NCT06182761尚未招募2 期
Efficacy and Safety of Sunvozertinib With Anlotinib in EGFR-TKIs Resistant EGFR-sensitive Mutated Locally Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC): a Prospective, Single-arm, Phase II Trial
Shanghai Zhongshan Hospital0 个研究点目标入组 45 人开始时间: 2024年1月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 45
- 主要终点
- ORR
研究概览
简要总结
The study will evaluate the efficacy and safety of treatment with sunvozertinib in combination with Anlotinib in patients whose disease has progressed following first-line EGFR-TKIs treatment.
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
- •Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form and in this protocol.
- •Pathologically confirmed non-squamous NSCLC. Locally advanced or metastatic NSCLC
- •EGFR sensitive mutations confirmed by accredited local laboratories， including 19del、L858R and T790M。
- •Intolerant or refuses, or not suitable for systemic chemotherapy.
- •Progressed after EGFR-TKI targeted therapy or are intolerant to standard treatment; if carry T790M mutation, need to be treated with osimertinib or other third-generation EGFR-TKI.
- •World Health Organization performance status of 0 to 1
- •Life expectancy >12 weeks at Day
- •At least 1 lesion to be measured
- •Females must be using highly effective contraceptive measures, and must have a negative pregnancy test prior to start of dosing if of childbearing potential, or must have evidence of non-childbearing potential by fulfilling criteria at screening.
- •Male patients must be willing to use barrier contraception
排除标准
- •Any known RET rearrangement, BRAF V600E mutation, NTRK fusion, MET ex14 skip mutation, MET amplification (defined as tissue detection GCN ≥ 5 by NGS)
- •Any concurrent and/or other active malignancy within 2 years
- •Major surgery within 4 weeks of the first dose of IP
- •Any unresolved toxicities from prior therapy.
- •Past medical history of ILD (interstitial lung disease)/pneumonitis, drug-induced ILD/pneumonitis, radiation pneumonitis that required steroid treatment, or any evidence of clinically active ILD/pneumonitis
- •Any evidence of severe or uncontrolled systemic diseases.
- •Any of the following cardiac criteria:
- •i) Mean resting QTc >470 msec ii) Any clinically important abnormalities in rhythm, conduction, or morphology of resting electrocardiogram iii) Any factors that increase the risk of QTc prolongation or risk of arrhythmic events
- •Refractory nausea and vomiting, chronic gastrointestinal diseases, inability to swallow the formulated product, or previous significant bowel resection that would preclude adequate absorption of Sunvozertinib and Anlotinib
- •Severe allergies to Sunvozertinib and Anlotinib
研究组 & 干预措施
sunvozertinib in combination with Anlotinib
Experimental
干预措施: Sunvozertinib combination with Anlotinib (Drug)
结局指标
主要结局
ORR
时间窗: initiate from first dose until the date of confirmed response, assessed up to 24 weeks
Objective response rate (ORR) as assessed by the investigator according to RECIST 1.1 criteria.
次要结局
- AE(through study completion, an average of 1 year)
- PFS(initiate from first dose, every 6 weeks until PD or study close, an average of 1 year)
- OS(through study completion, an average of 1.5 years)
- DoR(an average of 1 year)
研究者
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