A Prospective, Open-label, Single Arm, Multi-center, Phase II Exploratory Trial to Evaluate the Efficacy and Safety of NOV120101 (Poziotinib) as the First-line Treatment Medication in Patients With Harboring EGFR Mutations
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 22
- 试验地点
- 6
- 主要终点
- Objective response rate (ORR)
研究概览
简要总结
The purpose of this open-label, single-arm, multi-center phase II trial is to evaluate the efficacy and safety of novel pan-HER inhibitor, NOV120101 (Poziotinib), as a first-line monotherapeutic agent in patients with lung adenocarcinoma harboring EGFR mutation.
详细描述
EGFR TKIs are known as more effective and less toxic medications against EGFR mutated tumors. However, newly acquired resistance to these inhibitors is the inevitable obstacle in continuous treatment with them. To overcome this problem, many new class of TKIs including NOV120101 (Poziotinib) are developing these days. To evaluate the efficacy of NOV120101 (Poziotinib) as a first-line monotherapeutic medication, chemotherapy-naïve patients will participate in this study. Subjects will receive NOV120101 (Poziotinib) 12 mg PO once daily until disease progression or unacceptable toxicity development. Objective response rate (ORR) will be analyzed as the primary endpoint in this trial. Secondary endpoints including PFS rate at 12 months, DCR, PFS, and OS will also be analyzed.
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
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female patients aged 20 years or older
- •Pathologically confirmed stage IIIB (unresectable) or IV lung adenocarcinoma
- •Documented EGFR mutation (e.g., exon 19 deletion, exon 21 L858R, etc.) with tumor tissue
- •Patients who have 1 or more measurable lesions according to RECIST version 1.1
- •ECOG performance status 2 or less
- •Life expectancy of 12 weeks or more
- •Patients who have adequate hematological, hepatic and renal functions; WBC 4,000 or more per mm3, platelet 100,000 or more per mm3, serum creatinine 1.5 times or less upper limit of normal, AST and ALT 2.5 times or less upper limit of normal, total bilirubin 1.5 times or less upper limit of normal
- •Patients who give written informed consent voluntarily
排除标准
- •Prior systemic chemotherapy, immunotherapy or biological therapy for stage IIIB or IV adenocarcinoma (However, neo or adjuvant chemo, chemoradio or radiotherapy is permitted if at least 6 months has elapsed prior to disease progression)
- •Prior treatment with small molecules or antibodies targeting EGFR
- •Patients who received major surgery within 4 weeks before study drug administration
- •Symptomatic CNS metastases (patients with radiologically and neurologically stable metastases and being off corticosteroids for at least 2 weeks are able to participate in this trial.)
- •History of other malignancies except effectively treated non-melanoma skin cancers, carcinoma in situ of the cervix, ductal carcinoma in situ or effectively treated malignancy that has been in remission for 3 years or more and considered to be cured by investigator's judgment
- •Known preexisting interstitial lung disease (ILD)
- •NYHA class III or IV heart failure, uncontrolled hypertension, unstable angina or myocardial infarction within 6 months, poorly controlled arrhythmia or other clinically significant cardiovascular abnormalities at investigator's discretion
- •Patients whose left ventricle ejection fraction (LVEF) is below the institutional lower limit of normal (if no lower limit of normal is defined in the site, the lower limit is 50 percent)
- •Patients with known active hepatitis B, HIV infection, or other uncontrolled infectious disease
- •Clinically significant or recent acute gastrointestinal disorders with diarrhea as a major symptom (e.g., Crohn's disease, malabsorption disorders, CTCAE grade 2 diarrhea or more due to any etiology)
- •Patients who cannot receive IP by mouth and be diagnosed with clinically significant gastrointestinal disorders which can prevent administration, transit or absorption of the study drug
- •Pregnancy or breast feeding
- •Women of childbearing potential (WOCBP) or men who are unwilling to use adequate contraception or be abstinent during the trial and for at least 2 months after the end of treatment
- •Patients who received other investigational products except gefitinib and erlotinib within 4 weeks before participation
- •Patients who cannot participate in this trial by investigator's judgment
研究组 & 干预措施
NOV120101 (Poziotinib)
Single arm study with NOV120101(poziotinib)12mg PO daily administration
干预措施: NOV120101 (Poziotinib) (Drug)
结局指标
主要结局
Objective response rate (ORR)
时间窗: about 3 years
the proportion of patients with complete response (CR) and/or partial response (PR)
次要结局
- Progression free survival (PFS)(3 years)
- Overall survival (OS)(3 years)
- Change of quality of life (QoL) measured by EQ-5D questionnaire(3 years)
- Progression free survival (PFS) rate at 12 months(12 months after enrollment of the last subject)
- Disease control rate (DCR)(3 years)