NCT04063462Unknown2 期
A Phase 2 Study of Pyrotinib in Patients With Non-Small Cell Lung Cancer (NSCLC), With at Least One Prior Systemic Treatment, Locally Advanced or Metastatic, With EGFR or ERBB2 Exon 20 Insertion Mutation (PEER20)
Tianjin Medical University Cancer Institute and Hospital1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2019年10月1日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Objective Response Rate
研究概览
简要总结
This is a Phase 2, open-label study to evaluate the efficacy and the safety/tolerability of pyrotinib in previously treated NSCLC patients with EGFR exon 20 insertion mutations or HER2 exon 20 insertion mutations. Patient has had at least one prior systemic treatment for locally advanced or metastatic NSCLC.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18-80years，ECOG PS：0-2，Life expectancy of more than 3 months，with measurable lesion ( RECIST1.1).
- •Histologically or cytologic confirmed EGFR or HER2 Exon 20 Insertion Mutation positive advanced Non-small cell lung cancer who failed prior therapies.
- •≥1 target lesion that has not received radiotherapy in the past 3 months and can be accurately measured in at least 1 direction；Previously received radiation therapy, but the radiotherapy area must be <25% of the bone marrow area, and radiation therapy must have closed for at least≥4 weeks at the time of enrollment.
- •Main organs function is normal.
- •Signed and dated informed consent.
排除标准
- •Patient has had previous treatment with Pyrotinib, Poziotinib or any other EGFR or HER2 exon 20 insertion mutation-selective tyrosine kinase inhibitor (TKI) prior to study participation. The currently approved TKIs (ie, erlotinib, gefitinib, afatinib, osimertinib) are not considered to be exon 20 insertion-selective and are permissible
- •Patients who planned to receive systemic anti-tumor therapy within 4 weeks prior to allocation or during the course of this study, including cytotoxic therapy, signal transduction inhibitors, immunotherapy (or receiving the Mitomycin C 6 weeks prior to medication). Extra-field radiotherapy (EF-RT) was performed 4 weeks prior to allocation or restricted radiotherapy for assessing tumor lesions within 2 weeks prior to allocation
- •With kinds of factors which affect oral medicine (e.g. failing to swallow, gastrointestinal tract getting resected, chronic diarrhea and ileus)
- •Subjects with uncontrolled hypokalemia and hypomagnesemia before study entry
- •History of allergic reactions attributed to compounds of similar chemical or biologic composition to Pyrotinib
- •History of immunodeficiency, including HIV-positive or other acquired, congenital immunodeficiency disease, or history of organ transplantation; active infection including hepatitis B (HBV DNA level ≥1000 copies /mL), hepatitis C and human immunodeficiency virus (HIV); Severe acute or chronic infections requiring systemic treatment
- •Subjects had any heart disease, including: (1) angina; (2) requiring medication or clinically significant arrhythmia; (3) myocardial infarction; (4) heart failure; (5) Any heart diseases judged by investigator as unsuitable to participate in the trial
- •Known history of neurological or psychiatric disease, including epilepsy or dementia
- •Has a history of malignant tumors. Except for patients with cutaneous basal cell carcinoma, superficial bladder cancer, cutaneous squamous cell carcinoma or orthotopic cervical cancer who have undergone curative treatment and have no disease recurrence within 5 years after the start of treatment
- •Respiratory syndrome (dyspnea≥CTC AE 2), severe pleural effusion, ascites, pericardial effusion
- •Abnormal blood coagulation (INR>1.5 or PT > ULN + 4s or APTT > 1.5 ULN), with bleeding tendency or receiving thrombolytic or anticoagulant therapy; Renal insufficiency: urinary protein ≥ ++, or 24-hour urine protein ≥ 1.0g
- •Patient has had other malignancies within the past 3 years, except for stable non-melanoma skin cancer, fully treated and stable early stage prostate cancer or carcinoma in situ of the cervix or breast without need of treatment
- •Patient is pregnant or breast-feeding
- •Judgment by the investigator that should not participate in the study if the patient is unlikely to comply with study procedures, restrictions and requirements
研究组 & 干预措施
Cohort 1
Experimental
Previously treated patients with EGFR exon 20 insertion mutant positive NSCLC
干预措施: Pyrotinib (Drug)
Cohort 2
Experimental
Previously treated patients with HER2 exon 20 insertion mutant positive NSCLC
干预措施: Pyrotinib (Drug)
结局指标
主要结局
Objective Response Rate
时间窗: To evaluate objective response rate 6-8 weeks after the initiation of pyrotinib
The proportion of subjects who achieve Complete Response (CR) and Partial Response (PR) by the best response from the first dose of pyrotinib to the end of study.
次要结局
- Duration of Response (DoR)(24 months)
- Progression Free Survival(24 months)
- Disease Control Rate (DCR)(24 months)
- OS（Overall Survival）(24 months)
- Safety and Tolerability(24 months)
研究者
研究点 (1)
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