A Phase Ib/II Clinical Trial to Evaluate the Anti-tumor Efficacy, Safety, Tolerability, and Pharmacokinetics of IN10018 Combined With Anti-PD-1/L1 Antibody and Chemotherapy as First-line Treatment in Extensive-stage Small Cell Lung Cancer
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 120
- 试验地点
- 3
- 主要终点
- To identify the Recommended phase II dose (RP2D) of IN10018 in combination with Tislelizumab, Carboplatin and Etoposide in first-line ES-SCLC.
研究概览
简要总结
This is a multicenter, open-label, Randomized, phase Ib/II clinical study to evaluate the anti-tumor efficacy, safety, tolerability, and PK of IN10018 in combination with anti-PD-1/L1 monoclonal antibody (Tislelizumab is proposed as the combination drug) and chemotherapy (platinum and etoposide) as the first-line treatment in Extensive-stage small cell lung cancer (ES-SCLC).
详细描述
This study consists of 2 parts: 1) Phase Ib-Dose Confirmation part: To assess the PK parameters, safety and recommended phase II dose (RP2D) of IN10018 in combination with anti-PD-1/L1 monoclonal antibody (Tislelizumab is proposed as the combination drug), platinum (carboplatin is proposed as the combination drug) and etoposide as the first-line treatment in ES-SCLC. 2) Phase II-Dose Expansion part: To assess the antitumor efficacy, safety and tolerability in the experimental group of IN10018 in combination with Tislelizumab, carboplatin and etoposide as compared to the control group of Tislelizumab in combination with carboplatin and etoposide as the first-line treatment in ES-SCLC.
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Experimental group
IN10018 in combination with Tislelizumab, carboplatin and etoposide as the first-line treatment in ES-SCLC.
干预措施: IN10018 (Drug)
Experimental group
IN10018 in combination with Tislelizumab, carboplatin and etoposide as the first-line treatment in ES-SCLC.
干预措施: Tislelizumab (Drug)
Experimental group
IN10018 in combination with Tislelizumab, carboplatin and etoposide as the first-line treatment in ES-SCLC.
干预措施: Carboplatin (Drug)
Experimental group
IN10018 in combination with Tislelizumab, carboplatin and etoposide as the first-line treatment in ES-SCLC.
干预措施: Etoposide (Drug)
Control group
Tislelizumab in combination with carboplatin and etoposide as the first-line treatment in ES-SCLC
干预措施: Tislelizumab (Drug)
Control group
Tislelizumab in combination with carboplatin and etoposide as the first-line treatment in ES-SCLC
干预措施: Carboplatin (Drug)
Control group
Tislelizumab in combination with carboplatin and etoposide as the first-line treatment in ES-SCLC
干预措施: Etoposide (Drug)
结局指标
主要结局
To identify the Recommended phase II dose (RP2D) of IN10018 in combination with Tislelizumab, Carboplatin and Etoposide in first-line ES-SCLC.
时间窗: Up to 3 years
Evaluate proportion of patients suffered with AEs defined as dose-limited toxicities (DLTs) per protocol; and RP2D will be determined per the incidence of AEs defined as DLTs.
Progress free survival (PFS) of IN10018 in combination with Tislelizumab, carboplatin and etoposide as compared to Tislelizumab in combination with carboplatin and etoposide in first-line ES-SCLC per BICR based on RECIST 1.1
时间窗: Up to 3 years
Defined as the time from randomization to first documentation of disease progression or to death due to any cause, whichever comes first.
次要结局
- Objective response rate (ORR) of IN10018 in combination with Tislelizumab, carboplatin and etoposide as compared to Tislelizumab in combination with carboplatin and etoposide in first-line ES-SCLC per BICR and investigator based on RECIST 1.1.(Up to 3 years)
- PK: AUC of IN10018 following single dose administration and at steady state(Up to 3 years)
- Duration of objective response (DOR) of IN10018 in combination with Tislelizumab, carboplatin and etoposide as compared to Tislelizumab in combination with carboplatin and etoposide in first-line ES-SCLC per BICR and investigator based on RECIST 1.1.(Up to 3 years)
- Number of patients with adverse event(Up to 3 years)
- PK: Cmax of IN10018 following single dose administration and at steady state(Up to 3 years)
- PK: Ctrough of IN10018 following single dose administration and at steady state(Up to 3 years)
- PK: Tmax of IN10018 following single dose administration and at steady state(Up to 3 years)
- PK: Vd/F of IN10018 following single dose administration and at steady state(Up to 3 years)
- PFS of IN10018 in combination with Tislelizumab, carboplatin and etoposide as compared to Tislelizumab in combination with carboplatin and etoposide in first-line ES-SCLC per investigator based on RECIST 1.1(Up to 3 years)
- Disease Control Rate (DCR) of IN10018 in combination with Tislelizumab, carboplatin and etoposide as compared to Tislelizumab in combination with carboplatin and etoposide in first-line ES-SCLC per BICR and investigator based on RECIST 1.1(Up to 3 years)
- PK: t1/2 of IN10018 following single dose administration and at steady state(Up to 3 years)
- PK: CL/F of IN10018 following single dose administration and at steady state(Up to 3 years)
- Overall survival (OS) of IN10018 in combination with Tislelizumab, carboplatin and etoposide as compared to Tislelizumab in combination with carboplatin and etoposide in first-line ES-SCLC.(Up to 3 years)