Open trials

 

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. ETOP is the sponsor of the trial that is conducted in collaboration with the IFCT.

The trial is activated in Switzerland, Belgium, Germany, France, and Spain. Activation in the United Kingdom is ongoing. The current accrual is 120 enroled patients, of which 66 have been randomised so far (46 under amendment 1).

 

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. ETOP is the sponsor of this trial, which is conducted in collaboration with EORTC as coordinating group.

The current accrual is 474 randomised patients, with 331 being contributed by ETOP sites. Main recruiting country is Spain, with 152 randomized patients.

  

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 trial is activated in Belgium, Germany, the Netherlands, Spain, and Switzerland. In Switzerland, four SAKK sites participate in the NICOLAS trial. The current accrual is 56 patients (44 under protocol amendment 1), 18 from Spain, 12 from the Netherlands, 9 from Switzerland, 9 from Germany,  and 8 from Belgium.

With an upcoming protocol amendment (AMD2) the sample size will be increased in order to reach suffiicient power for an efficacy readout. The accrual goal for the primary endpoint, grade >3 pneumonitis, has been reached and the recruitment into this trial is currently suspended until AMD2 is activated.

 

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 135 sites in Austria, Belgium, Denmark, Estonia, France, Germany, Greece, Hungary, Ireland, Israel, Italy, Japan, Netherlands, Poland, Portugal, Slovenia, Spain, Switzerland and United Kingdom. The current accrual is 220 randomised patients, 105 from ETOP sites.

 

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. The trial protocol was released on 15 November 2016 and the activation of the 15 sites from Switzerland, the United Kingdom and Spain is ongoing.

 

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.Switzerland, Ireland, the Netherlands, Spain, South Korea, and Singapore will participate in this trial with a total of 27 sites.

The current accrual is 8 patients.