ISRCTN55761467已完成3 期
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
BioGeneriX AG (Germany)0 个研究点目标入组 375 人开始时间: 2010年6月10日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 375
研究概览
简要总结
2015 results in: https://www.ncbi.nlm.nih.gov/pubmed/26155455 [added 16/01/2019] 2016 results in: https://www.ncbi.nlm.nih.gov/pubmed/27501966 [added 16/01/2019]
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Provide signed and dated written informed consent
- •2. Men and women aged =18
- •3. The patient must be able to understand and follow instructions and must be able to participate in the study for the entire period
- •4. Patients with NSCLC stage IIIB/IV, histologically or cytologically documented
- •5. Patients planned and eligible to receive 4 cycles of the predefined cisplatin / etoposide-based, myelosuppressive CTX
- •6. Life-expectancy of at least 4 months
- •7. CTX naïve
- •8. Eastern Cooperative Oncology Group (ECOG) performance status =2
- •9. Absolute Neutrophil Count (ANC) =1.5 x 10*9/L
- •10. Platelet count =100 x 10*9/L
- •11. Adequate hepatic function, i.e. ALT and AST <2.5 x ULN, alkaline phosphatase <5 x ULN, bilirubin 12. Adequate renal function, i.e. creatinine <1.5 x ULN
- •13. Adequate hepatic, cardiac, bone marrow and renal function for the chosen CTX regimen
排除标准
- •1. Participation in a clinical trial within 30 days before randomisation.
- •2. Previous exposure to filgrastim, pegfilgrastim or lenograstim or other G-CSFs in clinical development less than 6 months before randomisation.
- •3. Known hypersensitivity to filgrastim, pegfilgrastim, lenograstim, cisplatin or etoposide.
- •4. Patient planned for non-myelosuppressive CTX.
- •5. 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.
- •6. Patient meeting any contraindication for the chosen CTX regimen.
- •7. Treatment with systemically active antibiotics within 72 hours before CTX.
- •8. Treatment with lithium at inclusion or planned during the entire study.
- •9. Patient to be treated with combined chemo-/ radiotherapy during the foreseen participation in this study.
- •10. Chronic use of oral corticosteroids (except low dose chronic treatment with =20 mg/day prednisolone or equivalent dose for chronic obstructive pulmonary disease).
- •11. Prior radiation therapy or tumour surgery within 4 weeks before randomisation.
- •12. Prior bone marrow or stem cell transplantation.
- •13. Prior malignancy within the preceding 5 years other than non-melanoma skin cancer or in situ cervical carcinoma.
- •14. 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.
- •15. 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. Highly effective methods of birth control are defined as those which result in a low failure rate (i.e. less than 1% per year) when used consistently and correctly such as implants, injectables, combined oral contraceptives, hormonal IUDs, sexual abstinence or vasectomised partner. Female patients will be considered to be of child-bearing potential unless surgically sterilised by hysterectomy or bilateral tubal ligation, or post-menopausal for at least two years (Postmenopausal is defined as the time after which a woman has experienced twelve consecutive months of amenorrhea without a period).
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