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2021-04-12

DZL Funds Four More Clinical Trials – Significant Contribution to Translational Research

News 2021-151 EN

The road from discovery in the laboratory to medical innovation is often a long one. Only a fraction of newly discovered pharmaceutical agents will make it to actual administration to the patient. The average development time is about 15 years. The aim of translational research at DZL is to speed up the process of taking research results from the laboratory into the clinic ( aka “bench to bedside“).

One of the key elements in this process are clinical trials. Hence, every year, DZL allocates part of its budget to innovative clinical trials that are based on initiatives by DZL scientists (Investigator Initiated Trials). These funds that are allocated through a competitive process enable researchers to react to the most recent developments in their field and further develop the findings as quickly as possible to the benefit of the patients. This is how DZL has already managed to achieve vital translational successes, such as, most recently, in the field of interstitial (diffuse parenchymal) lung diseases.

Moreover, DZL researchers may apply for special funds as regards financing the preparation and drafting of applications for clinical trials. This measure is to support researchers in applying for clinical trials with both the DZL and other sponsors such as the German Research Association (DFG) or the German Federal Ministry of Education and Research (BMBF).

DZL has come to a decision as to the funding of clinical trials in the new funding period: four more trials, which will be described more specifically hereinafter, will be funded as of 2021. Moreover, three more applications will be funded.

Study of Preoperative Immunotherapy in NSCLC - The Neomun Trial

The Neomun Trial is a joint project of the sites in Heidelberg (TLRC) and Giessen/Marburg (UGMLC). In a non-randomized phase II trial, Thorax Clinic Heidelberg and Max Planck Institute for Heart and Lung Research investigate the effects of neoadjuvant anti-PD-1 immunotherapy in patients with non-small cell lung cancer (NSCLC) on tumor response depending on tumor immune signature. The study is co-financed by the MSD Investigator Initiated Studies Program as well as the NCT PoCT program.

Over a time period of three years, 30 patients receiving Pembrolizumab therapy prior to surgical tumor removal will be compared to 30 patients without prior immunotherapy. Feasibility, safety, and efficacy of this therapy option are to be assessed by its effects on clinical and pathological tumor response. Simultaneously, researchers want to analyze potential prognosticating biomarkers and the functioning of anti PD-1 therapies in a neoadjuvant context with operable NSCLC.

Study on the Eradication of Pseudomonas Aeruginosa in Bronchiectasis Disease - ERADICATE Trial

With regard to disease progression of bronchiectasis, chronic Pseudomonas aeruginosa (PA) infection poses a particular problem as it is associated with increased morbidity and mortality. Hence, in clinical practice, PA eradication is frequently attempted upon first evidence. Up until now, however, there has not been sufficient evidence for this approach, and moreover, treatments are often off-label.

Researchers at the DZL sites in Munich (CPC), Hanover (BREATH), and Giessen/Marburg (UGMLC) are convinced that preventing the chronification of a PA infection is vital for the further clinical course of bronchiectasis disease. Co-funded by the company Pari, the effects of an eradication attempt during 4 weeks of treatment with inhaled Colistin are to be assessed. This randomized trial is to provide a reliable data basis for eradication therapy during early PA infection in bronchiectases.

Study on Early Detection and Prevention of Transplant Failure  - CatBOF

Bronchiolitis obliterans syndrome (BOS) is the main cause of chronic lung allograft dysfunction (CLAD) following lung transplantation. Researchers at the DZL site in Munich (CPC) have established that the enzyme cathepsin B is significantly more active in those affected by BOS. In collaboration with the site in Giessen/Marburg (UGMLC), these scientists now plan to investigate whether this enzyme can offer a therapeutic approach to prevent the progression of BOS.

Until 2023, patients post lung transplantation are to be examined in two stages. Firstly, patients who underwent lung transplant surgery between 2013 and 2015 will be reviewed retrospectively with regard to enzyme activity. Secondly, follow-up visits with current lung transplant patients are conducted to validate the results. The aim is to achieve an early diagnosis of BOS and hence improve long-term survival of transplant patients.

Study on Establishing Early Screening for Lung Cancer – Hanse Trial

U.S. and European studies show that lung cancer mortality rates can be significantly reduced by early detection. Scientists at the DZL sites of the Northern Alliance ARCN and Hanover (BREATH) expect that lung cancer screening using low-dose computed tomography (LDCT) will also be possible in Germany after a positive evaluation by the IQWiG and could be covered by statutory health insurances.

Co-financed by AstraZeneca, the HANSE trial is designed such that it investigates still unresolved issues of a quality-controlled lung cancer screening program, e.g. defining and addressing the at-risk population as well as cost efficiency. Moreover, the effects of other markers extracted from LDCT, such as emphysema and coronary calcium scores, on lung and heart health are examined.

 

 

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