Non-Small Cell Lung Cancer
Conditions
Interventions
Trial Group:SBRT: 24 Gy in 3 fractions+Aidebelimab: 1200 mg, intravenous infusion (iv), Day 1 (D1), once every 3 weeks (Q3W)+Apatinib: 250 mg, oral administration (P.O), once daily (qd), with 3 weeks
Sponsors
Xiamen Hospital of Zhongshan Hospital Affiliated to Fudan Un
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Age between 18 and 75 years inclusive, regardless of gender; 2. ECOG PS score of 0–1; 3. Patients who have not received prior systemic therapy and who consent to undergo curative-intent surgical resection; patients deemed free of surgical contraindications by a thoracic surgeon; 4. Histologically or cytologically confirmed squamous or non-squamous non-small cell lung cancer (NSCLC), judged by the investigator to be eligible for curative-intent R0 surgical resection, at stage II, IIIA, or selectively IIIB (only T3N2M0); disease staging must be performed according to the 8th edition of the AJCC/UICC staging system for NSCLC; 5. Sufficient tumor tissue available for PD-L1 expression testing with PD-L1 >=1%; 6. At least one measurable lesion according to RECIST 1.1 criteria; 7. Expected survival of at least 12 weeks; 8. Adequate function of major organs (liver, kidney, hematologic system, etc.): (1) Hemoglobin >=90 g/L (without blood transfusion, hematopoietic factors, or pharmacological correction within 2 weeks prior to first dose); (2) Absolute neutrophil count (ANC) >=1.5×10^9/L; (3) Platelet count >=100×10^9/L; (4) Total bilirubin =60 mL/min; (7) In patients not receiving anticoagulation therapy, prothrombin time international normalized ratio (INR) <=1.5 and activated partial thromboplastin time (APTT) <=1.5 times ULN; 9. No distant metastases (including M1a, M1b, M1c); 10. Complete resection is anticipated; 11. Sufficient pulmonary function to tolerate surgical intervention; 12. Female subjects of childbearing potential must have a negative pregnancy test (serum or urine) within 3 days prior to starting study drug, and must agree to use a medically accepted highly effective contraceptive method (e.g., intrauterine device, hormonal contraception, or condoms) throughout the study period and for 90 days after the last dose of study drug; male subjects with childbearing potential female partners must agree to use effective contraception or have undergone surgical sterilization throughout the study period and for 90 days after the last dose of study drug; 13. The subject voluntarily participates in this clinical study and has signed the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Prior receipt of any anti-tumor therapy, including radiotherapy, chemotherapy, immunotherapy, or traditional Chinese medicine for tumor treatment (excluding curatively treated malignancies with no recurrence or metastasis for >=5 years); 2. NSCLC patients with non-squamous histology who are EGFR mutation-positive or ALK-positive; non-squamous patients must undergo EGFR gene testing and ALK gene or immunohistochemistry testing; 3. Patients with distant metastases (including M1a, M1b, M1c); 4. Active autoimmune disease or history of autoimmune disease (e.g., uveitis, colitis, hepatitis, hypophysitis, vasculitis, myocarditis, nephritis, hyperthyroidism, hypothyroidism [after hormone replacement therapy, inclusion is permitted], tuberculosis); patients with childhood asthma fully resolved and requiring no intervention in adulthood, or skin diseases not requiring systemic treatment (e.g., vitiligo, psoriasis, or alopecia) may be included; however, patients requiring bronchodilator therapy for medical management are excluded; 5. Exclusion of subjects with evidence of prior or current pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonitis, drug-induced pneumonia, radiologically confirmed active pneumonia, or severely impaired pulmonary function; 6. Use of systemic corticosteroids (>10 mg/day prednisone or equivalent) or other immunosuppressive agents within 2 weeks prior to first dose; in the absence of active autoimmune disease, inhaled or topical corticosteroids and adrenal hormone replacement therapy at doses =2.5 mL; 11. Hypertension poorly controlled despite antihypertensive medication (systolic blood pressure >=140 mmHg or diastolic blood pressure >=90 mmHg); or grade II or higher myocardial ischemia/infarction, poorly controlled arrhythmias (including QTc interval >=450 ms in males or >=470 ms in females); NYHA class III–IV heart failure; or left ventricular ejection fraction (LVEF) =++, or 24-hour urinary protein >=1 g, or severe hepatic or renal insufficiency; 14. Uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage; 15. Hypersensitivity to the study drug; 16. Concurrent HIV infection or active viral hepatitis; 17. Pregnant or lactating women; or subjects of childbearing potential unwilling or unable to use effective contraception; 18. Neurological or psychiatric disorders impairing compliance; 19. Other malignancies diagnosed within the past <=5 years,
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pathological Complete Response (pCR); | — |
Secondary
| Measure | Time frame |
|---|---|
| Major Pathological Response (MPR); R0 Resection Rate; Objective Response Rate (ORR) ;Disease Control Rate (DCR); Recurrence-Free Survival (RFS); Overall Survival (OS);Safety of Therapeutic Drugs;Surgical safety indicators (such as assessment of surgical complications, operative time, and length of hospital stay); | — |
Countries
China
Contacts
Public ContactFan Hong
Xiamen Hospital of Zhongshan Hospital Affiliated to Fudan University
Outcome results
None listed