Sotiburafusp alfa

主要目的：评价HB0025 联合化疗对比帕博利珠单抗联合化疗的有效性； 次要目的： 1、评价HB0025 联合化疗对比帕博利珠单抗联合化疗的有效性； 2、评价HB0025 联合化疗对比帕博利珠单抗联合化疗在治疗过程中的安全性和耐受性； 3、评价HB0025在晚期鳞状NSCLC患者中的药代动力学（PK）特征； 4、评价HB0025在晚期鳞状NSCLC患者中的免疫原性特征； 探索性目的： 1、评价相关生物标志物与疗效之间的相关性； 2、评价HB0025 联合化疗对比帕博利珠单抗联合化疗的健康相关生活质量（HRQoL）

This study is a randomized, controlled, double-blind, multicenter Phase III registration clinical trial, aiming to evaluate the efficacy and safety of HB0025 combined with chemotherapy (pemetrexed plus carboplatin/cisplatin) versus tislelizumab combined with chemotherapy (pemetrexed plus carboplatin/cisplatin) as a first-line treatment for unresectable locally advanced (Stage IIIB/IIIC) or metastatic (Stage IV) nonsquamous non-small cell lung cancer (NSCLC).
The study will take progression-free survival (PFS) assessed by Blinded Independent Central Review (BICR) as the primary endpoint, and plans to enroll approximately 500 subjects. After being eligible for screening, patients will be randomly assigned to the study groups at a ratio of 1:1 to receive either HB0025 combined with chemotherapy (experimental group) or tislelizumab combined with chemotherapy (control group). Both regimens will be administered once every 3 weeks (Q3W). After completing 4 cycles of treatment, patients will enter the maintenance therapy phase with HB0025 or tislelizumab plus pemetrexed (Q3W). The treatment will last until the investigator determines that there is no longer clinical benefit (based on comprehensive assessment of RECIST v1.1 imaging results and clinical symptoms), intolerable toxicity occurs, 35 cycles of study treatment are completed, or other treatment termination criteria specified in the protocol are met, whichever comes first.