A Randomized, Open-Label, Multicenter Phase III Clinical Study of SKB264 in Combination With Pembrolizumab Versus Pembrolizumab as First-Line Treatment for PD-L1 Positive Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 406
- 试验地点
- 64
- 主要终点
- Progression Free Survival (PFS) assessed by Blinded Independent Central Review (BICR)
研究概览
简要总结
The aim of the study is to evaluate the efficacy and safety of SKB264 in combination with pembrolizumab as firstline treatment for patients with PD-L1-positive locally advanced or metastatic non-small cell lung cancer (NSCLC).
详细描述
This is a randomized, open-label, multicenter, Phase 3 study to evaluate the efficacy and safety of SKB264 in combination with pembrolizumab versus pembrolizumab as firstline treatment for PD-L1 positive patients with locally advanced or metastatic non-small cell lung cancer.
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
- •Histologically or cytologically confirmed NSCLC that is locally advanced (Stage ⅢB/ⅢC) or metastatic (Stage IV) NSCLC that is not amenable to radical surgery and/or radical radiotherapy regardless of concurrent chemotherapy.
- •No prior systemic anti-cancer therapy for locally advanced or metastatic disease.
- •Participants whose tumours are PD-L1 TPS ≥ 1%.
- •At least one measurable lesion per RECIST v1.
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 with no worsening within 7 days prior to randomization.
- •A life expectancy of at least 12 weeks.
- •Adequate organ and bone marrow function.
排除标准
- •Active second malignancy.
- •Uncontrolled or clinical significant cardiovascular disease.
- •History of noninfectious pneumonitis/interstitial lung disease (ILD) that required steroids or has current pneumonitis/ILD.
- •Active infection requiring systemic therapy within 2 weeks of randomization.
- •Active hepatitis B or hepatitis C virus infection.
- •Human immunodeficiency virus (HIV) positive or history of acquired immunodeficiency syndrome (AIDS); known active syphilis infection.
- •Known allergy to SKB264 or pembrolizumab or any of its components.
- •Prior treatment with any of the following (including in the context of adjuvant, neoadjuvant therapy):
- •Immune checkpoint inhibitors (e.g., anti-PD-1/L1 antibody, anti-CTLA-4 antibody, etc.), checkpoint agonists (e.g., ICOS, CD40, CD137, GITR, OX40 antibody, etc.), any treatment targeting the immune mechanism of tumors such as immune cell therapy;
- •Therapy targeting TROP
- •Any drug therapy that targets topoisomerase I, including antibody-drug conjugates (ADCs).
- •Major surgery within 4 weeks prior to randomization or expected major surgery during the study.
- •Pregnant or lactating women.
研究组 & 干预措施
Pembrolizumab
Participants will receive Pembrolizumab on Day 1 of each 6-week cycle.
干预措施: Pembrolizumab (Drug)
SKB264+Pembrolizumab
Participants will receive SKB264 on Day 1、Day 15 and Day 29 of each 6-week cycle,Pembrolizumab on Day1 of each 6-week cycle.
干预措施: SKB264 (Drug)
SKB264+Pembrolizumab
Participants will receive SKB264 on Day 1、Day 15 and Day 29 of each 6-week cycle,Pembrolizumab on Day1 of each 6-week cycle.
干预措施: Pembrolizumab (Drug)
结局指标
主要结局
Progression Free Survival (PFS) assessed by Blinded Independent Central Review (BICR)
时间窗: Randomization up to approximately 22months
PFS is defined as the time from randomization to the first documented disease progression per RECIST 1.1 based on BICR or death due to any cause, whichever occurs first.
次要结局
- Progression-Free Survival (PFS) assessed by Investigator(Randomization up to approximately 22months)
- Duration of Response (DoR)(Randomization up to approximately 22months)
- Overall Survival (OS)(Randomization up to approximately 40 months)
- Objective Response Rate (ORR)(Randomization up to approximately 22months)
- Disease control rate (DCR)(Randomization up to approximately 22months)
- Time to Response (TTR)(Randomization up to approximately 22months)
- Health-Related Quality of Life Assessment(Randomization up to approximately 22months)
- AEs and SAEs(All AEs should be observed and recorded from the first dose until 30 days after the last dose. SAEs were observed and recorded until 90 days after the last dose of pembrolizumab or 30 days after the last dose of SKB264,whichever occurred later.)
- PK(Randomization up to approximately 22months)
- Immunogenicity(Randomization up to approximately 22months)
- Biomarkers(Tumor tissue samples should be provided for TROP2 testing after subjects are eligible for screening.)