Addition of Ipilumimab to Carboplatin and Etoposide chemotherapy for the first line treatment of extensive small cell lung cancer
- Conditions
- Topic: National Cancer Research NetworkSubtopic: Lung CancerDisease: Lung (small cell)CancerSmall cell lung cancer
- Registration Number
- ISRCTN14095893
- Lead Sponsor
- Southampton University Hospitals NHS Trust (UK)
- Brief Summary
2016 Results article in https://www.ncbi.nlm.nih.gov/pubmed/27296105 results
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 40
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Progression free survival; Timepoint(s): from consent to patient disease progression
- Secondary Outcome Measures
Name Time Method 1 year overall survival; Timepoint(s): survival one year from consent