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 Ipili-MUmab 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 is 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

STIMULI trial design AM1

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.

 

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 End Date: -

Trial Organisation

Trial Chairs: Solange Peters and Dirk De Ruysscher
Sponsor: ETOP
Coordinating Groups: ETOP in collaboration with IFCT 
Participating Groups: ALTG/CTC, IFCT, SAKK and SLCG
Participating Countries:   Belgium, France, Germany, Netherlands, Spain, Switzerland, United Kingdom, Australia and New Zealand
Registrations:

EudraCT number: 2013-002609-78

ClinicalTrials.gov: NCT02046733  

 

Contact

Robin Schweri (Trial Manager)

Tel: +41 31 511 94 45

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European Thoracic Oncology Platform

c/o IBCSG

Effingerstrasse 40

3008 Bern, Switzerland

Tel: +41 31 511 94 00