A Phase II Clinical Study of Adabrelimab Combined With Carboplatin, Albumin-bound Paclitaxel, and Recaticimab in Perioperative Treatment of Resectable NSCLC
Current studies confirmed that the immune perioperative treatment with combination chemotherapy curative effect and safety of resectable NSCLC, but its short-term curative effect and long-term survival benefit remains to be further improved to explore the new way of immune combination therapy. Experimental study showed that the inhibition of PCSK9 could significantly increase in tumor cells of the immune response in mice, inhibit the PCSK9 enhanced anti-tumor immune response of mice can be further coordinate with immune checkpoint therapy, forming a lasting anti-tumor immune effect. There are no reports on the peri-operative treatment of immune combined with chemotherapy and PCSK-9 inhibitors in patients with resectable NSCLC. Based on the above, the aim of this study is to explore the efficacy and safety of Adebrelimab combined with recaticimab and chemotherapy in the perioperative treatment of patients with resectable NSCLC.
• 18-75 years old, male and female;
• ECOG PS 0-1;
• Histologically or cytologically confirmed operable stage II-III NSCLC (stages II, IIIA, and T3N2M0 IIIB) according to the UICC and AJCC 8th edition TNM staging system. Non-massive metastases (short diameter ≤2cm Lymph nodes) with expected complete resectable N2;
• With a measurable lesions (per RECIST 1.1 standard, tumor lesions on CT scan length to diameter 10 mm, or lymph node lesions on CT scans short diameter 15 mm or higher);
• Anti-tumor treatment (radiotherapy, chemotherapy, surgery, and targeted therapy) naive enrollment;
• Enough of lung function to go through R0 resection with a purpose of cure;
• Normal main organs function, should meet the following criteria: (1) the blood routine examination shall meet within 14 days (without blood transfusion, hematopoietic factor not used and unused drugs to correct) a. ANC≥1.8 x 109 / L; B. Hb≥100 g/L; C. PLT ≥ 125×109/L; (2) Biochemical examination must meet the following criteria: a. TBIL ≤ 1.5ULN; B. ALT、AST≤2.5 ULN; Serum creatinine sCr≤1.5ULN, endogenous creatinine clearance≥50ml/min (Cockcroft-Gault formula)