EUCTR2013-001237-41-NO进行中（未招募）不适用
A Randomized Phase III Study Comparing Maintenance Pemetrexed Therapy After Induction Chemotherapy Versus Pemetrexed at Progression in Advanced Non-Small-Cell Lung Cancer
orwegian University of Science and Technology0 个研究点开始时间: 2013年4月12日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
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
- •1.No prior systemic therapy for advanced non-small-cell lung cancer (including EGFR-TKI). Previous chemotherapy (e.g. adjuvant after surgery or for other cancer) is allowed if = 3 months since the last course was administered.
- •2.Measureable disease according to the RECIST 1.1
- •3.Previous radiotherapy is acceptable provided there are measurable, previously not irradiated lesions present.
- •4.Histologically or cytologically confirmed non-squamous non-small cell lung cancer
- •5.No activating EGFR-mutation or ALK-translocation detected
- •6.Stage IIIB ineligible for curative therapy or stage IV disease
- •7.Age = 18 years
- •8.ECOG Performance 0-2
- •9.Adequate organ function defined as:
- •a.Serum aspartate transaminase (AST) and serum alanine transaminase (ALT) = 3 x upper limit of normal (ULN), or AST and ALT = 5 x ULN if liver function abnormalities are due to underlying malignancy.
- •b.Total serum bilirubin = 1.5 x ULN
- •c.Absolute neutrophil count (ANC) = 1.5 x 109/L
- •d.Platelets = 100 x 109/L
- •e.Creatinin clearance > 45 ml/min
- •10.No serious concomitant systemic disorders (for example active infection, unstable cardiovascular disease) that in the opinion of the investigator would compromise the patient’s ability to complete the study or interfere with the evaluation of the efficacy and safety of the study treatment
- •11.No conditions – medical, social, psychological – which could prevent adequate information and follow-up
- •12.No clinical active cancer other than NSCLC
- •13.No known hypersensitivity or contraindications for the study drugs (vinorelbine, carboplatin, pemetrexed, B12, folate,)
- •14.Able to discontinue NSAIDs and ASA if reduced renal function
- •15.No pregnancy or lactating women
- •16.All fertile patients should use safe contraception
- •17.Written informed consent
- •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 465
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 300
排除标准
- •See principal inclusion criteria
研究者
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