New trials

 

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.

 

 

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 112 enroled patients, of which 61 have been randomised so far (41 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 462 randomised patients, with 322 being contributed by ETOP and 140 by EORTC sites. The eight participating SAKK sites recruited 88 patients. Main recruiting country is Spain, with 145 randomized patients. A protocol amendment, mainly relating to protocol clarifications, has been released on 22 February 2017. Site activation is ongoing.

  

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 131 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 205 randomised patients, 99 from ETOP sites (19 from Switzerland).

 

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 trial protocol was released on 13 December 2016 and the first patient was enroled on 31 May 2017 in Spain. Site activation in the remaining sites is still ongoing.

 

Closed trials

 

ETOP 3-12 EMPHASIS-lung is a multi-centre, open-label randomised phase III trial. The trial aimed at exploring a predictive effect of Veristrat, a serum proteomic test, regarding the efficacy of erlotinib versus docetaxel in patients with squamous NSCLC. The trial closed prematurely because of low accrual and results from other trials. The final analysis includes an exploratory combined analysis with results from the PROSE trial. The manuscript has been accepted for publication by the Journal of Thoracic Oncology: Peters S. et al., JTO 2017;12(4): 752-762. www.jto.org/article/S1556-0864(16)33607-3/fulltext

 

ETOP 2-11 BELIEF an open-label, single-arm, phase II multicentre trial exploring whether first-line erlotinib plus bevacizumab improves progression-free survival in NSCLC patients with activating EGFR mutations (del19 or L858R). The outcomes are tested overall and separately in patients with and without the pre-treatment EGFR T790M mutation. The accrual goal of 102 patients was reached in October 2014. Treatment and follow-up is still ongoing. The results have been published in May 2017 (Rosell R. et al Lancet Respiratory Medicine Volume 5, No. 5, p 435-444).

http://www.thelancet.com/journals/lanres/article/PIIS2213-2600(17)30129-7/fulltext

 

 ETOP 7-14 NICHE is a phase II, international multi-centre clinical trial sponsored and conducted by ETOP.
The primary objective is to evaluate the potential of afatinib to control disease in pre-treated patients with advanced NSCLC harbouring HER2 exon 20 mutations.

The trial was activated at the beginning of 2015. In total 13 patients from Spain, Germany and the Netherlands have been enroled into the trial. In November 2016, the accrual into the NICHE trial has been closed prematurely. Follow-up and treatment of the already enroled patients continues as planned. A poster with the first results was presented at ASCO 2017 in Chicago.