??Treatment-naïve, surgically resectable stage II-III NSCLC?
Conditions
Interventions
Test group:Adebrelimab Combined with Chemotherapy and Imatinib as Neoadjuvant therapy
Sponsors
Peking University People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Age >=18 years, regardless of gender. 2. Histologically or cytologically confirmed, surgically treatable stage II-III NSCLC (stage II, IIIA, and T3N2M0 IIIB) patients, according to the 8th edition of the UICC and AJCC TNM staging for lung cancer; non-bulky metastatic (lymph nodes with short diameter =1.5×10?/L,b. Platelet count (PLT) >=100×10?/L,c. Hemoglobin (HB) >=90 g/L,d. Absolute lymphocyte count (LC) >=0.5×10?/L.(2) Liver function: Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =3 g/dL.(3) Renal function: Creatinine clearance rate (CrCl) >=45 mL/min (calculated using the Cockcroft-Gault formula).(4) Coagulation function: International normalized ratio (INR) <= 1.5, activated partial thromboplastin time (APTT) <= 1.5×ULN. 8. Women of childbearing potential must have a negative urine or serum pregnancy test within 7 days before starting study treatment and agree to use a medically approved highly effective contraceptive method (e.g., intrauterine device, oral contraceptives, or condoms) during the study and for 180 days after the last dose of study drug. Male subjects with partners of childbearing potential must agree to use effective contraception during the study and for 180 days after the last dose of study drug. 9. Subjects voluntarily join this study, sign the informed consent form, have good compliance, and cooperate with follow-up.
Exclusion criteria
Exclusion criteria: 1. Known EGFR or ALK mutations. 2. T4 tumors invading the heart, great vessels, trachea, recurrent laryngeal nerve, esophagus, vertebral body, or carina; T4 tumors with scattered nodules in different lobes of the same lung; Pancoast tumors. 3. Prior systemic antitumor therapy for NSCLC; if prior Chinese herbal antitumor therapy was received, a washout period of at least 2 weeks from the end of herbal treatment to the first dose is required for eligibility. 4. Use of immunosuppressive drugs within 4 weeks before the first dose of study drug, excluding intranasal or inhaled corticosteroids or physiological doses of systemic corticosteroids (i.e., no more than 10 mg/day prednisolone or equivalent, with discontinuation =1 week). 5. Use of systemic immunostimulants (including but not limited to interferons or interleukin-2, including investigational immunostimulants) within 4 weeks before the first dose of study drug. 6. History of malignancies other than NSCLC within the past 5 years, except for adequately treated cervical carcinoma in situ, basal cell or squamous cell skin cancer, localized prostate cancer after radical surgery, ductal carcinoma in situ after radical surgery (hormonal therapy for non-metastatic prostate or breast cancer is allowed), and papillary thyroid cancer. 7. Vaccination with live attenuated vaccines within 4 weeks before the first dose or planned during the study. 8. Current participation in another interventional clinical study or receipt of other investigational drugs or devices within 4 weeks before the first dose. 9. Incomplete recovery from toxicity and/or complications of any prior interventions (i.e., 38.5°C during screening/before the first dose; 11. History of or suspected pneumonitis/interstitial lung disease or any pulmonary condition affecting pulmonary function tests. 12. Any active autoimmune disease or history of autoimmune disease; exceptions include type 1 diabetes controlled with insulin, hypothyroidism due to autoimmune thyroiditis requiring only hormone replacement therapy, childhood asthma fully resolved in adulthood without intervention, or vitiligo; patients requiring bronchodilators for medical intervention are excluded. 13. Congenital or acquired immunodeficiency, such as HIV infection, active hepatitis B or C, co-infection with hepatitis B and C, or alcoholic cirrhosis. 14. Evidence of active tuberculosis infection within 1 year before the first dose. 15. Grade II or higher myocardial ischemia or myocardial infarction, poorly controlled arrhythmias (including QTc interval >=450 ms for males or >= 470 ms for females), NYHA Class III-IV heart failure, or left ventricular ejection fraction (LVEF) <50% on echocardiography; myocardial infarction within 6 months before enrollment, NYHA Class II or higher heart failure, uncontrolled angina, uncontrolled severe ventricular arrhythmias, clinically significant pericardial disease, or ECG indicating acute ischemia or active conduction system abnormalities. 16. Severe hemorrhagic events or arterial/venous thrombotic events within 3 months before the first dose. 17. Known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation. 18. Known allergy, hypersensitivity, or into
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pathological complete response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-free survival;Safety;Overall survival; | — |
Countries
China
Contacts
Public ContactYang Fan
Peking University People's Hospital
Outcome results
None listed