EUCTR2015-000475-27-FR进行中（未招募）1 期
Multicenter phase II trial of Nintedanib plus docetaxel in second line of treatment in patients with no squamous non small cell lung cancer refractory to first line chemotherapy (REFRACT study) - REFRACT
CHU de Limoges0 个研究点目标入组 59 人开始时间: 2015年7月20日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 59
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Histologically confirmed non-squamous NSCLC,
- •Locally advanced and/or metastatic NSCLC of stage IV (according to American Joint Committee on Cancers) or recurrent NSCLC)
- •Patients without activating EGFR mutation
- •Patients without 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 (WHO, Appendix C).
- •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.
- •No ongoing treatment related toxicity due to prior treatment > grade I (except alopecia).
- •Adequate organ function, evidenced by the following laboratory results within 3 weeks prior to randomization: Normal hepatic function: bilirubin < 1.5 x N, ALAT and ASAT < 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 LMWH is authorized.
- •Antiplatelet treatment (aspirin authorized if < 325 mg/d)
- •Treatment with dipyridamole, ticlopidine, clopidogrel and/or cilostazol is not authorized
- •Women of child bearing potential must use effective contraception.
- •Men might be surgically sterile or accept to use an effective contraceptive procedure during and until 6 months after the treatment.
- •oWritten informed consent to participate in the study.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 25
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 34
排除标准
- •Known hypersensitivity to the trial drugs (nintedanib, docetaxel), to their excipients or to contrast media
- •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 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-, hormono-, 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.
- •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
研究者
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