A Phase 2, Open-label, Single Arm Study to Investigate the Safety and Efficiency of Golidocitinib in Combination With Sintilimab in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) With PD-L1TPS ≥ 1%)
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 69
- 试验地点
- 1
- 主要终点
- Progression-free survival (PFS) (cohort2)
研究概览
简要总结
This is a phase 2 Study to investigate the safety, tolerability, and anti-tumor activity of golidocitinib in combination with sintilimab as the front-line treatment for patients with metastatic PD-L1 positive non-small cell lung cancer (NSCLC)
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
- •Be able to provide a signed and dated, written informed consent.
- •Adults aged ≥18 to 75 years.
- •ECOG performance status 0-
- •Predicted life expectancy ≥ 12 weeks
- •Histologically or cytologically confirmed non-small-cell lung cancer (NSCLC) , Stage IIIB/IIIC (not suitable for concomitant chemoradiotherapy) or Stage IV according to AJCC 8th
- •Without EGFR or ALK mutations.
- •Adequate bone marrow reserve and organ system functions.
- •Patients with stable and symptomatic brain metastasis (BM) can be enrolled.
- •Part A Dose escalation:
- •Patients must have relapsed after or been refractory/intolerant to ≥ 1 prior systemic therapy(ies) for NSCLC
- •Part B dose expansion:
- •At least one measurable lesion according to RECIST 1.
- •Previously systemic untreated for advanced disease.
- •PD-L1 TPS ≥ 50% (cohort 1), PD-L1 TPS 1-49% (cohort 2)
排除标准
- •Histopathology confirmed a mixture of NSCLC and small-cell lung cancer
- •Known active central nervous system (CNS) metastases and/or carcinomatous meningitis.
- •Prior malignancy within 5 years
- •History of organ transplantation or hematopoietic stem cell transplantation
- •Sever lung function decline or interstitial lung disease that has required oral or IV steroids
- •Active autoimmune disease requiring systemic therapy within 2 years
- •Immunodeficiency, or being treated with immunosuppressive therapy (including systemic glucocorticoid) within 7 days prior to the first dose of study treatment.
- •Active infections
- •Significant cardiac disorder
- •Other serious or uncontrolled systemic diseases assessed by the investigator.
- •Part A Dose escalation:
- •Prior systemic therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or stimulatory or synergistic T-cell receptor (CTLA-4、OX-40、CD137) within 4 weeks
- •Part B Dose Expansion:
- •Any prior systemic anti-tumor therapy
- •Prior systemic immunotherapy, including anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or stimulatory or synergistic T-cell receptor (CTLA-4、OX-40、CD137)
研究组 & 干预措施
Part B Dose expansion cohort 2 (PD-L1 TPS 1-49%)
Dose expansion cohort 2, Golidositinib plus Sintilimab following Sintilimab + chemotherapy
干预措施: Golidocitinib (Drug)
Part B Dose expansion cohort 1 (PD-L1 TPS ≥ 50%)
Dose expansion cohort 1, Golidositinib plus Sintilimab following Sintilimab
干预措施: Sintilimab (Drug)
Part A Dose escalation
Dose escalation part Golidocitinib in combination with sintilimab
干预措施: Golidocitinib (Drug)
Part A Dose escalation
Dose escalation part Golidocitinib in combination with sintilimab
干预措施: Sintilimab (Drug)
Part B Dose expansion cohort 1 (PD-L1 TPS ≥ 50%)
Dose expansion cohort 1, Golidositinib plus Sintilimab following Sintilimab
干预措施: Golidocitinib (Drug)
Part B Dose expansion cohort 2 (PD-L1 TPS 1-49%)
Dose expansion cohort 2, Golidositinib plus Sintilimab following Sintilimab + chemotherapy
干预措施: Sintilimab (Drug)
Part B Dose expansion cohort 2 (PD-L1 TPS 1-49%)
Dose expansion cohort 2, Golidositinib plus Sintilimab following Sintilimab + chemotherapy
干预措施: platinum doublet chemotherapy (Drug)
结局指标
主要结局
Progression-free survival (PFS) (cohort2)
时间窗: through study completion, an average of 1 year
Time from first administration of study drug to first documented disease progression or death per investigator assessment according to RECIST 1.1
Overall response rate (ORR) (cohort1)
时间窗: through study completion, an average of 1 year
Complete response (CR) or partial response (PR) per investigator assessment according to RECIST 1.1
次要结局
- Overall survival (OS)(through study completion, up to 36 months)
- Incidence of Adverse Events(through study completion, up to 36 months)
研究者
Jie Wang
Chief Physician
Cancer Institute and Hospital, Chinese Academy of Medical Sciences