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First Phase I clinical study conducted in Luxembourg

27.02.19
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First Phase I clinical study conducted in Luxembourg

For the first time, one of Luxembourg’s hospitals, the Centre Hospitalier de Luxembourg (CHL), is taking part in a Phase I international clinical trial, involving as well the CIEC from LIH. In this trial, a tri-therapy is assessed among patients suffering from non-small cell lung cancer (NSCLC).

The cancer centre “Kriibszentrum” at CHL and the Clinical and Epidemiological Investigation Centre (CIEC) at LIH’s Department of Population Health have been participating for several months in the Phase I of the international clinical trial SPRING. This is the first global clinical trial evaluating the benefits of the combination of three targeted drugs on patients with advanced and/or metastatic NSCLC.

The clinical research project explores the use of a tri-therapy consisting of an immune checkpoint inhibitor (avelumab), a tyrosine kinase inhibitor that targets vascular tumour growth (axitinib) and an inhibitor of kinases involved in cell cycle regulation (palbociclib). During Phase I of the trial, the tri-therapy will be tested at different doses following a specific dose-escalation scheme with the aim to determine the tolerability of the combination of the three drugs. Phase I shall allow to identify the optimal doses to be administered to patients during Phase II, which will study the treatment’s effectiveness.

‘This is pioneering work for Luxembourg,’ tells Dr Romain Nati, Director General of the CHL. ‘Until now, no Luxembourg hospital had been included in a Phase I study, which corresponds to the first use of a new treatment for humans’. The study is conducted under the lead of Dr Guy Berchem, physician in oncology at the CHL and Head of the Laboratory of Experimental Cancer Research at LIH’s Department of Oncology.

 

 

 

 

 

 

 

 

 

To start the study, a lot of preparation work was needed to fulfill all clinical and regulatory requirements. At this stage, the support of LIH’s Clinical and Epidemiological Investigation Centre that has a long-term experience in assisting clinical trials in Luxembourg and abroad was essential. ‘It is important to guarantee to the CHL patients who have agreed to be included in the study that all the necessary precautions have been taken regarding their safety’, underlines Prof Laetitia Huiart, Director of LIH’s Department of Population Health.

The CHL aims to conduct further Phase I clinical trials in the future to broaden its treatment options, namely in the “Kriibszentrum”, and offer patient-tailored therapies.

About SPRING

The clinical research project SPRING - Survival Prolongation by Rational Innovative Genomics - is conducted as part of the international consortium WIN - Worldwide Innovative Network in Cancer Personalised Medicine. WIN brings together 40 institutions in 17 countries to accelerate translational and clinical research in the field of personalised medicine to the benefit of patients. To provide a therapeutic solution for the majority of patients with advanced and/or metastatic NSCLC, SPRING implements a strategy that is based on improved tumour characterisation, the combination of therapies - inspired from the fight against HIV AIDS - and the use of an algorithm to better predict the response of each patient.

This communication is derived from a press release of the CHL.

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