A Phase II, Multicenter, Open-label Study to Evaluate the Efficacy and Safety of SKB518 in Patients With Lung Cancer
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 192
- 试验地点
- 17
- 主要终点
- AE
研究概览
简要总结
This is an open-label, multicenter, phase II study. The purpose of this study is to evaluate the safety, tolerability and preliminary anti-tumor activity of SKB518 in patients with lung cancer. Eligible subjects will receive SKB518 monotherapy, until radiographic disease progression, intolerable toxicity, discontinuation of study treatment required by the subject, or other protocol-specified treatment discontinuation criteria, whichever occurs first.
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
- •Age between 18 and 75 years old at the time of signing the informed consent form, applicable to both males and females.
- •Non-small cell lung cancer (NSCLC) or small cell lung cancer(SCLC) confirmed by histology or cytology.
- •At least one measurable tumor lesion per RECIST v1.
- •Performance status score of 0-1 according to the Eastern Cooperative Oncology Group (ECOG) scale.
- •Expected survival period ≥ 12 weeks.
- •The function of important organs meets the requirements of the protocol.
排除标准
- •Symptomatic or uncontrolled cardiovascular disease
- •History of noninfectious pneumonitis/interstitial lung disease (ILD) that required steroids or has current pneumonitis/ILD;
- •Subjects with the disease that requires systemic corticosteroid therapy (prednisolone or equivalent dose of similar drugs at a dose of >10 mg/d) or other immunosuppressive therapy within 14 days before the first dose.
- •Human immunodeficiency virus (HIV) positive or history of acquired immunodeficiency syndrome (AIDS); known active syphilis infection.
- •The Investigator considers other situations that will interfere with the evaluation of the study intervention or the safety of the subjects or the interpretation of the results of the study.
研究组 & 干预措施
2L+ SCLC or non-Squamous NSCLC
SKB518 monotherapy
干预措施: SKB518 (Drug)
2L SCLC
SKB518+Tislelizumab or Tislelizumab monotherapy
干预措施: SKB518 (Drug)
2L SCLC
SKB518+Tislelizumab or Tislelizumab monotherapy
干预措施: Tislelizumab (Drug)
1L ES-SCLC
SKB518+Tislelizumab+Carboplatin
干预措施: SKB518 (Drug)
1L ES-SCLC
SKB518+Tislelizumab+Carboplatin
干预措施: Tislelizumab (Drug)
1L ES-SCLC
SKB518+Tislelizumab+Carboplatin
干预措施: Carboplatin (Drug)
结局指标
主要结局
AE
时间窗: Up to 24 months
Incidence and severity of Adverse Events (AEs)
ORR in specific arms
时间窗: Up to 24 months
Objective Response Rate (ORR) assessed by the investigators per RECIST v1.1
AE
时间窗: Up to 24 months
Incidence and severity of Adverse Events (AEs)
PFS in specific arm
时间窗: Up to 24 months
Progression-Free Survival (PFS) assessed by the investigators per RECIST v1.1
次要结局
- OS(Up to 24 months)
- PFS in specific arms(Up to 24 months)
- OS(Up to 24 months)
- DOR in specific arms(Up to 24 months)
- Pharmacokinetics(Up to 24 months)
- Immunogenicity(Up to 24 months)