SCLC trial with nivolumab and ipilimumab in limited disease (STIMULI)
Research type
Research Study
Full title
A randomised open-label phase II trial of consolidation with nivolumab and ipilimumab in limited-stage SCLC after chemo-radiotherapy
IRAS ID
202460
Contact name
Sanjay Popat
Contact email
Sponsor organisation
ETOP (European Thoracic Oncology Platform)
Eudract number
2013-002609-78
Clinicaltrials.gov Identifier
Duration of Study in the UK
6 years, 3 months, 1 days
Research summary
Research Summary
This is an open-label, randomized, phase II international multi-centre clinical trial with early interim analysis for safety. The patient population is limited-stage small cell lung cancer following completion of radical concomitant chemoradiotherapy and prophylactic cranial irradiation. Such patients are normally treated with observation alone. Here, patients will be randomised to combination nivolumab plus ipilimumab, followed by nivolumab maintenance (the experimental arm) or observation alone (the standard arm). The primary objective is to evaluate if patients in the experimental arm have a better outcome in terms of progression-free survival and overall survival, compared to patients treated with observation.
A total of approximately 325 patients will be enrolled in the chemoradiotherapy part in order to randomize 260 patients at an estimated accrual time of 3 years. In the United Kingdom approximately 33 patients are planned to take part in the study at 3 sites. The total trial duration is 7.5 years from enrollment of the first patient into the study. A biobank will be created with centralized samples for translational research, in those consenting for this, including whole blood, white cells, (in selected centres) and diagnostic FFPE blocks. Patients that relapse will be asked for a voluntary biopsy for translational analyses.Summary of Results
Is not currently available.REC name
North East - Newcastle & North Tyneside 2 Research Ethics Committee
REC reference
16/NE/0419
Date of REC Opinion
3 Feb 2017
REC opinion
Further Information Favourable Opinion