A Randomized Controlled, Multi-center Phase III Clinical Trial of SSGJ-707 Versus Pembrolizumab as First-line Treatment for PD-L1-Positive Locally-Advanced or Metastatic Non-Small Cell Lung Cancer
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 420
- 试验地点
- 1
- 主要终点
- PFS assessed by IRRC per RECIST v1.1
研究概览
简要总结
This trial is a Phase III study. All patients are stage IIIB/C (unsuitable for radical therapy) or IV non-small cell lung cancer(NSCLC), Eastern Cooperative Oncology Group (ECOG) performance status 0-1. The purpose of this study is to evaluate the efficacy and safety of SSGJ-707 comparing Pembrolizumab in subjects with advanced NSCLC whose tumors have a programmed cell death-ligand 1 (PD-L1) Tumor Proportion Score (TPS) greater than or equal to 1%.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Willing to participate in the study voluntarily, agree to comply with and complete all study procedures, and sign the Informed Consent Form (ICF).
- •At least 18 years of age at the time of signing the ICF, regardless of gender.
- •Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 or
- •Life expectancy of at least 12 weeks.
- •Histologically or cytologically confirmed locally advanced (Stage IIIB/IIIC) or metastatic (Stage IV) non-small cell lung cancer (NSCLC).
- •No prior systemic anti-tumor treatment for locally advanced or metastatic NSCLC.
- •At least one measurable tumor lesion as a target lesion according to RECIST v1.1 criteria.
排除标准
- •Presence of small cell carcinoma components in histological pathology.
- •Presence of EGFR-sensitive mutations or ALK fusion-positive NSCLC.
- •Known BRAF V600E mutation, MET exon 14 skipping mutation, NTRK fusion, RET fusion, or ROS1 fusion-positive NSCLC.
- •Presence of brainstem, leptomeningeal, spinal cord metastasis or compression.
- •Unresolved toxicity from prior anti-tumor treatment, defined as toxicity not returning to NCI CTCAE Version 5.0 Grade 0 or
- •History of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation.
- •History of immunodeficiency; positive for HIV antibodies;
- •Known active tuberculosis (TB);
- •Known history of severe allergy to any component of the investigational drug, or history of severe allergic reactions to chimeric or humanized antibodies.
- •Pregnant or breastfeeding women.
- •The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
研究组 & 干预措施
SSGJ-707
Subjects receive SSGJ-707 monotherapy intravenously (IV), selected dose.
干预措施: SSGJ-707 (Drug)
Pembrolizumab
Subjects receive Pembrolizumab monotherapy intravenously (IV), 200mg q3w.
干预措施: Pembrolizumab (Drug)
结局指标
主要结局
PFS assessed by IRRC per RECIST v1.1
时间窗: Up to 2 approximately years
Progression-free survival (PFS) is defined as the time from the date of randomization till the first documentation of disease progression (per RECIST v1.1 criteria) assessed by the blinded IRRC or death due to any cause (whichever occurs first).
次要结局
- DCR assessed by IRRC per RECIST v1.1(Up to 2 approximately years)
- OS(Up to 2 approximately years)
- ORR assessed by IRRC per RECIST v1.1(Up to 2 approximately years)
- DoR assessed by IRRC per RECIST v1.1(Up to 2 approximately years)
- TTR assessed by IRRC per RECIST v1.1(Up to 2 approximately years)
- PFS assessed by investigator per RECIST v1.1(Up to 2 approximately years)
- ORR assessed by the investigator per RECIST v1.1(Up to 2 approximately years)
- DoR assessed by the investigator per RECIST v1.1(Up to 2 approximately years)
- DCR assessed by the investigator per RECIST v1.1(Up to 2 approximately years)
- TTR assessed by the investigator per RECIST v1.1(Up to 2 approximately years)
- AE(Up to 2 approximately years)
- ADA(Up to 2 approximately years)
- PD-L1 expression(Up to 2 approximately years)