Open trials

Accrual overview of ongoing ETOP trials

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.

The trial has started enrolling patients in January 2015. After the excellent initial recruitment, the accrual rate has dramatically slowed down, potentially due to more attractive treatment alternatives for this patient population, in the context of a competitive landscape of ongoing immune-oncology clinical trials. Under the current accrual rate, the trial would complete only in 2024 and it is very improbable that the recruitment would speed up again in the near future. The trial Steering Committee has therefore decided to terminate the recruitment prematurely as per End of January 2018. No safety concerns led to this decision. Treatment and follow-up of all included patients continue as specified in the protocol. The trial results will be evaluated and published.

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. Switzerland, Spain and the United Kingdom are participating countries in this trial. The trial protocol was released in November 2016 and the first site activated in September 2017. The current accrual into the PROMISE-meso trial is much higher than anticipated and we expect recruitment of the targeted 142 randomized patients to be completed by the mid of this year.

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 advanced NSCLC with activating EGFR and T790M resistance mutation. The trial is activated in Switzerland, Ireland, Spain, South Korea, and Singapore.

ETOP 12-17 ALERT-lung is a single arm phase II trial, evaluating the activity of alectinib in pre-treated patients with RET-rearranged advanced NSCLC with the primary objective is to assess the efficacy of alectinib in terms of overall response. The trial protocol was release in September 2017. The trial will be conducted in Belgium, France, Germany, Ireland, Italy, the Netherlands, Portugal, Switzerland and Spain and site activation is currently ongoing.