NCT04989322招募中2 期
A Phase 2 Open-label Single-arm Study to Evaluate the Combination of Pembrolizumab, Lenvatinib and Chemotherapy in Non-small Cell Lung Cancer (NSCLC) Harbouring Targetable Mutation and Failed Standard Tyrosine Kinase Inhibitors
Dr Joanne CHIU1 个研究点 分布在 1 个国家目标入组 46 人开始时间: 2021年10月5日最近更新:
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 46
- 试验地点
- 1
- 主要终点
- Overall response rate
研究概览
简要总结
Adding chemotherapy or anti-VEGF to immunotherapy is an emerging strategy to enhance the efficacy of immunotherapy in many cancers. This phase 2 study aims to explore the preliminary efficacy of combination pembrolizumab with lenvatinib and chemotherapy in NSCLC patients with sensitizing EGFR, ALK, or ROS1 genetic aberration refractory to standard targeted therapy.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically proven NSCLC
- •Unresectable or metastatic NSCLC, including squamous cell carcinoma, harboring sensitizing EGFR, ALK, or ROS1 genetic aberrations who have received standard of care targeted therapy and have progressed on treatment. Patients with known T790M mutation should have received osimertinib and failed.
- •Measurable disease per RECIST 1.1
- •ECOG performance status ≤ 1
- •Adequate organ function
- •Adequately controlled blood pressure
排除标准
- •Prior exposure to immunotherapy or chemotherapy
- •Active untreated brain metastasis and/or carcinomatous meningitis
- •Active, known or suspected autoimmune disease
- •History of (noninfectious) pneumonitis that required systemic steroids or current pneumonitis/interstitial lung disease
- •Condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalent) or other immunosuppressive medications
- •Baseline proteinuria ≥ 1 g/24 hrs
- •Electrolyte abnormalities that have not been corrected
- •Significant cardiovascular impairment
- •Gastrointestinal pathology that might affect the absorption of lenvatinib
- •Preexisting grade ≥ 3 gastrointestinal or non gastrointestinal fistula
- •Bleeding or thrombotic disorders or subjects at risk for severe hemorrhage
- •Radiographic evidence of intratumoral caviations, encasement, or invasion of a major blood vessel
- •Known history of tuberculosis
- •Active, acute, or chronic clinically significant infections requiring therapy, including hepatitis B, hepatitis C, and HIV
- •ECG with long QTc interval ≥ 470 ms
研究组 & 干预措施
Treatment
Experimental
干预措施: Pembrolizumab (Drug)
Treatment
Experimental
干预措施: Lenvatinib (Drug)
Treatment
Experimental
干预措施: Pemetrexed (Drug)
Treatment
Experimental
干预措施: Carboplatin (Drug)
结局指标
主要结局
Overall response rate
时间窗: 24 months
Proportion of patients who have a confirmed CR or PR per RECIST 1.1
次要结局
- The incidence, severity as graded by NCI CTCAE v5.0, seriousness and relationship to study medication of adverse events (AEs)(24 months)
- Overall survival(36 months)
- Progression-free survival(24 months)
研究者
Dr Joanne CHIU
Assistant Professor
The University of Hong Kong
研究点 (1)
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