NCT03972189Unknown2 期
Phase II, Open Label, Single Arm Study of the Efficacy and Safety of TQ-B3101 in Patients With ROS1-positive Non-Small Cell Lung Cancer (NSCLC)
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 入组人数
- 111
- 试验地点
- 22
- 主要终点
- Overall response rate (ORR)
研究概览
简要总结
To assess efficacy and safety of oral TQ-B3101 administered to patients with Advanced Non-Small Cell Lung Cancer (NSCLC) that confirmed ROS1 positive gene 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
- •1.18 years and older. 2.Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1；Life expectancy ≥ 3 months.
- •3.Understood and Signed an informed consent form. 4.Histologically or cytologically confirmed locally advanced or metastatic NSCLC .
- •5.Subjects in the screening period should provide a written report of ROS1 positive, or tumor histological specimens obtained at the time of diagnosis/post before enrollment are sent to the central laboratory to confirm ROS1 positive.
- •Had received no more than two chemotherapy regimens. 7.At least 1 measurable tumor lesion other than brain lesions within 28 days before first dose based on RECIST 1.
- •8.The main organs function are normally, the following criteria are met:
- •routine blood tests（no blood transfusion and blood products within 14 days）：hemoglobin（Hb）≥90g/L；absolute neutrophil count（ANC）≥1.5×109/L； platelets（PLT）≥100×109/L.
- •Blood biochemical examination: alanine transaminase（ALT）and aspartate aminotransferase（AST）≤2.5×upper limit of normal (ULN)（when the liver is invaded, ALT, and AST ≤5× upper limit of normal (ULN) ）； total bilirubin (TBIL)≤1.5×upper limit of normal (ULN)；Serum creatinine ≤ 1.5 × upper limit of normal (ULN); or creatinine clearance calculated ≥ 50ml / min (calculated according to Cockcroft-Gault formula);
- •left ventricular ejection fraction (LVEF) measured by the Cardiac echocardiography ≥ 50%.
- •9.Women must meet one of the following conditions:has undergone surgical sterilization;have been menopausal at least 1 year;have fertility, the following conditions must be met;Serum pregnancy test results were negative; throughout the study period to 6 months after the last dose, agreed to adopt an approved method of contraception (for example: oral contraception, injection contraception or implanted, barrier-effect Contraceptive methods, spermicides and condoms, or intrauterine devices).Men must meet one of the following conditions:has surgical sterilization;an approved method of contraception must be used throughout the study period and 6 months after the last dose.
排除标准
- •Has any known endothelial growth factor receptor (EGFR) positive mutation.
- •Prior therapy with crizotinib, anti-programmed cell death (PD)-1, anti-PD-L1 or any other ROS1 inhibitor.
- •Has multiple factors affecting oral medication, such as inability to swallow, post-gastrointestinal resection, chronic diarrhea and intestinal obstruction, etc.
- •Has diagnosed and/or treated additional malignancy within 5 years prior to randomization with the exception of cured carcinoma in situ of the cervix、 non-melanoma skin cancers and superficial bladder tumors.
- •Has a history of hypertensive crisis, hypertensive encephalopathy; or uncontrolled hypertension.
- •Has clinically significant, uncontrolled cardio-cerebral vascular disease.
- •Has major surgery and anti-tumor treatment before two weeks of treatment and participated in other drug clinical trials within four weeks.
- •Has known central nervous system metastasis and/or spinal cord compression, cancerous meningitis, and pia mater disease.
- •Has in screening period confirmed HCV positive, HIV positive, active syphilis positive, or HBsAg positive, HBV DNA titers >500 copies/ml and stable time <14 days after symptomatic treatment,or has a history of stem cells and organ transplantation.
- •Has history of psychotropic substance abuse that unable to abstain from or mental disorder.
- •According to the judgement of the researchers, there are other factors that may lead to the termination of the study.
研究组 & 干预措施
TQ-B3101
Experimental
TQ-B3101 300 mg given orally in fasting conditions, twice daily in 28-day cycle.
干预措施: TQ-B3101 (Drug)
结局指标
主要结局
Overall response rate (ORR)
时间窗: up to approximately 20 months
Percentage of Participants Achieving Complete Response (CR) and Partial Response (PR).
次要结局
- Disease control rate (DCR)(up to approximately 20 months)
- Duration of Response (DOR)(up to approximately 20 months)
- Overall survival (OS)(up to approximately 24 months)
- Progression-free survival (PFS)(up to approximately 20 months)
研究者
研究点 (22)
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