Early surgical removal of non-small cell lung cancer
Conditions
Interventions
experiment group:Ivonescimab
control group:Penpulimab Injection
Sponsors
Peking University People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Voluntarily signed the written informed consent form (ICF) and agreed to undergo radical surgical treatment; 2. Age >=18 years old at the time of enrollment, male or female; 3. Eastern Cooperative Oncology Organization (ECOG) performance status score of 0~1; 4. Histologically confirmed resectable stage IIA-IIIB(N2) NSCLC (according to the International League Against Cancer and the American Joint Committee on Cancer 9th edition TNM staging of lung cancer) :(1) For stages assessed as T4, only subjects with a primary tumor > 7cm are allowed to be enrolled (if the tumor invades the diaphragm, mediastinum, heart, large blood vessels, trachea, recurrent laryngeal nerve, esophagus, vertebral body, carina, or there are independent tumor nodules in different ipsilateral lung lobes); (2) Whether the subject can be enrolled can be judged according to the clinical stage, but it is recommended to record the subject's lymph node involvement through endobronchial ultrasound or mediastinoscopy before surgery; (3) Only NSCLC subjects with resectable T3N2 or T4N2 can be enrolled in stage IIIB; (4) NSCLC patients with mixed NSCLC histological characteristics (squamous and non-squamous) or not clearly stated can be enrolled; (5) Whether the patient can be enrolled can be judged according to the clinical stage, but it is strongly recommended to record the lymph node involvement of the patient through endobronchial ultrasound or mediastinoscopy before surgery; 5. Before enrollment in the study, subjects need to be evaluated by a attending thoracic surgeon in charge of surgery to verify whether they meet the study requirements for R0 resection for the purpose of radical cure. 6. Non-small cell lung cancer is solid or subsolid on CT scan, not simply ground-glass opaque (GGO). For subsolid lesions, tumor size (i.e., clinical T stage) should be based only on the solid tumor portion and does not have to measure the ground-glass opaque part; 7. Pulmonary function tests will be performed on the subject within 6 months before the planned resection, and if clinically indicated, it can be tested again at screening, including lung volume, respiratory spirometry and diffusion capacity: (1) If the pulmonary function test results are abnormal, further evaluation can be made by quantitative ventilation/perfusion scan cardiopulmonary exercise test; (2) Postoperatively, forced respiratory volume per second should be performed to predict forced expiratory volume percentage (FEV1%), and the predicted percentage must be >=40%; 8. At least one measurable lesion according to RECIST v1.1, and according to RECIST v1.1, the lesion is suitable for repeated and accurate measurement; 9. Good cardiac function confirmed to meet the requirements for surgical resection for the purpose of curative treatment. If clinically indicated, a cardiologist should preoperatively evaluate the subject for underlying conditions such as ischemia, valvular disease, or other major heart disease. 10 During the screening process or =1.5L, or expected FEV1>=800ml after lobe/pneumonectomy; 2) Hematology (no blood components and cell growth factor supportive therapy within 14 days before blood draw): i. Absolute neutrophil ANC>=1.5×10^9/L; ii. Platelet count >=100×10^9/L; iii. Hemoglobin >=90 g/L 3) Renal i. Creatinine cl
Exclusion criteria
Exclusion criteria: 1. Patients with large cell neuroendocrine carcinoma (LCNEC) and small cell lung cancer; 2. Presence of locally advanced, unresectable disease, regardless of disease stage and presence of metastases (stage IV). PET-CT scan assessed subjects with contralateral mediastinal lymph node involvement. 3. Diagnosed with NSCLC with EGFR sensitivity mutation or ALK gene translocation. (1) For subjects with non-squamous cell carcinoma (including NSCLC with unclear pathological type), EGFR and ALK test results based on tumor tissue must be provided. If the EGFR mutation and ALK gene translocation status are unknown, EGFR mutation and ALK gene translocation must be detected before enrollment. (2) For subjects with squamous non-small cell lung cancer, if the EGFR mutation and ALK gene translocation status are unknown, testing is not required at screening. 4. Any systemic or local anti-tumor therapy for NSCLC, including cytotoxic drug therapy, immunodrug therapy, radiotherapy, experimental therapy, biological agents, small molecule targeted therapy, etc.; 5. Enrollment in another clinical study at the same time, unless it is a non-interventional clinical study or the follow-up period of an interventional study (defined as the time of first dose is more than 4 weeks from the last dose of the previous clinical study or more than 5 half-lives of the investigational drug, whichever is shorter); 6. Palliative local treatment for non-target lesions within 2 weeks before randomization; Received non-specific immunomodulatory therapy (such as interleukin, interferon, thymus peptide, tumor necrosis factor, etc.) within 2 weeks before the first dose, excluding IL-11 for the treatment of thrombocytopenia; Systematic receipt of Chinese herbal medicines or proprietary Chinese medicines with anti-tumor indications within 1 week before the first dose; 7. Other malignant tumors other than NSCLC within 3 years prior to randomization; Subjects with other malignancies that have been cured by local therapy, such as basal or cutaneous squamous cell carcinoma, superficial bladder cancer, cervical or breast carcinoma in situ, are allowed to be included; 8. Active autoimmune disease requiring systemic treatment (such as treatment with disease-modifying drugs, corticosteroids, immunosuppressants) within 2 years prior to randomization (excluding irAEs caused by PD-1/L1 inhibitors). Replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a systemic treatment; Note: Patients with the following conditions do not need to be excluded and may continue for further screening: • Well-controlled type I diabetes mellitus • Hypothyroidism (as long as treated with hormone replacement therapy alone) • Well-controlled celiac disease • Skin disorders that do not require systemic therapy (e.g., vitiligo, psoriasis, alopecia) • Any other disease that is not expected to recur in the absence of external triggers; 9. History of major illness within 1 year prior to randomization, specifically: ? Unstable angina, myocardial infarction, congestive heart failure requiring hospitalization within 12 months prior to randomization (New York Heart Association NYHA classification>). =Grade 2) or vascular disease (such as aortic aneurysm at risk of rupture), or other cardiac damage that may affect the safety evaluation of the study drug (such as poorly controlled arrhythmias, myocardial ischemia, etc.); ? History
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pathological complete response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Event-free survival period;Main pathological remission rate; | — |
Countries
China
Contacts
Public ContactFan Yang
Peking University People's Hospital
Outcome results
None listed