Non-small cell lung cancer
Conditions
Interventions
Experimental Group:Primary lesion SBRT (24Gy/3Fx, d1-3) ? 7-day interval, adebrelimab combined with platinum-based chemotherapy (3-week regimen, 3 treatment cycles) ? Radical surgery 3 to 8 weeks afte
Sponsors
Nanjing Drum Tower hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: (1) Age: 18 - 75 years old, gender not restricted; (2) Confirmed non-small cell lung cancer by histopathology or cytology; (3) TNM stage II - III (N2a) according to the 9th edition of lung cancer staging; (4) Evaluated by a thoracic surgeon and confirmed to meet the requirements for radical resection; (5) No previous local or systemic treatment for primary lung cancer; (6) Negative for driver genes such as EGFR and ALK; (7) At least one measurable lesion according to RECIST 1.1 criteria; (8) ECOG PS 0 or 1; (9) Expected survival >= 3 months; (10) Organ function levels must meet the following requirements: ANC >= 1.5×10^9/L; PLT >= 90×10^9/L; Hb >= 90 g/L; TBIL = 50 mL/min (Cockcroft-Gault formula); LVEF >= 50%; Fridericia-corrected QT interval (QTcF) < 450 ms for men and < 470 ms for women; INR <= 1.5×ULN, ACTT <= 1.5×ULN. (11) The subject has signed the informed consent form and voluntarily joined this study.
Exclusion criteria
Exclusion criteria: (1) Subjects with hypersensitivity or high sensitivity to therapeutic drugs; (2) Subjects with autoimmune diseases; (3) Subjects with third-space fluid accumulation that cannot be controlled by drainage or other methods (such as large amounts of pleural effusion and ascites); (4) Subjects who have received steroid treatment for more than 50 days or require long-term steroid use; (5) Subjects with uncontrolled symptomatic brain metastases or mental disorders who cannot accurately express subjective symptoms; (6) Subjects who have had other malignant tumors within 5 years before enrollment, except for cervical carcinoma in situ or skin squamous or basal cell carcinoma that was treated with curative intent; (7) Pregnant or lactating women, and women of childbearing age who refuse to take contraceptive measures; (8) Subjects with severe heart disease or a history of it, including: documented history of congestive heart failure, high-risk uncontrolled arrhythmia, angina pectoris requiring drug treatment, clinically confirmed valvular heart disease, history of severe myocardial infarction, and refractory hypertension; (9) Subjects who have received allogeneic tissue or solid organ transplantation; (10) Subjects with severe concomitant diseases that, in the judgment of the investigator, pose a significant risk to the subject's safety or interfere with the subject's ability to complete the study (such as uncontrolled hypertension, diabetes, thyroid disease, etc.); (11) Other situations deemed unsuitable for inclusion in the study by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Complete pathological response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Main pathological response rate;Event-free survival;R0 resection rate;Safety; | — |
Countries
China
Contacts
Public ContactYang yang/Xie Jiaqi
Nanjing Drum Tower hospital
Outcome results
None listed