The Addition of Ipilimumab to Carboplatin and Etoposide Chemotherapy for Extensive Stage Small Cell Lung Cancer (ICE)

Inclusion Criteria:

• 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 1.
• Men and women, 18 years of age and above.

Exclusion Criteria:

• 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.