EUCTR2014-005096-85-GR进行中（未招募）1 期
Safety and Efficacy of LONQUEX® (Lipegfilgrastim) in Comparison to Pegfilgrastim (Neulasta®, Amgen Inc.) and Placebo in Patients with Non-Small-Cell Lung Cancer Receiving First-Line Chemotherapy
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
- Merckle GmbH
- 入组人数
- 300
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 is obtained
- •-The patient is a man or woman, aged 18 to 75 years
- •- Patients must have a histologically or cytologically confirmed, unresectable, advanced or metastatic (Stage IIIB/IV per American Joint Committee on Cancer [AJCC] 7th edition of tumors, nodes, and metastases classification of malignant tumors [TNM] staging) squamous or non-squamous (adenocarcinoma plus large cells) NSCLC
- •- The patient has at least non-measurable but evaluable disease lesion per Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1.
- •- The patient is planned and eligible to receive a maximum of 6 cycles of the predefined cisplatin/pemetrexed, or cisplatin/docetaxel, or paclitaxel/cisplatin CTX
- •- Have a life-expectancy of at least 18 weeks, according to the investigator’s assessment
- •- The patient is CTX naïve. Patients who received CTX in neoadjuvant or adjuvant setting, treated >12 months ago, will be eligible
- •- Eastern Cooperative Oncology Group (ECOG) performance status =2
- •- Absolute neutrophil count (ANC) =1.5 × 109/L
- •- Platelets =100 × 109/L
- •- Adequate hepatic, cardiac, bone marrow and renal function (creatinine clearance =45 mL/min per the standard Cockroft Gault formula) for the chosen CTX (cisplatin/pemetrexed, or cisplatin/docetaxel, or paclitaxel/cisplatin) regimen.
- •- Women of childbearing potential (not surgically sterile or 2 years postmenopausal) must use a medically accepted method of contraception and must agree to continue use of this method for the duration of the 6 CTX cycles and for 30 days after discontinuation of study drug. Acceptable methods of contraception include intrauterine device (IUD), steroidal contraceptive (oral, implanted, transdermal, or injected), barrier method with spermicide, partner vasectomy, and abstinence throughout the study (ie, true abstinence: when this is in line with the preferred and usual lifestyle of the subject. [periodic abstinence (eg, calendar, ovulation, symptothermal, post-ovulation methods), declaration of abstinence for the duration of a trial, and withdrawal are not acceptable methods of contraception]).
- •- The patient, if a man, is surgically sterile, or, if capable of producing offspring, is currently using an approved method of birth control and agrees to continued use of this method for the duration of the 6 CTX cycles (and for 90 days after taking the last dose of study drug because of the possible effects on spermatogenesis). Acceptable methods of contraception include abstinence (ie, true abstinence as detailed above), female partner’s use of an acceptable method of contraception (as described above), or if female partner is surgically sterile or 2 years post-menopausal. In addition, male patients may not donate sperm for the duration of the 6 CTX cycles and for 90 days after taking study drug.
- •- The patient must be willing and able to comply with study restrictions and to remain at the clinic for the required duration during the study period, and willing to return to the clinic for the follow-up evaluation as specified in this protocol.
- •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 225
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 75
排除标准
- •- Previous exposure to filgrastim, pegfilgrastim or lenograstim or other granulocyte colony stimulating factors (G-CSFs) in clinical development less than 6 months before randomization
- •- Participation in a clinical trial within 30 days or 5 half-lives of the investigational product before randomization, whichever is longer
- •- Known hypersensitivity to filgrastim, pegfilgrastim, lenograstim, cisplatin, pemetrexed, docetaxel or paclitaxel
- •- Patient meeting any contraindication for the chosen CTX regimen
- •- Patient to be treated with combined CTX/radiotherapy during the foreseen participation in this study
- •- Prior radiation therapy for lung cancer if not recovered from all toxicities related to this therapy
- •- Tumor surgery within 4 weeks before randomization
- •- Prior bone marrow or stem cell transplantation
- •- Progressive brain metastases
- •- Prior malignancy (other than NSCLC) within the preceding 5 years other than non-melanoma skin cancer or in situ cervical carcinoma
- •- The patient is a pregnant or lactating woman. (Any woman becoming pregnant during the study will be withdrawn from the study.)
研究者
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