ISRCTN14095893已完成2 期
A phase II trial of the addition of Ipilumimab to Carboplatin and Etoposide chemotherapy for the first line treatment of extensive small cell lung cancer
Southampton University Hospitals NHS Trust (UK)0 个研究点目标入组 40 人开始时间: 2011年5月6日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 40
研究概览
简要总结
2016 Results article in https://www.ncbi.nlm.nih.gov/pubmed/27296105 results
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Willing and able to give written informed consent
- •2. Histological or cytological diagnosis of small cell lung cancer
- •3. Adequate baseline laboratory tests
- •4. No active or chronic infection with human immunodeficiency virus (HIV), hepatitis B, or hepatitis C.
- •5. Performance status Eastern Cooperative Oncology Group (ECOG) 0 or 1
- •6. Men and women, 18 years of age or more. ; Lower Age Limit 18 no age limit or unit specified
排除标准
- •1. Limited stage small cell lung cancer appropriate for radical treatment with chemoradiation
- •2. Symptomatic central nervous system (CNS) metastases
- •3. A history of prior malignant tumour, unless the patient has been without evidence of disease for at least 5 years, with the exception of adequately treated basal or squamous cell skin cancer, superficial bladder cancer or carcinoma in situ of the cervix
- •4. Clinically significant autoimmune disease
- •5. Any underlying medical, neurological or psychiatric condition, which in the opinion of the investigator will make the administration of ipilimumab hazardous or obscure the interpretation of adverse effects (AEs).
- •6. Administration of any live vaccine for prevention of infectious diseases (for up to 1 month before or after any dose of ipilimumab)
- •7. Previous chemotherapy for small cell lung cancer
- •8. A history of prior treatment with immunostimulatory antibodies ipilimumab, prior CD137 agonist or CTLA 4 inhibitor or agonist
- •9. Concomitant therapy with any of the following: interleukin 2, interferon, or other non-study immunotherapy regimens; immunosuppressive agents; other investigation therapies; or chronic use of systemic corticosteroids
- •10. Women of childbearing potential (WOCBP), as defined in the protocol and who:
- •10.1. Are unwilling or unable to use an acceptable method of contraception to avoid pregnancy for the duration of their participation in the study and for at least 8 weeks after cessation of study drug
- •10.2. Have a positive pregnancy test at baseline
- •10.3. Are pregnant or breastfeeding
研究者
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