[Translation] A study evaluating tislelizumab monotherapy and various tislelizumab-containing immunotherapy combinations with or without chemotherapy in the neoadjuvant setting in Chinese patients with resectable stage II to IIIA non-small cell lung cancer. Phase 2, randomized, open-label, multicenter, umbrella study of treatment's preliminary efficacy, safety, and pharmacodynamics
有效性目的:基于盲态独立病理学审查(BIPR)结果评估接受试验用药物作为新辅助治疗的患者的主要病理学缓解(MPR)率,病理学完全缓解(pCR)率及其他相关生存相关的终点,包括:无事件生存期(EFS)、总生存期(OS)、无病生存期(DFS)和相应的里程碑终点。 安全性目的;评估试验用药物作为新辅助治疗的安全性和耐受性,评估接受试验用药物作为新辅助治疗的患者中手术可行性。 药效学目的:评估试验用药物作为新辅助治疗时肿瘤内、血液和引流淋巴结中的药效学、预后生物标志物,以及缓解或耐药相关的生物标志物,评估表征试验用药物的药代动力学,评估试验用蛋白治疗药物的个体免疫原性
[Translation] Validity purpose: To evaluate the major pathological response (MPR) rate, pathological complete response (pCR) rate and other relevant survival-related parameters in patients who received the investigational drug as neoadjuvant therapy based on the results of blinded independent pathology review (BIPR). Endpoints include: event-free survival (EFS), overall survival (OS), disease-free survival (DFS) and corresponding milestone endpoints. Safety Objectives; To assess the safety and tolerability of investigational agents as neoadjuvant therapy and to assess surgical feasibility in patients receiving investigational agents as neoadjuvant therapy. Pharmacodynamic purpose: To evaluate the pharmacodynamics and prognostic biomarkers in the tumor, blood and draining lymph nodes when the investigational drug is used as neoadjuvant therapy, as well as biomarkers related to response or resistance, and to evaluate the pharmacodynamics of the investigational drug. Metabokinetics to assess individual immunogenicity of investigational protein therapeutics