NCT02531737已完成2 期
Multicenter Phase II Trial of Nintedanib (Vargatef®) Plus Docetaxel in Second Line of Treatment in Patients With no Squamous Non Small Cell Lung Cancer Refractory to First Line Chemotherapy
University Hospital, Limoges9 个研究点 分布在 1 个国家目标入组 59 人开始时间: 2015年9月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 59
- 试验地点
- 9
- 主要终点
- median progression free survival
研究概览
简要总结
The purpose of this study is to determine whether nintedanib (vargatef®) combined with docetaxel are effective in second line of treatment in patients with no squamous non small cell lung cancer refractory to first line chemotherapy.
详细描述
59 Patients with histologically documented stage IV NSCLC no squamous, after failure of first line chemotherapy and refractory (progressive disease during first line chemotherapy), will be enroled to receive docetaxel :75 mg/m² IV day 1 every 3 weeks with nintedanib (vargatef®):200 mg X 2/day per os day2-day21.
Tumor response (according to RECIST) will be assessed via computed tomography or magnetic resonance imaging scan every 6 weeks (evaluation of PFS) following completion of chemotherapy.
Adverse events (AEs) were graded according to the National Cancer Institute Common Toxicity Criteria, version 4.0
Quality of life(EQ5-D ) will be assessed every 6 weeks during chemotherapy. Tolerability will be assessed at each visit based on Common Terminology Criteria for Adverse Events (CTCAE), v4.0 criteria.
Total study duration per patient: approximately 12 months .
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
- •Histologically confirmed non-squamous NSCLC,
- •Metastatic NSCLC of stage IV (according to American Joint Committee on Cancers) or recurrent NSCLC)
- •Patients without activating epidermal growth factor receptor (EGFR) mutation
- •Patients without anaplastic lymphoma kinase (ALK) rearrangement
- •Patients must have measurable lesion by RECIST 1.1
- •Refractory disease defined by documented progression during the first-line chemotherapy based on a platinum doublet and third-generation drug (four or less cycles) according to RECIST V.1.1
- •Age ≥18 years and < 75 years
- •Performance status (PS) 0-1
- •Life expectancy of more than 12 weeks.
- •No history of other malignancy within the last 5 years, except for adequately treated carcinoma in situ of the cervix or basal cell or spinocellular carcinoma of the skin.
- •Adequate organ function, evidenced by the following laboratory results within 3 weeks prior to randomization: Normal hepatic function: bilirubin < 1.5 x N, ALT (alanine transaminase) and AST (aspartate aminotransferase ) < 2.5 x N or <5 x N in case of liver metastasis
- •Normal renal function (calculated creatinine clearance ≥ 45 mL/min).
- •Normal Calcemia
- •Normal haematological function (polynuclear neutrophils > 1.5 G/l, platelets > 100 G/l).
- •Anticoagulation with a vitamin K antagonist and low-molecular-weight heparin (LMWH) is authorized.
- •Antiplatelet treatment (aspirin authorized if < 325 mg/d)
- •Treatment with dipyridamole, ticlopidine, clopidogrel is not authorized
- •Women of child bearing potential must use double effective contraception.
- •Men might be surgically sterile or accept to use an effective contraceptive procedure during and until 6 months after the treatment.
- •Written informed consent to participate in the study.
排除标准
- •Known hypersensitivity to the trial drugs (nintedanib (vargatef®), docetaxel), peanut, soya, to their excipients
- •Controlled disease after first line treatment
- •Contra indication to the use of the backbone treatment
- •Patients who were withdrawn from first line treatment due to toxicity without documented disease progression or who received placebo (in the context of a clinical trial) as prior treatment are not eligible.
- •Previous treatment with docetaxel
- •Small-cell lung cancer, bronchioloalveolar cancer, neuroendocrine cancer.
- •Previous therapy with vascular endothelial growth factor (VEGF) inhibitors except bevacizumab
- •Centrally located tumour with radiographic evidence of local invasion of local blood vessels
- •Radiographic evidence of cavitary or necrotic tumours at screening
- •Chemo-, hormone-, radio-(except for brain and extremities) or immunotherapy or therapy with monoclonal antibodies or small tyrosine kinase inhibitors within the past 4 weeks prior to treatment with the trial drug.
- •Toxicity non resolute due to prior treatment > grade I (except alopecia).
- •Radiotherapy (except extremities) within the past 3 months prior to baseline imaging
- •Persistence of clinically relevant therapy related toxicity from previous radiotherapy
- •Active brain metastases (e.g. stable for <4 weeks, no adequate previous treatment with radiotherapy, symptomatic, requiring treatment with anti-convulsants; dexamethasone therapy will be allowed if administered as stable dose for at least one month before inclusion).
- •Uncontrolled arterial hypertension.
- •Concurrent radiotherapy, except for palliative bone irradiation.
- •Other concurrent severe illnesses (congestive heart failure, unstable angina, significant arrhythmia or myocardial infarction less than 12 months before study entry).
- •Stroke less than 6 months before study entry.
- •Psychiatric or neurological disorders preventing the patient from understanding the nature of the trial
- •Grade >=1 peripheral neuropathy
- •Uncontrolled infection.
- •Caval syndrome
- •Other organic disorders preventing inclusion in the trial
- •Malabsorption syndrome
- •Pregnancy and breast-feeding
- •Surgery less than two months before study entry.
- •Follow-up not feasible.
- •Incarcerated and institutionalized
研究组 & 干预措施
traitment
Experimental
Patients will be treated to oral nintedanib (vargatef®) 400 mg/d on days 2 to 21 of a 3-week cycle including docetaxel 75 mg/m2 by intravenous infusion on day 1
干预措施: vargatef® (Drug)
traitment
Experimental
Patients will be treated to oral nintedanib (vargatef®) 400 mg/d on days 2 to 21 of a 3-week cycle including docetaxel 75 mg/m2 by intravenous infusion on day 1
干预措施: Docetaxel (Drug)
结局指标
主要结局
median progression free survival
时间窗: 12 weeks
次要结局
- Toxicity (NCIC-CTC version 4.0 criteria)(Every 3 weeks during treatment up to 12 months from inclusion)
- Quality of life (EQ5-D questionnaire)(every 6 weeks up to 12 months from inlcusion)
- median progression free survival(12 month)
- Response rate(12 month)
研究者
研究点 (9)
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