NCT05065398Unknown2 期
An Open Label， Multicenter Phase II Clinical Trial to Evaluate the Efficacy，Safety and Pharmacokinetics of HLX208 in Advanced Non-small Cell Lung Cancer Patients With BRAF V600 Mutation
Shanghai Henlius Biotech1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2021年11月15日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- ORR
研究概览
简要总结
Evaluate the efficacy，safety and pharmacokinetics of HLX208 in advanced non-small cell lung cancer patients with BRAF V600 mutation
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
- •Age>=18Y
- •Good Organ Function
- •Expected survival time ≥ 3 months
- •advanced BRAF V600 NSCLC that have been diagnosed histologically or cytology and have failed standard treatment or unable to receive, or refusing standard care.
- •Previous failure to standard treatment, or insuitability for standard treatment or refuse standard treatment.
- •ECOG score 0-2;
排除标准
- •Previous treatment with BRAF inhibitors or MEK inhibitors
- •Presence of EGFR mutations or ALK rearrangements (unless disease progression following prior treatment with tyrosine kinase inhibitors).
- •Symptomatic brain or meningeal metastases (unless the patient has been on > treatment for 1 months, has no evidence of progress on imaging within 4 weeks prior to initial administration, and tumor-related clinical symptoms are stable).
- •Current or former patients with interstitial lung disease;
- •Severe active infections requiring systemic anti-infective therapy
- •A history of other malignancies within two years, except for cured cervical carcinoma in situ, basal cell carcinoma of the skin, adenocarcinoma in situ of the lung, or tumors that do not require interventional treatment after radical surgery.
- •Other anti-tumor treatments, such as chemotherapy, targeted therapy, or radiation therapy (except palliative radiation therapy), may be given during the study period.
研究组 & 干预措施
HLX208
Experimental
干预措施: HLX208 (Drug)
结局指标
主要结局
ORR
时间窗: from first dose to the last patient was followed up for 6 month
The number of patients with CR or PR divided by the total number of treated
次要结局
- PFS(the time (month is regarded as the unit) from the first dose to the date of first documented progression or date of death from any cause, whichever came first,through treatment completion, an average of about 1 year)
- DOR(from the first occurrence of a documented CR or PR (whichever recorded earlier) to the time of first documented disease progression or death (whichever occurs first),through treatment completion, an average of about 1 year)
- OS(from the first dose to the time of death due to any cause, an average of about 2 year)
研究者
研究点 (1)
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