Trial Details
Trial status:
Closed
Recruitment start date:
14/03/2017
Funder:
London Lung Cancer Group
Sponsor:
UCL
Chief Investigator:
Dr. Siow Ming Lee
Recruitment target:
112
EudraCT number:
2015-004170-15
Contact details:
ctc.study15@ucl.ac.uk
Lay summary:
Study 15
A multicentre, randomised trial comparing combination gemcitabine/carboplatin and hydroxychlroquine with carboplatin/etoposide therapy in extensive stage small cell lung cancer (SCLC)
Description
Design: Study 15 is a multicentre, randomised trial comparing combination gemcitabine/carboplatin and hydroxychloroquine (HCQ) versus carboplatin/etoposide therapy alone in small cell lung cancer. 
Treatment: All patients are randomised to receive between 4-6 cycles of chemotherapy. Patients who are randomised to the investigational arm of the trial will begin administering HCQ on day 1 of the first cycle of chemotherapy. These patients will continue to take HCQ for a maximum of 30 months. On completion of chemotherapy, all patients will be followed up monthly for the first year and then two monthly for the next two years (maximum of 36 months). 
Key inclusion/exclusion criteria: Patients must have histologically or cytologically confirmed stage IV SCLC, an ECOG performance status of between 0-2, life expectancy of greater than 8 weeks, adequate renal function and bone marrow reserve and agree to use highly effective contraception if of reproductive potential. Patients must also have one site of measurable disease (target lesion) for RECIST v1.1 evaluation. Patients who have a history of macular degeneration/diabetic retinopathy, abnormal bilirubin levels, prior treatment for the SCLC or symptomatic brain metastases among other exclusions will not be eligible for the trial. 
Duration of recruitment: Anticipated recruitment for the trial is 39 months. 
Aim
To determine whether the combination of gemcitabine/carboplatin with hydroxychloroquine (HCQ) is associated with an improved clinical outcome (progression free and overall survival) compared with chemotherapy alone in patients with small cell lung cancer (SCLC). 
Trial protocols
Trial protocols must not be applied to patients treated outside trials. UCL CTC can only ensure that approved trial investigators are provided with amendments to protocols.
No protocols have been currently made available for download
Trial documents
No documents have been currently made available for download
Contact Us
Cancer Research UK & UCL Cancer Trials Centre
University College London
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London
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Email:
ctc.enquiries@ucl.ac.uk
Telephone:
+44 (0)20 7679 9898 (General CTC Enquiries)
Fax:
020 7679 9899
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