NCT06434103尚未招募1 期
An Open, Multicenter Phase I/II Trial of SHR-A1921 in Combination With Adebrelimab and SHR-8068 With or Without Carboplatin in the Treatment of Advanced NSCLC
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 124
- 主要终点
- DLT
研究概览
简要总结
A trial to evaluate the tolerability and efficacy of SHR-A1921 in combination with adbelizumab and SHR-8068 with or without carboplatin in patients with advanced non-small cell lung cancer
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Volunteer to join the clinical study, and sign the informed consent, compliance is good, can cooperate with follow-up;
- •Aged 18-75 at the time of signing the informed consent;
- •Histologically or cytologically confirmed patients with locally advanced or metastatic non-cellular lung cancer who are not eligible for surgical resection or radical concurrent chemoradiotherapy;
- •At least one measurable lesion consistent with RECIST v1.1;
- •ECOG PS score: 0-1;
- •The organ function level is good;
排除标准
- •Untreated (radiation or surgery) central nervous system metastasis, or accompanied by meningeal metastasis, spinal cord compression, etc.;
- •Uncontrolled pleural effusion, pericardial effusion, or peritoneal effusion with clinical symptoms;
- •Previous or co-existing malignant neoplasms;
- •The presence of any active or known autoimmune disease;
- •Have clinical symptoms or diseases of the heart that are not well controlled;
- •People with past or current interstitial pneumonia/interstitial lung disease;
- •Known allergic reactions to any component of SHR-A1921, Adebrelimab, or severe allergic reactions to other monoclonal antibodies;
- •Have previously received topoisomerase I inhibitors (including but not limited to irinotecan, Topotecan), TROP-2ADC, or ADC drugs containing topoisomerase I inhibitors; Previously received anti-PD-1 /PD-L1 antibody or anti-CTLA-4 antibody treatment;
研究组 & 干预措施
SHR-A1921 combined with Adebrelimab and SHR-8068 with or without carboplatin
Experimental
干预措施: SHR-A1921；Adebrelimab；SHR-8068；carboplatin (Drug)
结局指标
主要结局
DLT
时间窗: 21 days after the first dose
ORR based on RECIST v1.1 assessment.
时间窗: All enrolled subjects were evaluated every 6 or 9 weeks starting with the first dose, up to 2 years
次要结局
- Adverse event(All informed subjects signed informed consent from the beginning to the end of the safety follow-up period， up to 2 years)
- DCR based on RECIST v1.1 assessment(All enrolled subjects were evaluated every 6 or 9 weeks starting with the first dose, up to 2 years)
研究者
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