NCT07175220招募中2 期
A Multicenter, Open Label Phase II Clinical Study on the Safety, Tolerability, and Efficacy of SHR2554 Tablets in Combination With Other Anti-tumor Treatments in Subjects With Locally Advanced or Metastatic Non-small Cell Lung Cancer
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- DLT
研究概览
简要总结
Evaluate the safety, tolerability, and objective response rate (ORR) of SHR2554 tablets in combination with other anti-tumor treatments in subjects with locally advanced or metastatic non-small cell lung cancer
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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 range of 18-75 years old (including both ends), gender not limited;
- •Patients with locally advanced unresectable or metastatic non-small cell lung cancer diagnosed by pathology
- •ECOG score is 0 or 1
- •Expected survival period ≥ 12 weeks
- •Has a good level of organ function
- •Patients voluntarily joined the study and signed informed consent
排除标准
- •Having difficulty swallowing or malabsorption syndrome or any other uncontrolled gastrointestinal disease (such as nausea, diarrhea, or vomiting), having undergone gastrectomy or gastric banding surgery, etc
- •Symptomatic or active central nervous system tumor metastasis
- •Previously or simultaneously suffering from other malignant tumors
- •Spinal cord compression that cannot be cured by surgery and/or radiotherapy
- •Accompanied by uncontrolled tumor related pain
- •Plan to receive any other anti-tumor treatment during this trial period
- •Receive other anti-tumor treatments within 4 weeks before the first medication
- •Having undergone major surgeries other than diagnosis or biopsy within 28 days prior to the first administration
- •Currently participating in other clinical studies or taking medication for the first time less than 4 weeks after the end of the previous clinical study
- •Moderate to severe pleural effusion with clinical symptoms
- •Individuals with active pulmonary tuberculosis infection within one year prior to the first use of medication
- •Subjects who have experienced severe infections within 30 days prior to their first medication use
- •Administer attenuated live vaccine within 30 days before the first use of medication.
- •History of immunodeficiency
- •Suffering from poorly controlled or severe cardiovascular and cerebrovascular diseases
- •History of interstitial pneumonia/non infectious pneumonia requiring hormone therapy in the past
- •AE caused by previous anti-tumor treatment has not recovered to CTCAE v5.0 level evaluation ≤ 1
- •Untreated active hepatitis
- •Female participants who are pregnant, breastfeeding, or planning to become pregnant during the study period.
- •There are other serious physical or mental illnesses or laboratory abnormalities present
研究组 & 干预措施
Queue A
Experimental
干预措施: SHR2554; SHR-A2102 (Drug)
Queue B
Experimental
干预措施: SHR2554; Adabelimumab (Drug)
Queue C
Experimental
干预措施: SHR2554; SHR-1701 (Drug)
结局指标
主要结局
DLT
时间窗: 21days after the first administration of each subject
AE
时间窗: from Day1 to 30 days after last dose
Incidence and severity of serious adverse events (SAE)
时间窗: from Day1 to 30 days after last dose
ORR
时间窗: from first dose to disease progression or death, whichever comes first, up to 3 years
次要结局
- Immunogenic indicators: anti-SHR-A2102 antibody (ADA)(through study completion, an average of 2 years)
- Duration of response (DoR)(from first dose to disease progression or death, whichever comes first, up to 3 years)
- disease control rate (DCR)(from first dose to disease progression or death, whichever comes first, up to 3 years)
- progression free survival (PFS)(from first dose to disease progression or death, whichever comes first, up to 3 years)
- overall survival (OS)(from first dose to disease progression or death, whichever comes first, up to 3 years)
研究者
研究点 (1)
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