Open trials

 

Accrual overview of ongoing ETOP trials

  STIMULI  SPLENDOUR    NICOLAS  PROMISE-meso BOOSTER
Enroled  Randomised  Randomised Enroled under protocol version Randomised Randomised
 v1.0  v2.0  v.3.0
 145 77 507  12  46  5 58 48

 

ETOP / IFCT 4-12 STIMULI is a randomised open-label phase II trial of consolidation checkpoint inhibitors ipilimumab and nivolumab in limited-stage SCLC after chemo-radiotherapy. Progression-free survival and overall survival are combined primary endpoints. The target sample size is 260 randomised patients. ETOP is the sponsor of the trial that is conducted in collaboration with the IFCT.

The trial is activated in Switzerland, Belgium, Germany, France, Spain and the United Kingdom. The activation of additional sites in Australia and New Zealand is currently in preparation.

 

ETOP 5-12 / EORTC 8111 SPLENDOUR  is a randomised, open-label, phase III trial evaluating the addition of denosumab, a monoclonal antibody targeting and inhibiting RANKL, to standard first-line anticancer treatment in advanced NSCLC. Target sample size is 1000 randomised patients. ETOP is the sponsor of this trial, which is conducted in collaboration with EORTC as coordinating group.

  

ETOP 6-14 NICOLAS is an international, multi-centre phase II feasibility trial evaluating the addition of anti-PD‑1 nivolumab to standard first-line chemotherapy and radiotherapy in locally advanced stage IIIA/B Non-Small Cell Lung Carcinoma. The primary endpoint of this trial is grad >3 pneumonitis.

The trial is conducted in Belgium, Germany, the Netherlands, Spain, and Switzerland.

 

In August 2017 the accrual goal of 43 patients has been reached. With an additional protocol amendment (amendment 2) the sample size has been increased to 78 patients in order to reach suffiicient power for an efficacy readout. The amendment 2 is currently activated in Switzerland, Spain and Belgium. Germany and the Netherlands will follow soon.

 

ETOP 8-15 PEARLS (EORTC-1416-LCG / KEYNOTE-091) is an international, triple-blinded, placebo-controlled randomized phase III trial. It will prospectively investigate the benefit of adjuvant treatment with pembrolizumab for one year versus placebo for early stage NSCLC patients, after completion of radical surgery (lobectomy/pneumonectomy) with or without standard adjuvant chemotherapy.

The target sample size is 1380 randomised patients. Merck Sharp & Dohme is the sponsor of this trial in all participating countries. The trial is currently activated in Austria, Belgium, Chile, Czech Republic, Denmark, Estonia, France, Germany, Greece, Hungary, Ireland, Israel, Italy, Japan, North Korea, Latvia, the Netherlands, Poland, Portugal, Slovenia, Spain, Switzerland, Turkey and the United Kingdom.

 

ETOP 9-15 PROMISE-meso is a randomised, open-label, phase III trial comparing pembrolizumab versus standard chemotherapy for advanced pre-treated malignant pleural mesothelioma. Mesothelioma is an aggressive malignancy most commonly affecting the pleura. Progression-free survival is the primary endpoint of this trial. Target sample size is 142 randomised patients. The trial is now activated in Switzerland and the United Kingdom. The activation of the sites in Spain is expected for November 2017.

 

ETOP 10-16 BOOSTER is a randomised, open-label, phase II trial comparing the third generation EGFR TKI osimertinib in combination with the angiogenesis inhibitor bevacizumab versus osimertinib alone as second-line treatment in stage IIIb-IVb NSCLC with activating EGFR and T790M resistance mutation.rogression-free survival is the primary endpoint of this trial. Target sample size is 153 randomised patients. The trial is activated in Switzerland, Ireland, Spain, South Korea, and Singapore. The Netherland will follow soon.