EUCTR2013-003156-21-PL进行中（未招募）1 期
A randomised, open-label phase III trial evaluating the addition ofdenosumab to standard first-line anticancer treatment in advancedNSCLC - SPLENDOUR: Survival imProvement in Lung cancEr iNduced by DenOsUmab theRapy
ETOP (European Thoracic Oncology Platform) c/o IBCSG Coordinating Center0 个研究点目标入组 1,000 人开始时间: 2015年12月21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
- 1,000
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 or cytologically confirmed advanced stage IV non-small cell lung carcinoma (NSCLC), according to 7th TNM classification
- •- Age = 18 years
- •- ECOG performance status 0-2
- •- Measurable or evaluable disease (according to RECIST 1.1 criteria)
- •- Availability of tumour tissue for translational research:
- •- preferred: FFPE block from primary tumour or metastasis,
- •- alternatively: cell block
- •- if no block available: 10 unstained slides with wax protection
- •- Adequate haematological function: neutrophils = 1.5 ×109/L, platelets = 100×109/L, and hemoglobin = 9 g/dL
- •- Adequate liver function:
- •- ALT = 3 × ULN ( = 5 × ULN if liver metastasis are present)
- •- Total bilirubin < 2 x ULN
- •- Adequate renal function: calculated creatinine clearance = 30 mL/min (according to the formula of Cockroft-Gault)
- •- Life expectancy of at least 3 months
- •- Women of childbearing potential, including women who had their last menstrual period in the last 2 years, must have a negative serum or urine pregnancy test within 14 days before beginning treatment
- •- All sexually active men and women of childbearing potential must use an effective contraceptive method during the study treatment and for a period of at least 5 months following the last administration of trial treatment
- •- Written Informed Consent must be signed and dated by the patient and the investigator prior to any trial-related intervention for
- •a) Trial treatment
- •b) Submission of biomaterial for central testing
- •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 550
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 450
排除标准
- •- Patients with presence of documented sensitizing EGFR activating mutation or ALK rearrangements (screening following local standards is optional, but strongly encouraged in non-squamous histology)
- •- Patients with documented brain metastases (systematic screening of patients not mandatory)
- •- Prior chemotherapy or molecular targeted therapy for metastatic disease, with the exception of neoadjuvant or adjuvant chemotherapy or definitive radiochemotherapy, if terminated more than 6 months before registration.
- •- Any investigational agent(s) within 30 days prior to randomisation
- •- Concurrent bisphosphonate administration
- •- Oral/ dental conditions (by visual inspection):
- •- Prior history or current evidence of osteomyelitis / osteonecrosis of the jaw
- •- Active dental or jaw condition which requires oral surgery
- •- Planned invasive dental procedure for the course of the trial
- •- Non-healed dental or oral surgery
- •- Evidence of any medical condition which would impair the ability of the patient to participate in the trial or might preclude therapy with trial drugs (e.g. unstable or uncompensated respiratory, cardiac, hepatic or renal disease, active infection, uncontrolled diabetes mellitus; uncontrolled arterial hypertension = 150/100 mmHg, history of myocardial infarction in the last 3 months)
- •- Documented active infection with Hepatitis B virus or Hepatitis C virus, known infection with human immunodeficiency virus (HIV)
- •- Known hypersensitivity to any of the components of the treatment
- •- Severe, uncorrected hypocalcaemia or hypercalcaemia
- •- hypercalcaemia: total calcium >3.1 mmol/l, corrected calcium (with albumin level) >3 mmol/l
- •- hypocalcaemia: total calcium <2 mmol/l, corrected calcium (with albumin level) < 1.9 mmol/l
- •- Legal incapacity or limited legal capacity
- •- Medical or psychological condition which in the opinion of the investigator would not permit the patient to complete the trial or sign meaningful informed consent
- •- Women who are pregnant or breastfeeding
- •- Any concurrent malignancy other than adequately treated basal or squamous cell carcinoma of the skin, in situ carcinoma of the cervix or bladder, in situ breast carcinoma. (Patients with a previous malignancy but without evidence of disease for = 2 years will be allowed to enter the trial)
- •- Any previous exposure to denosumab, with the exception of a maximum of 2 previous doses of denosumab (Prolia®) more than 6 month before enrolment for osteoporosis treatment/prevention
- •- Previous bisphosphonate exposure which
- •- exceeds 2 prior doses of i.v. bisphosphonates
- •- exceeds a cumulative exposure of 1 year oral bisphosphonates
研究者
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