EUCTR2014-003859-61-GR进行中（未招募）1 期
Randomized Phase II study comparing single agent oral vinorelbine administered with two different schedules in patients with Advanced Non Small Cell Lung Cancer unfit for a platinum-based chemotherapy - TEMPO LUNG 01
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 166
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
- •-The patient must give written (personally signed and dated) informed consent before completing any study-related procedure.
- •-Patients > or equal to 18 years.
- •-Histologically or cytologically confirmed NSCLC.
- •-ECOG Performance Status of 0-1 or 2,
- •-Advanced disease: stage IIIB (with supra-clavicular nodal metastases), stage IV or relapsing (locally or distant) after a local treatment. Patients not suitable for loco-regional treatment.
- •-Patients unfit for receiving a platinum-based chemotherapy based on at least one or more of the following criteria:
- •Previous adjuvant platinum-based chemotherapy for resected NSCLC;
- •Creatinine Clearance < 60 ml/min;
- •Heart Failure NYHA class II-III;
- •Hearing Loss > Grade 2;
- •Medical condition impairing platinum-based chemotherapy according to physician’s opinion.
- •-Life expectancy more than 12 weeks.
- •-Adequate bone marrow, hepatic and renal functions:
- •Neutrophils > or equal 2.0 x 109/l, Platelets > or equal 100 x 109/l, Haemoglobin > or equal 10.0 g/dL;
- •Total bilirubin < or equal 1.5 x ULN (Upper Limit of Normal), Transaminases (ALT, AST) < 2.5 x ULN, Alkaline Phosphatases < 5 x ULN;
- •Calculated creatinine clearance > or equal 30 ml/min (Cockcroft and Gault formula),
- •-Previous Therapy:
- •Chemotherapy: no previous chemotherapy for advanced NSCLC. Patients may have been treated with adjuvant chemotherapy for completely resected NSCLC;
- •Surgery: patients may have had previous surgery for NSCLC;
- •Radiation therapy: patient may have received prior radiotherapy but not on the site used to assess response. A minimum of 2 weeks interval must have elapsed;
- •Targeted therapy: patient with EGFR or ALK mutation may have had previous targeted therapy or immunotherapy.
- •-Presence of at least one measurable lesion which has not been previously irradiated (RECIST Version 1.1). Measurable lesions (measured in at least one dimension, longest diameter to be recorded) as > or equal 20 mm with conventional techniques or as > or equal 10 mm with CT scan. Physical examination and ultrasound will not be considered as objective tumour assessments.
- •-Absence of any psychological, familial, sociological or geographical conditions potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be assessed with the patient before randomisation in the trial.
- •-Women of childbearing potential must be using a medically accepted method of contraception (i.e. oral contraceptives, intrauterine devices) to avoid pregnancy during the 2 months preceding the start of study treatment, throughout the study period and for up to 3 months after the last dose of oral vinorelbine in such a manner that the risk of pregnancy is minimised. Women of childbearing potential must have a negative serum or urine pregnancy test within 72 hours prior to the start of study treatment.
- •-Fertile men must be using an effective method of birth control if their partners are women of childbearing potential throughout the study period and for up to 3 months after the last dose of study treatment.
- •-The patient must have access to social insurance according to local regulations.
- •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 66
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 100
排除标准
- •Patients with at least one of the following criteria will not be included:
- •-Known hypersensitivity to the study drug or to drugs with similar chemical structures.
- •-Any important factor likely to modify drug absorption (e.g. surgery of the gastro-intestinal tract, significant malabsorption syndrome or disease affecting the gastro-intestinal tract function).
- •-Previous radiotherapy in the only site used to assess response.
- •-Clinically relevant or unstable systemic disease making implementation of the protocol difficult.
- •-Active brain metastases except for the followings:
- •Asymptomatic brain metastases which do not require local treatment in the opinion of the investigator;
- •Brain metastases for which local treatment has been given: at least 4 weeks off corticosteroids and/or anti-convulsants treatment before study randomisation.
- •-Meningeal carcinomatosis.
- •-Symptomatic neuropathy (sensory) > or equal grade 2 according to the NCI Common Toxicity Criteria (NCI – CTC version 4.0).
- •-Weight loss > 10% within the previous 3 months.
- •-Long term oxygen therapy.
- •-Concomitant/uncontrolled medical disorder (cardiac failure or myocardial infarction within the previous 3 months, heart failure NYHA class III-IV, uncontrolled hypertension or arrhythmia, uncontrolled hypercalcaemia, active infection requiring i.v. antibiotics within 2 weeks before the beginning of treatment).
- •-Symptomatic ascite or pericardial effusion.
- •-Women if pregnant or lactating or with positive pregnancy test at inclusion; woman of child-bearing potential who did not use or is unwilling or unable to use an acceptable method of contraception to avoid pregnancy during the 2 months preceding the start of study treatment, for the entire study period and for up to 3 months after the last dose of oral vinorelbine.
- •-Sexually active fertile men not using effective method of birth control method throughout the study period and for up to 3 months after the last dose of study treatment if his partner is a woman of childbearing potential.
- •-History of another malignancy within the past five years except basal cell carcinoma of the skin or carcinoma in situ of the cervix.
- •-Concomitant treatment with another anticancer or any experimental drug within 30 days prior to treatment period.
研究者
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