EUCTR2016-003015-34-HU进行中（未招募）1 期
A Phase II Open-Label, Randomized Study of Immunoconjugate L-DOS47 in Combination with Vinorelbine/Cisplatin Versus Vinorelbine/Cisplatin Alone in Patients with Lung Adenocarcinoma
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
- 136
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. Male or female aged = 18 years old
- •2. Histologically confirmed lung adenocarcinoma, classified as:
- •- Chemotherapy-naive patients with metastatic lung adenocarcinoma for whom vinorelbine/cisplatin would be appropriate therapy;
- •- Metastatic recurrent lung adenocarcinoma following prior surgery, radiation and/or adjuvant chemotherapy at least 6 months ago, for whom vinorelbine/cisplatin would be appropriate therapy;
- •- Staging must be assessed according to TNM, 8th edition and based on computed tomography (CT) scan;
- •- Grade 1 – 4 adenocarcinoma.
- •3. No prior adjuvant chemotherapy within 6 months of the first treatment day if there is recurrent disease
- •4. At least a single measurable lesion in accordance with the RECIST v1.1 criteria
- •5. Eastern Cooperative Oncology Group (ECOG) performance status: 0-1
- •6. A life expectancy of = 3 months
- •7. Adequate organ function as determined by the following criteria:
- •- Absolute neutrophil count (ANC) = 1.5 × 109/L
- •- Platelet count = 100 × 109/L
- •- Haemoglobin (HGB) = 9 g/dL
- •- Creatinine clearance = 60 mL/min calculated using the Cockcroft-Gault Formula and serum creatinine = 1.5 × the upper limit of normal (ULN)
- •- Serum aspartate aminotransferase (AST) and serum alanine aminotransferase (ALT) = 3 × ULN or < 5 × ULN if liver abnormalities are due to underlying malignancy
- •- Total bilirubin = 1.5 × ULN
- •Note: Blood transfusions administered for the sole purpose of meeting the study inclusion criteria between the time informed consent is signed and first dose of L-DOS47 is administered are not allowed.
- •8. Able to understand the information provided to them and to give written informed consent before any study activities are conducted
- •9. Willing and able to comply with scheduled visits, treatment plans, laboratory tests and other study procedures
- •10. Not pregnant and do not plan to become pregnant during the study. Females of childbearing potential must provide a negative pregnancy test within the Screening period (Day -21 to 0) and agree to use adequate non- hormonal contraception (which includes but is not limited to double barrier or sexual abstinence) during the study and for a period of 90 days following the last dose of study treatment. Male patients and their female partners of child-bearing potential must agree to each use an approved form of contraception (which includes but is not limited to double barrier or sexual abstinence) during the study and for a period of 90 days following the last dose of study treatment.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 78
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 58
排除标准
- •1. Pregnant or nursing mother
- •2. Prior history of other malignancies with the exception of non-melanoma skin cancer
- •3. Patients with a known positive Epidermal Growth Factor Receptor (EGFR) mutation or whose tumour harbour an anaplastic lymphoma kinase (ALK) translocation
- •4. Active central nervous system metastasis and/or leptomeningeal disease (known or suspected); Patients with asymptomatic brain metastases are eligible if they had local therapy more than 1 month before enrolment
- •5. Evidence of active infection
- •6. Received treatment in another clinical study within the 30 days before commencing study drug and have not recovered from side effects of a study drug, except for alopecia
- •7. A serious uncontrolled medical condition
- •8. Known positive human immunodeficiency virus (HIV), known hepatitis B surface antigen, or hepatitis C positive
- •9. Sustained QT interval corrected for heart rate (QTc) with Fridericia’s correction > 450 msec at Screening, or a history of additional risk factors for Torsades de pointes (e.g., heart failure, hypokalaemia, family history of long QT syndrome)
- •10. Pre-existing peripheral neuropathy Grade =1 CTCAE (v. 4.03)
- •11. Dementia or significantly altered mental status that would prohibit the understanding or rendering of informed consent or compliance with the requirements of the protocol
- •12. Received chemotherapy during the 30 days before study treatment start; are receiving radiotherapy, targeted therapy, hormonal therapy, immunotherapy, major surgery or other study drugs during the 4 weeks before study treatment start, and have not recovered from all treatment related toxicities to Grade = 1, except for alopecia. (Radiotherapy is allowed for the symptomatic treatment of bone metastases.)
- •13. Taking systemic steroids (other than inhalers or topical steroids) or other medication to suppress the immune system
- •14. Participating (or planning to participate) in any other clinical trial during this study
研究者
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