EUCTR2009-016000-22-BG进行中（未招募）不适用
Efficacy and safety of XM22 in patients with non small cell lung cancer receiving cisplatin / etoposide chemotherapy.A multinational, multicentre, randomised, double-blind placebo-controlled study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 485
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
- •Signed and dated written informed consent.
- •Men and women aged =18 years
- •The patient must be able to understand and follow instructions and must be able to participate in the study for the entire period.
- •Patients with squamous NSCLC stage IIIB/IV, histologically or cytologically documented.
- •Patients planned and eligible to receive 4 cycles of the predefined cisplatin / etoposide-based, myelosuppressive CTX.
- •Life-expectancy of at least 4 months.
- •CTX naive.
- •Eastern Cooperative Oncology Group (ECOG) performance status =2.
- •ANC =1.5 x 10(9)/L.
- •Platelets =100 x 10(9)/L.
- •Adequate hepatic, cardiac, bone marrow and renal function for the chosen CTX regimen.
- •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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Participation in a clinical trial within 30 days before randomisation.
- •Previous exposure to filgrastim, pegfilgrastim or lenograstim or other G-CSFs in clinical development less than 6 months before randomisation.
- •Known hypersensitivity to filgrastim, pegfilgrastim, lenograstim, cisplatin or etoposide.
- •Patient planned for non-myelosuppressive chemotherapy.
- •Patients with an individual high risk for febrile neutropenia in respect of the cisplatin/etoposide CTX according to the assessment of the investigator. Risk factors are age >65 years, low performance status, poor nutritional status, and liver, renal or cardiovascular disease.
- •Patient meeting any contraindication for the chosen CTX regimen.
- •Treatment with systemically active antibiotics within 72 hours before CTX.
- •Treatment with lithium at inclusion or planned during the entire study.
- •Patient to be treated with combined chemo-/radiotherapy during the foreseen participation in this study.
- •Chronic use of oral corticosteroids (except low dose chronic treatment with =20 mg/day prednisolone or equivalent dose for chronic obstructive pulmonary disease).
- •Prior radiation therapy or tumour surgery within 4 weeks before randomisation.
- •Prior bone marrow or stem cell transplantation.
- •Prior malignancy within the preceding 5 years other than non-melanoma skin cancer or in situ cervical carcinoma.
- •Any illness or condition that in the opinion of the investigator may affect the safety of the patient or the evaluation of any study endpoint.
- •Pregnant or nursing women. Women of child-bearing potential who do not agree to use a highly effective method of birth control during the entire duration of the study.
研究者
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已完成
3 期
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