An Open Label, Multicenter, Phase Ib Study Evaluating IBI310 (Anti-CTLA-4) in Combination With Sintilimab in Patients With Advanced, Recurrent or Metastatic Non-small-cell Lung Cancer (NSCLC)
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Objective Response Rate(ORR)
研究概览
简要总结
This is an open label, multicenter, phase Ib study evaluating IBI310 (anti-CTLA-4) in combination with Sintilimab in patients with advanced, recurrent or metastatic non-small-cell lung cancer (NSCLC)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •Had tumors other than NSCLC within the past 5 years.
- •Had allogeneic organ or stem cell transplantation.
- •The presence of uncontrolled life-threatening illness
- •Women of child-bearing potential who are pregnant or breastfeeding because of the potentially dangerous effects of the preparative chemotherapy on the fetus or infant.
- •Patients who have used large doses of glucocorticoids, anti-cancer monoclonal antibodies, and other immunosuppressive agents within 4 weeks.
- •HIV positive.
- •Patients with significantly lower heart, liver, lung, kidney and bone marrow function.
- •Severe, uncontrolled medical conditions and infections.
- •At the same time using other test drugs or in other clinical trials.
- •Refusal or inability to sign informed consent to participate in the trial.
- •Other treatment contraindications.
- •Emotional disturbance or mental illness, no civil capacity or limited capacity for civil conduct.
- •Hepatitis B surface antigen (HBsAg) positive and HBVDNA ≥1000cps/ml.
- •Patients with positive HCV antibody test results can only be included in the study when the polymerase chain reaction of HCV RNA is negative.
研究组 & 干预措施
IBI310 (anti-CTLA-4) 1mg/kg(Q3W until progressive disease)in combination with Sintilimab
The test group will be treated with IBI310 1mg/kg IV, Q3W+ Sintilimab 200 mg IV, Q3W until progressive disease,intolerable toxicity, start of a new antitumor treatment, withdrawal of informed consent, loss to follow-up, death or other situations requiring termination of treatment specified in the protocol, whichever occurs first.
干预措施: Sintilimab (Drug)
IBI310 (anti-CTLA-4) 1mg/kg(Q3W until progressive disease)in combination with Sintilimab
The test group will be treated with IBI310 1mg/kg IV, Q3W+ Sintilimab 200 mg IV, Q3W until progressive disease,intolerable toxicity, start of a new antitumor treatment, withdrawal of informed consent, loss to follow-up, death or other situations requiring termination of treatment specified in the protocol, whichever occurs first.
干预措施: IBI310 (Drug)
IBI310 (anti-CTLA-4) 1mg/kg(Q3W*4cycles)in combination with Sintilimab
The test group will be treated with IBI310 1mg/kg IV, Q3W+ Sintilimab 200 mg IV, Q3W*4cycles,and then Sintilimab 200 mg IV, Q3W single until progressive disease,intolerable toxicity, start of a new antitumor treatment, withdrawal of informed consent, loss to follow-up, death or other situations requiring termination of treatment specified in the protocol, whichever occurs first.
干预措施: Sintilimab (Drug)
IBI310 (anti-CTLA-4) 1mg/kg(Q3W*4cycles)in combination with Sintilimab
The test group will be treated with IBI310 1mg/kg IV, Q3W+ Sintilimab 200 mg IV, Q3W*4cycles,and then Sintilimab 200 mg IV, Q3W single until progressive disease,intolerable toxicity, start of a new antitumor treatment, withdrawal of informed consent, loss to follow-up, death or other situations requiring termination of treatment specified in the protocol, whichever occurs first.
干预措施: IBI310 (Drug)
IBI310 (anti-CTLA-4) 1mg/kg(Q6W)in combination with Sintilimab
The test group will be treated with IBI310 1mg/kg IV, Q6W+ Sintilimab 200 mg IV, Q3Wuntil progressive disease,intolerable toxicity, start of a new antitumor treatment, withdrawal of informed consent, loss to follow-up, death or other situations requiring termination of treatment specified in the protocol, whichever occurs first.
干预措施: Sintilimab (Drug)
IBI310 (anti-CTLA-4) 1mg/kg(Q6W)in combination with Sintilimab
The test group will be treated with IBI310 1mg/kg IV, Q6W+ Sintilimab 200 mg IV, Q3Wuntil progressive disease,intolerable toxicity, start of a new antitumor treatment, withdrawal of informed consent, loss to follow-up, death or other situations requiring termination of treatment specified in the protocol, whichever occurs first.
干预措施: IBI310 (Drug)
IBI310 (anti-CTLA-4) 0.5mg/kg in combination with Sintilimab
The test group will be treated with IBI310 0.5mg/kg IV, Q3W+ Sintilimab 200 mg IV, Q3W until progressive disease,intolerable toxicity, start of a new antitumor treatment, withdrawal of informed consent, loss to follow-up, death or other situations requiring termination of treatment specified in the protocol, whichever occurs first.
干预措施: Sintilimab (Drug)
IBI310 (anti-CTLA-4) 0.5mg/kg in combination with Sintilimab
The test group will be treated with IBI310 0.5mg/kg IV, Q3W+ Sintilimab 200 mg IV, Q3W until progressive disease,intolerable toxicity, start of a new antitumor treatment, withdrawal of informed consent, loss to follow-up, death or other situations requiring termination of treatment specified in the protocol, whichever occurs first.
干预措施: IBI310 (Drug)
结局指标
主要结局
Objective Response Rate(ORR)
时间窗: Up to 2 years
Investigator evaluated ORR per RECIST V1.1
Treatment Emergent Adverse Event (TEAE)
时间窗: Up to 2 years
Incidence and severity of treatment-emergent: which is evaluated according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE, v5.0) grade;
Severe Adverse Event (SAE)
时间窗: Up to 2 years
Incidence and severity of treatment-emergent: which is evaluated according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE, v5.0) grade;
次要结局
- HRQoL(Up to 2 years)
- DOR(Up to 2 years)
- Progression Free Survival (PFS)(Up to 2 years)
- Overall Survival (OS)(Up to 2 years)
- Disease Control Rate (DCR)(Up to 2 years)
- Time to Response (TTR)(Up to 2 years)