NCT03693547已完成2 期
Open, Multicenter, Monotherapy, Phase II Clinical Study of Utidelone Injection in Patients With Advanced Non-small Cell Lung Cancer After Failure or Intolerability to Second-line Standard Treatment
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 26
- 试验地点
- 4
- 主要终点
- Tumor response to utidelone treatment
研究概览
简要总结
To assess the effectiveness and safety of utidelone injection in patients with advanced or metastatic NSCLC as a phase II trial
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically or cytologically confirmed non-small cell lung cancer
- •NSCLC patients who are not suitable for surgery or radical radiotherapy or chemotherapy, or who have failed to or are intolerable for standard treatment in local advanced or metastatic NSCLC;
- •NSCLC patients failed or intolerable to previous standard second-line treatment (including platinum chemotherapy or targeted therapy);
- •Patients who did not receive chemotherapy, radiotherapy, surgical therapy, molecularly targeted drug therapy, or immunotherapy 4 weeks prior to enrollment;
- •Age 18 -70 years old, ECOG performance status of 0-1; Life expectancy of 3 months or more;
- •Patients must have measurable disease, defined as at least one target lesion that can be accurately measured by imaging techniques in at least one dimension as ≥20 mm with conventional computed tomography (CT), ≥10 mm with spiral CT scan (≥15mm for lymph node) within 3 weeks before enrolment;
- •Patients with no brain metastases or with brain metastases but are stable for more than 4 weeks after treatment;
- •Peripheral neuropathy (PN) <grade 2 on the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 within 4 weeks before enrolment;
- •Patients must have normal haematology as defined below: HGB ≥9 g/L, absolute neutrophil count ≥1.5×109/L, platelets ≥80×109/L, bilirubin ≤1.5× the upper limit of normal (ULN) (patients with liver metastasis ≤3xULN), aspartate transaminase (AST)/ alanine transaminase (ALT) ≤2.5 ×ULN (patients with liver metastasis ≤5xULN), and creatinine clearance ≥45 mL/min;
- •Patients with no major organ dysfunctions and heart disease;
- •Patients who give written informed consent with good compliance.
排除标准
- •Patients who are pregnant or breast feeding;
- •Patients with active tuberculosis
- •Patients with high possibility of interstitial lung disease ;
- •Patients with comorbidities, such as carcinomatous meningitis, central nervous system (CNS) metastasis, other active malignancies requiring simultaneous treatment, but not including cervical cancer in situ or basal cell carcinoma of the skin, severe disorders of the heart, lung, liver, or kidneys, severe hypertension, uncontrolled diabetes, severe gastrointestinal ulceration, active infections in need of antibiotics, or with incontrollable psychiatric history;
- •patients with HIV, untreated active hepatitis；
- •Patients with poor compliance;
- •Patients not fitted for this study determined by the investigators.
研究组 & 干预措施
utidelone
Experimental
Utidelone Injection: 30 mg/m2/day, IV on day 1-day 5 of each 21 day cycle, administered to enrolled patients with advanced NSCLC
干预措施: utidelone injection (Drug)
结局指标
主要结局
Tumor response to utidelone treatment
时间窗: 6 months from first study treatment
Reflected by percentage of tumor size reduction or regression, assessed by imaging techniques and expressed as Objective Response Rate (ORR）ORR is defined as the proportion of patients with a best overall response of Complete Response (CR) or Partial Response (PR) according to RECIST. 1.1.
次要结局
- Progression free survival (PFS)(1 year from first study treatment)
- Overall survival (OS)(2 year from enrolment)
- Incidence of treatment-emergent adverse events based the Common Terminology Criteria for Adverse Events (CTCAE) version 4·03(1 year from first study treatment)
研究者
研究点 (4)
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