A randomised open-label phase II trial of consolidation with nivolumab and ipilimumab in limited-stage SCLC after chemo-radiotherapy

STIMULI: Small cell lung carcinoma trial with nivolumab and ipilimumab in limited disease

Chemo-radiotherapy is the current standard treatment approach in limited-stage (stage I-IIIB) small cell lung carcinoma (SCLC) with a median survival of 16 to 24 month and only 15 – 25% long-term survivors.

Nivolumab and ipilimumab are humanized monoclonal antibody that target the immune checkpoint receptors PD-1 and CTLA-4, respectively and inhibit the interaction with their ligands.

The aim of the trial was to evaluate whether nivolumab plus ipilimumab consolidation treatment after completion of standard chemo-radiotherapy and prophylactic cranial irradiation is superior in terms of overall survival and progression-free survival compared to standard chemo-radiotherapy and prophylactic cranial irradiation alone.

Trial Scheme

Trial Treatment

Patients who are randomised to the experimental arm will receive nivolumab 1mg/kg and ipilimumab 3 mg/kg in the induction phase, followed by 240mg nivolumab as maintenance treatment for 1 year. A maximum of one cycle of platinum based chemotherapy can be administered before enrolment. In this case radiotherapy should optimally start concomitantly with chemotherapy cycle 2 and no later than cycle 3.

Trial Information

Primary Endpoints:
Progression free survival and Overall survival
Secondary Endpoints:
Objective response
Time to treatment failure
Toxicities of treatment 
Target Sample Size:
260 Randomized Patients
Final Accrual:
174 Randomized Patients
Protocol Release Date:
December 2013 / AMD1 September 2015
Trial Activation Date:
25 April 2014
First Patient In:
28 July 2014
Accrual Closure Date:
30 April 2019
Global Trial Completion Date:
27 January 2022

Trial Organisation

Trial Chairs: 
Solange Peters and Dirk De Ruysscher
ETOP IBCSG Partners Foundation
Coordinating Groups:
ETOP IBCSG Partners Foundation in collaboration with Intergroupe Francophone de Cancérologie Thoracique (IFCT)
Participating Groups: 
Australasian Lung Cancer Trials Group (ALTG/CTC), Intergroupe Francophone de Cancérologie Thoracique (IFCT), Swiss Group for Clinical Cancer Research (SAKK) and Spanish Lung Cancer Group (SLCG)
Participating Countries:  
Belgium, France, Germany, Netherlands, Spain, Switzerland, United Kingdom, Australia
EudraCT number: 2013-002609-78
ClinicalTrials.gov: NCT02046733  


ETOP IBCSG Partners Foundation
Effingerstrasse 33
3008 Bern, Switzerland