A Phase 2, Open-label, Multicenter Study to Assess the Efficacy and Safety of Vactosertib in Combination with Pembrolizumab As a First-line Treatment for Subjects with PD-L1 Positive Advanced Non-Small Cell Lung Cancer
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 11
- 试验地点
- 1
- 主要终点
- ORR per RECIST 1.1
研究概览
简要总结
This is Phase 2, open label, multi-center study to assess safety and efficacy of vactosertib in combination with pembrolizumab as 1st line treatment for subjects with advanced or metastatic, PD-L1 positive, non-small cell lung cancer (NSCLC) who have not previously received systemic therapy for advanced disease and in whom EGFR, ALK, BRAF, ROS1-directed therapy is not indicated.
详细描述
Approximately 55 NSCLC subjects with PD-L1 tumor proportion score (TPS) ≥ 1% are expected to be enrolled in this study. Subjects' TPS will be determined by PD-L1 IHC 22C3 pharmDx assay performed according to local laboratory regulations prior to study enrollment.
Subjects who received adjuvant or neoadjuvant therapy are permitted onto the study if the therapy was completed at least 12 months prior to the development of metastatic disease.
Eligible subjects will receive:
• Vactosertib 300 mg orally (PO) BID for 5 days with 2 days off period (5 days on/2days off) and pembrolizumab 200 mg IV on Day 1 of every 3-week cycle (Q3W).
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
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have a histologically- or cytologically-documented NSCLC advanced or stage IV lung cancer
- •Have confirmation that EGFR, ALK, BRAF, ROS1-directed therapy is not indicated
- •Have measurable disease based on RECIST 1.1
- •PD-L1 expression is ≥1% as determined by the PD-L1 IHC 22C3 pharmDx assay
- •Have a life expectancy of at least 3 months.
- •ECOG 0 or 1
- •Subjects must be able to swallow tablets and absorb vactosertib.
- •Have adequate organ function as indicated by the following laboratory values in
排除标准
- •Is currently participating in a study of an investigational agent
- •Has received prior systemic cytotoxic chemotherapy for metastatic disease/ antineoplastic biological therapy /Had major surgery / radiation therapy to the lung
- •Has received a live vaccine within 30 days prior to the first dose of study drug.
- •Is taking prohibited medications
- •Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy
- •Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis.
- •Had a severe hypersensitivity reaction to treatment with another mAb previously.
- •Has severe hypersensitivity to vactosertib and/or any of its excipients
研究组 & 干预措施
vactosertib+Pembrolizumab
Vactosertib (5days on and 2days off) Pembrolizumab 200mg Q3Weeks
干预措施: Vactosertib 300 mg BID and pembrolizumab 200 mg IV (Drug)
结局指标
主要结局
ORR per RECIST 1.1
时间窗: From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 3 years
ORR in PD-L1≥1% and PD-L1≥50% population per RECIST 1.1 by investigators
次要结局
未报告次要终点