criteria: 1. Those with a known history of central nervous system metastases; 2. Patients with EGFR mutations or ALK translocations; (1) For patients with non-squamous cell carcinoma, EGFR test results based on tumor tissue must be provided. If the EGFR mutation status is unknown, EGFR testing must be conducted before enrollment. (2) For patients with squamous non-small cell lung cancer, if the EGFR mutation status is unknown, testing is not required during screening. (3) Patients with unknown ALK fusion gene status (whether non-squamous cell carcinoma or squamous cell carcinoma) are not required to undergo testing. 3. Previously used treatments targeting TROP2 and/or topoisomerase I inhibitors; 4. Previously received treatment with immune checkpoint inhibitors, including but not limited to anti-cytotoxic T lymphocyte-associated antigen-4 (anti-CTLA-4), anti-PD-1 and anti-PD-L1 therapeutic antibodies, and OX-40; 5. Currently participating in an intervention clinical trial, or having received other investigational drugs or medical intervention measures within 4 weeks; 6. There is a known history of allergy to the drugs and their components in this plan; 7. Active autoimmune diseases require systemic treatment or a history of autoimmune diseases that may recur. 8. Patients who need long-term systemic use of glucocorticoids (those who need to use inhaled or locally injected glucocorticoids due to COPD or asthma can be enrolled), or those who have received immunosuppressant therapy within 7 days before treatment; 9. There is an active infection that requires treatment or systemic anti-infective drugs have been used within one week before the first administration; 10. Have a history of interstitial lung disease, non-infectious pneumonia or poorly controlled diseases, including pulmonary fibrosis, acute lung disease, etc. 11. Known history of human immunodeficiency virus (HIV) infection, untreated active hepatitis B (defined as HBsAg positive and HBV-DNA copy number greater than 2000 IU/ml detected, active HCV-infected subjects (HCV antibody positive and HCV-RNA level higher than the detection limit); 12. Has undergone allogeneic stem cell transplantation or organ transplantation in the past. 13. Have received a live vaccine within 30 days before the first administration (day 1 of the first cycle); 14. Pregnant or lactating women; 15. Medical history or disease evidence that may interfere with the trial results, prevent the subjects from participating in the entire study, abnormal treatment or laboratory test values, or other circumstances that the researchers consider unsuitable for enrollment. The researchers believe there are other potential risks that make the subjects unsuitable for participating in this study. 16. Patients with stage IIIB excluding TxN3 non-small cell lung cancer (staging based on AJCC Edition 9); Renal insufficiency: Urine routine test indicates urine protein >=++, or 24-hour urine protein quantity >=1.0 grams after diagnosis.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pathological Complete Response (pCR) Rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Major Pathological Response (MPR) Rate;Event-Free Survival (EFS);Objective Response Rate (ORR); | — |
Countries
China
Contacts
Public ContactYan Xiaolong
The Second Affiliated Hospital of Air Force Military Medical University
Outcome results
None listed