Addition of Ipilumimab to Carboplatin and Etoposide chemotherapy for the first line treatment of extensive small cell lung cancer

ISRCTN ISRCTN14095893
DOI https://doi.org/10.1186/ISRCTN14095893
ClinicalTrials.gov (NCT) NCT01331525
Clinical Trials Information System (CTIS) 2010-021863-34
Protocol serial number 9618
Sponsor Southampton University Hospitals NHS Trust (UK)
Funders Bristol Myers Squibb Pharmaceuticals Ltd (UK), Cancer Research UK (CRUK) (UK)
Submission date
06/05/2011
Registration date
06/05/2011
Last edited
24/03/2022
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

http://cancerhelp.cancerresearchuk.org/trials/a-trial-looking-treating-small-cell-lung-cancer-ipilimumab-chemotherapy-ice

Contact information

Ms Debbie Hamid
Scientific

Clinical Trials Unit, MP 131, Tremona Road
Southampton
SO16 6YD
United Kingdom

d.hamid@soton.ac.uk

Study information

Primary study designInterventional
Study designNon-randomised; Interventional; Design type: Treatment
Secondary study designNon randomised study
Scientific titleA phase II trial of the addition of Ipilumimab to Carboplatin and Etoposide chemotherapy for the first line treatment of extensive small cell lung cancer
Study acronymICE Trial
Study objectivesPrimary 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.

Secondary Objectives:
To assess the response to and toxicity of the combination of ipilimumab with carboplatin and etoposide chemotherapy.

Immunological Objectives:
1. To examine whether ipilimumab stimulates a humoral immune response to onco-neuronal self-antigens
The results from the above measurement of antibodies against onco-neuronal antigens will be used to focus the cellular biomarker analysis and identify targets to assess cellular responses
2. To measure the effect of ipilimumab on CD8+ T-cells directed against onco-neuronal antigens, presumed to be responsible for the desired cytotoxic activity against cancer cells
3. To evaluate the immune response to non-neuronal antigens in the presence of ipilimumab
Ethics approval(s)Southampton & South West Hampshire REC Committee A, First MREC approval date 11/01/2011, 10/H0502/95
Health condition(s) or problem(s) studiedTopic: National Cancer Research Network; Subtopic: Lung Cancer; Disease: Lung (small cell)
InterventionCarboplatin, Combination chemo for 6 cycles; Etoposide, Combination chemotherapy for 6 cycles; Ipilimumab, to be ngiven during cycles 3 - 6 and then as maintenance therapy every 12 weeks; Follow Up Length: 12 month(s); Study Entry : Registration only
Intervention typeDrug
PhasePhase II
Drug / device / biological / vaccine name(s)Ipilumimab, carboplatin, etoposide
Primary outcome measure(s)

Progression free survival; Timepoint(s): from consent to patient disease progression

Key secondary outcome measure(s)

1 year overall survival; Timepoint(s): survival one year from consent

Completion date29/05/2014

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexAll
Target sample size at registration40
Key inclusion criteria1. 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
Key exclusion criteria1. 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
Date of first enrolment30/06/2011
Date of final enrolment29/05/2014

Locations

Countries of recruitment

  • United Kingdom
  • England

Study participating centre

Clinical Trials Unit
Southampton
SO16 6YD
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to shareNo
IPD sharing plan summary
IPD sharing planNot provided at time of registration

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/09/2016 Yes No
HRA research summary 28/06/2023 No No
Plain English results 24/03/2022 No Yes
Study website Study website 11/11/2025 11/11/2025 No Yes

Editorial Notes

24/03/2022: Plain English results added.
11/12/2017: Publication reference added

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