[Translation] A randomized, open-label, phase III study comparing gosartumumab with physician's choice of treatment in subjects with endometrial cancer who have received prior platinum-based chemotherapy and anti-PD-1/PD-L1 immunotherapy
主要目的:
1. 比较SG 与TPC 对BICR 评估的PFS 的影响;
2. 比较SG 与TPC 对OS的影响 关键次要目的:
1. 比较SG 与TPC 对BICR 评估的ORR 的影响;
2. 比较SG 与TPC 对躯体功能的影响 次要目的:
1. 比较SG 与TPC 对下列各项指标的影响: 研究者评估的PFS 研究者评估的ORR BICR 和研究者评估的DOR BICR 和研究者评估的CBR
2. 评价SG 相比TPC 的安全性和耐受性
3. 比较SG 与TPC 对GHS/QoL 产生的影响 探索性目的:
1. 评估肿瘤的滋养层细胞表面抗原2(Trop-2)表达状态,作为SG疗效的潜在预测性生物标记物
2. 评估肿瘤MMR/MSI 状态和临床缓解或治疗耐药之间的关系
3. 探索可预测临床缓解或治疗耐药的血液和肿瘤生物标志物
4. 表征SG 的药代动力学(PK)和免疫原性
5. 进一步表征健康相关QoL
[Translation] Primary objectives:
1. Compare the effects of SG and TPC on PFS assessed by BICR;
2. Compare the effects of SG and TPC on OS Key secondary objectives:
1. Compare the effects of SG and TPC on ORR assessed by BICR;
2. Compare the effects of SG and TPC on physical function Secondary objectives:
1. Compare the effects of SG and TPC on the following indicators: PFS assessed by investigators ORR assessed by investigators BICR and DOR assessed by investigators BICR and CBR assessed by investigators
2. Evaluate the safety and tolerability of SG compared with TPC
3. Compare the effects of SG and TPC on GHS/QoL Exploratory objectives:
1. Evaluate the expression status of trophoblast cell surface antigen 2 (Trop-2) in tumors as a potential predictive biomarker for the efficacy of SG
2. Evaluate the relationship between tumor MMR/MSI status and clinical remission or treatment resistance
3. Explore blood and tumor biomarkers that can predict clinical response or treatment resistance
4. Characterize the pharmacokinetics (PK) and immunogenicity of SG
5. Further characterize health-related QoL