A Phase II Trial of the Addition of Ipilimumab to Carboplatin and Etoposide Chemotherapy for the First Line Treatment of Extensive Stage Small Cell Lung Cancer (ICE)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 42
- 试验地点
- 7
- 主要终点
- To establish the progression free survival at 1 year in patients with extensive stage small cell lung cancer treated with ipilimumab, carboplatin and etoposide.
研究概览
简要总结
This trial will investigate the addition of an antibody (Ipilimumab) to conventional Carboplatin and Etoposide chemotherapy in extensive stage small cell lung cancer.
The primary objective is to establish the progression free survival at 1 year.
详细描述
A Phase II trial of the addition of Ipilimumab to Carboplatin and Etoposide chemotherapy for the first line treatment of extensive stage small cell lung cancer (ICE)
Indication:
Extensive Stage Small cell lung cancer
Primary Objective:
To establish the progression free survival at 1 year in patients with extensive stage small cell lung cancer treated with ipilimumab, carboplatin and etoposide.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Willing and able to give written informed consent.
- •Histological or cytological diagnosis of small cell lung cancer.
- •Adequate baseline laboratory tests.
- •No active or chronic infection with HIV, Hepatitis B, or Hepatitis C.
- •Performance status ECOG 0 or
- •Men and women, 18 years of age and above.
排除标准
- •Limited stage small cell lung cancer appropriate for radical treatment with chemoradiation.
- •Symptomatic CNS metastases.
- •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.
- •Clinically significant autoimmune disease.
- •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 AEs.
- •Administration of any live vaccine for prevention of infectious diseases (for up to 1 month before or after any dose of ipilimumab).
- •Previous chemotherapy for small cell lung cancer.
- •A history of prior treatment with immunostimulatory antibodies ipilimumab, prior CD137 agonist or CTLA 4 inhibitor or agonist.
- •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.
- •Women of childbearing potential (WOCBP), as defined in the protocol and who:
- •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, or
- •Have a positive pregnancy test at baseline, or
- •Are pregnant or breastfeeding.
研究组 & 干预措施
Single stage non-randomised
Patients will receive Carboplatin and Etoposide. Both Chemotherapy drugs will be delivered as a 21 day cycle (q21) with up to a maximum of 6 cycles delivered according to response unless progressive disease (RECIST Version 1.0) and or excessive toxicity.
Ipilimumab will be administered at a dose of 10mg/kg IV on day 1 of cycles 3-6 of Chemotherapy.
In the absence of immune related progression of disease or unacceptable toxicity, subsequent maintenance doses of Ipilimumab will be delivered every 12 weeks starting at week 30 at a dose of 10 mg/kg until unacceptable toxicity or immune related disease progression
干预措施: Ipilimumab (Biological)
结局指标
主要结局
To establish the progression free survival at 1 year in patients with extensive stage small cell lung cancer treated with ipilimumab, carboplatin and etoposide.
时间窗: At 1 year from entering trial
次要结局
- Assess tumour response and toxicity of ICE combination. Response measured by RECIST and immune related response criteria. Toxicity via physical exam, adverse event review, assessing signs and symptoms, quality of life assessment and blood testing.(Throughout clinical trial participation (maximum 6 21 day cycles) plus 100 day follow up from last treatment.)