EUCTR2015-005605-36-IT进行中（未招募）1 期
Thymosin alpha 1 plus maintenance therapy with the Standard of Care (SoC) chemotherapy plus cisplatin (or carboplatin) in patients with metastatic Non-Small Cell Lung Cancer (NSCLC), EGFR wild type - SCI-Ta1-NSCLC-CHEMO P2-001
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 140
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
入选标准
- •Age 18 years or older;
- •Histological or cytological confirmation of NSCLC (may be from initial diagnosis of NSCLC or subsequent biopsy). Only patients with available tissue samples will be enrolled;
- •Locally advanced or metastatic NSCLC, not amenable to curative surgery or radiotherapy ;
- •Measurable disease by Response Evaluation Criteria In Solid Tumours (RECIST) in a
- •lesion not previously irradiated or non-measurable disease;
- •Eastern Cooperative Oncology Group - performance status (ECOG-PS) 0-2;
- •Absolute neutrophil count (ANC) > 1.5 x 10 9 /liter (L) and platelets > 100 x 10 9 /L ;
- •Bilirubin level either normal or <1.5 x ULN;
- •AST (SGOT) and ALT (SGPT) <2.5 x ULN (=5 x ULN if liver metastases are present);
- •Serum creatinine <1.5 x ULN;
- •Effective contraception for both, male and female pts, if the risk of conception exists;
- •Recovery from all acute toxicities of prior therapies;
- •Provision of written informed consent to the analysis of biological markers (registration).
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 1
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 40
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 100
排除标准
- •Prior therapy with Thymosin alpha-1;
- •Prior therapy with a study drug ;
- •Newly diagnosed central nervous system (CNS) metastases that have not yet been treated
- •with surgery and/or radiation. Pts with previously diagnosed and treated CNS metastases or
- •spinal cord compression may be considered if they have evidence of clinically stable
- •disease (SD) (no steroid therapy or steroid dose being tapered) for at least 28 days;
- •Pregnancy or suspected pregnancy;
- •Any unresolved chronic toxicity from previous anticancer therapy that, in the opinion of
- •the investigator, makes it inappropriate for the patient to be enrolled in the study;
- •Known severe hypersensitivity to a study drug or anyof the excipients of this product;
- •Other co-existing malignancies or malignancies diagnosed within the last 5 years with the
- •exception of basal cell carcinoma or cervical cancer in situ;
- •Any evidence of clinically active interstitial lung disease (ILD) (patients with chronic,
- •stable, radiographic changes who are asymptomatic or patients with uncomplicated
- •progressive lymphangiticcarcinomatosis need not be excluded);
- •As judged by the investigator, any evidence of severe or uncontrolled systemic disease
- •(e.g., unstable or uncompensated respiratory, cardiac, hepatic or renal disease);
- •As judged by the investigator, any inflammatory changes of the surface of the eye;
- •Evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the patient to participate in the study.
研究者
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