NCT05416775招募中1 期
An Open-label, Multicenter Phase Ib/II Clinical Study of SHR-8068 Combined With Adebrelimab and Platinum-based Chemotherapy in the Treatment of Advanced Non-small Cell Lung Cancer
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 168
- 试验地点
- 18
- 主要终点
- Objective Response Rate, determined using RECIST v1.1 criteria, defined as best overall response (complete or partial response) across all assessment time points;
研究概览
简要总结
To evaluate the tolerability and safety of SHR-8068 in combination with adebrelimab in subjects with advanced NSCLC To evaluate the efficacy of SHR-8068 in combination with adebrelimab and platinum-based chemotherapy in subjects with advanced NSCLC
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 18~75 years old, both male and female
- •Stage 1: pathologically diagnosed, incurable NSCLC subjects who have failed standard treatment
- •Stage 2: have a histologically or cytologically confirmed diagnosis of relapsed or metastatic NSCLC; have not received prior systemic treatment for their recurrent or metastatic NSCLC; PD-L1 TPS <50% as confirmed by central laboratory
- •At least one measurable lesion based on RECIST v1.1 criteria
- •ECOG PS score: 0-1 points
- •Expected survival period ≥ 3 months
- •Good levels of organ function
- •Patients voluntarily joined the study and signed informed consent
排除标准
- •Patients with EGFR activating mutation, positive ALK fusion gene or known ROS1 fusion gene
- •Untreated brain metastases; or associated with meningeal metastases, spinal cord compression, etc.
- •Uncontrolled pleural, pericardial, or ascites with clinical symptoms
- •Severe bone damage caused by tumor bone metastasis
- •Suffering from other malignant tumors in the past 3 years or at the same time
- •Presence of any active or known autoimmune disease
- •Systemic treatment with corticosteroids or other immunosuppressants within 2 weeks before the first dose
- •Have clinical symptoms or diseases of the heart that are not well controlled
- •Serious infection occurred within 1 month before the first dose
- •Past or current active interstitial lung disease requiring treatment, non-infectious pneumonia requiring glucocorticoid system treatment; current active pneumonia or pulmonary function test confirmed severe impairment of pulmonary function
- •With active pulmonary tuberculosis
- •Known positive history of human immunodeficiency virus test or acquired immunodeficiency syndrome, known active viral hepatitis
- •Known history of inflammatory bowel disease
- •Inoculated with live attenuated vaccine within 28 days before the first dose
- •Known allergic reaction to other monoclonal antibodies
- •Received >30 Gy of pulmonary radiotherapy within 6 months before the first dose; received major surgical treatment, systemic chemotherapy, immunotherapy or other clinical trial drugs within 4 weeks before the first dose; within 2 weeks before the first dose Received palliative radiotherapy; oral molecularly targeted drugs, discontinued to less than 5 half-lives before first dose; failure to recover from toxicity and/or complications of previous interventions to NCI-CTC AE ≤1 degree
- •According to the judgment of the researcher, there are other factors that may affect the results of the study or cause the study to be terminated halfway.
研究组 & 干预措施
SHR-8068 in combination with adebrelimab
Experimental
干预措施: SHR-8068；Adebrelimab (Drug)
SHR-8068 in combination with adebrelimab and platinum-based chemotherapy
Experimental
干预措施: SHR-8068；adebrelimab and platinum-based chemotherapy (Drug)
Adebrelimab in combination with platinum-based chemotherapy
Experimental
干预措施: Adebrelimab；platinum-based chemotherapy (Drug)
结局指标
主要结局
Objective Response Rate, determined using RECIST v1.1 criteria, defined as best overall response (complete or partial response) across all assessment time points;
时间窗: up to 2 years
Dose limiting toxicity
时间窗: The observation period is 21 days after the first dose
次要结局
- Progression-Free-Survival assessed by investigator(up to 2 years)
- Disease Control Rate, determined using RECIST v1.1 criteria(up to 2 years)
研究者
研究点 (18)
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