2023 World Conference on Lung Cancer (Posters)-P1.11. DYNAMALK: Dynamic ctDNA Profiling in ALK+ NSCLC. A Study of the Australian Registry and Biobank of Thoracic Cancers AURORA

P1.11. DYNAMALK: Dynamic ctDNA Profiling in ALK+ NSCLC. A Study of the Australian Registry and Biobank of Thoracic Cancers AURORA - PDF(Slides)

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DYNAMALK is a clinical trial conducted in Australia that aims to study the role of dynamic circulating tumor DNA (ctDNA) profiling in anaplastic lymphoma kinase (ALK) non-small cell lung cancer (NSCLC) patients. ALK NSCLC is a rare and biologically unique subgroup of lung cancer, and while ALK inhibitors have shown survival benefits, there is still unpredictability in patient outcomes. The trial aims to provide real-world evidence on the performance of ALK inhibitors based on broader molecular resistance profiles, including the use of real-time ctDNA testing for selecting the next line of therapy and monitoring treatment response.<br /><br />The primary outcomes of the study are to describe the detailed clinicopathologic and temporal ctDNA findings in ALK NSCLC patients and to assess the proportion of participants whose clinical management changed based on their ctDNA profiles. The secondary outcomes include assessing the concordance of ctDNA results with tissue molecular results, evaluating the turnaround time of ctDNA testing, and identifying molecular sub-groups of interest. Tertiary outcomes involve exploring novel predictive and prognostic biomarkers and correlating metabolic findings from PET scanning with plasma molecular profiles.<br /><br />DYNAMALK is a multi-center, prospective observational cohort study conducted within the Australian Registry and Biobank of Thoracic Cancers (AURORA) platform. The trial is open at Royal North Shore Hospital and Peter MacCallum Cancer Centre and is expected to open at other AURORA sites. Referrals are accepted Australia-wide, and ctDNA kits can be shipped remotely. The trial aims to optimize patient treatment and survival through personalized best practice and to improve the visibility and accessibility of ctDNA testing in routine clinical practice.<br /><br />The trial procedure involves collecting ctDNA samples, shipping them for analysis, and providing the results electronically. The study will be conducted over a period of 16 months, and patients will be followed up for 36 months after enrollment. The trial has two arms, one for treatment-naïve patients and another for pre-treated patients, with funding support from Pfizer and philanthropic campaigns.<br /><br />Overall, DYNAMALK aims to provide valuable insights into the use of ctDNA profiling in ALK NSCLC patients in order to improve clinical management and patient outcomes.

Asset Subtitle

Malinda Itchins

Meta Tag

Speaker Malinda Itchins

Topic Tumor Biology: Translational Biology - Omics and New Technologies

Keywords

DYNAMALK

clinical trial

Australia

dynamic circulating tumor DNA

ctDNA profiling

anaplastic lymphoma kinase

ALK non-small cell lung cancer

real-time ctDNA testing

ALK inhibitors

molecular resistance profiles