A Phase III, Randomized, Open-Label Study of SYS6010 in Combination With Anti-PD-(L)-1 Monoclonal Antibody Versus Anti-PD-(L)-1 Monoclonal Antibody as Adjuvant Therapy for Patients With Completely Resected Stage II-IIIB NSCLC Who Have No Actionable Genomic Alterations and Not Achieved a Major Pathological Response.
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 570
- 主要终点
- Disease-Free Survival (DFS) assessed by the independent review committee (IRC)
研究概览
简要总结
The purpose of the study is to compare the efficacy and safety of SYS6010 in combination with anti-PD-(L)-1 monoclonal antibody vs. anti-PD-(L)-1 monoclonal antibody as adjuvant therapy for patients with. with completely resected stage II-IIIB, actionable genomic alterations (AGAs) negative non-small cell lung cancer (NSCLC) who did not achieve a major pathological response (MPR).
详细描述
This is a randomized, open-label, multicenter, Phase III clinical study. Participants with completely resected stage II-IIIB, actionable genomic alterations (AGAs) negative non-small cell lung cancer (NSCLC) who did not achieve a major pathological response (MPR) will be enrolled and randomized in a 1:1 ratio to experimental (SYS6010 + Enlonstobart) or control (Investigator's Choice of anti-PD-(L)-1 Monoclonal Antibody Regimen) group. Random factors include disease stage (Stage II / IIIA vs. Stage IIIB), Pathological type (non-squamous cell carcinoma vs. squamous cell carcinoma), and lymph node status (positive vs. negative).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Able to understand and willingness to voluntarily provide written informed consent.
- •Age 18 to 75 years, males or females.
- •Histologically confirmed squamous or non-squamous NSCLC.
- •Ability to provide qualified tumor samples.
- •Without actionable genomic alterations (AGAs), which should be tested at a local or central laboratory.
- •Did not achieve a Major Pathological Response (MPR) as assessed by the Central Pathology Independent Review Committee (CPIRC).
- •The International Association for the Study of Lung Cancer (IASLC) V9 Stage II-IIIB NSCLC, after confirmed complete surgical resection with resection margins proved microscopically free of disease (R0).
排除标准
- •Participants with a condition requiring further surgical resection, in the investigator's opinion.
- •Participants with diagnosis of stage IIIB with N3, and stage IIIC, IVA, and IVB NSCLC.
- •Eligible only for incomplete resection.
- •Participants with synchronous primary lung cancer or multiple primary malignancies, or a mixed histology of SCLC and NSCLC.
- •History of hypersensitivity or contraindication to any active or inactive excipient of the study treatment.
- •Prior or planned neoadjuvant or adjuvant radiotherapy for the current malignancy.
- •NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
结局指标
主要结局
Disease-Free Survival (DFS) assessed by the independent review committee (IRC)
时间窗: Up to approximately 60 months
DFS was defined as the time from randomization to either the date of disease recurrence or death (whatever the cause) as assessed by IRC per RECIST 1.1 or death (whatever the cause). Recurrence of disease was defined as local regional recurrence or a distant (metastatic) recurrence, confirmed by imaging and/or pathology. A second primary NSCLC was also considered to be an event.
次要结局
- Overall Survival (OS)(Up to approximately 60 months)
- DFS assessed by investigators(Up to approximately 60 months)
- Incidence and severity of Adverse Events (AEs)(Approximately 15 months)
- EORTC QLQ-30 questionnaire(Approximately 13 months)
- Blood concentration of SYS6010 and Enlonstobart(Approximately 13 months)
- Anti-drug Antibodies (ADAs) and Neutralizing Antibodies (Nabs)(Approximately 13 months)