National clinical study

LUCAGEN: Early detection of treatment failure by circulating tumor DNA in advanced non-small cell lung cancer

The purpose of the study is early detection of treatment failure in patients with advanced non-small cell lung cancer (NSCLC) without targetable mutations to prevent ineffective treatment and needless toxicity. We are performing a prospective exploratory study in order to:

1) assess how the levels of circulating tumor DNA (ctDNA) during treatment correlate to treatment response.

2) concurrently perform comprehensive molecular profiling to identify resistance mechanisms and molecular therapeutically actionable targets for a more effective treatment strategy.

3) assess how specific ctDNA variants and total cfDNA is associated with immune-mediated antitumor response in immunotherapy-treated NSCLC patients. NCT03512847

The project received funding in 2020 

Principal Investigator (PI)


Julie Gehl
Julie GehlProfessor
Department of Clinical Oncology, Zealand University Hospital


Malene Støchkel Frank
Malene Støchkel FrankPhD, Consultant, Clinical Research Associate Professor
Department of Clinical Oncology and Palliative Care, Zealand University Hospital | Department of Clinical Medicine, Copenhagen University | Chair of Danish Society of Clinical Oncology


Zealand University Hospital

Vejle Hospital

Aalborg University Hospital

Copenhagen University Hospital (Rigshospitalet)

Aarhus University Hospital

Institute of Clinical Molecular Biology, Kiel, Germany

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Patient enrollment


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Lung cancer
(Non-Small Cell Lung Cancer)

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Prospective observational

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Lung cancer is the leading cause of cancer related death. The introduction of new therapies in treatment of advanced non-small cell lung cancer during recent years, such as immunotherapy and targeted/personalized treatment has bettered the prognosis. Though the response rates are widely varying due to primary or acquired resistance. There is an urgent need of early detection of treatment failure and exploration of resistance mechanims to prevent long-lasting ineffective, costly treatments and to better treatment response through targeted treatment.

Purpose and Methods
In our research group a strong cross regional collaboration between Zealand University Hospital, Ålborg University Hospital, Vejle Hospital and Centre of Genomic Medicine, Rigshospitalet, has been established, enabling a high inclusion rate and high quality analyses and interpretation of results. In this prospective exploratory study, we aimed to assess how the levels of circulating tumor DNA (ctDNA), measured in plasma, during treatment correlate to treatment response. In addition we aimed to identify resistance mechanisms and molecular therapeutically actionable targets.

All relevant approvals have been obtained and we have included 218 patients. Preliminary results are promising, showing correlation between the level of ctDNA and response to treatment, and also the ability to reveal new resistance mutations during treatment. An abstract covering the preliminary results have been presented at the European Respiratory Society (ERS) International Congress 2020.

Based on the findings in this study, a national interventional study is planned to investigate the clinical utility and significance of liquid biopsy in monitoring treatment efficacy and treatment resistance in advanced NSCLC.



Science Center Skejby, MOMA
Brendstrupgårdsvej 21, build. A
8200 Aarhus N