Background Immunotherapy of cancer has experienced tremendous breakthroughs over the past decades. Thus, the well characterized capacity of the immune system to recognize and kill cancer cells, is also being exploited in the clinic. However, predictive markers for response are largely missing, but infiltration into the tumor microenvironment has been shown in several studies to correspond to response. In this regard, we and others have shown in mouse tumor models, that exercise led to an adrenalin mediated increase in influx of T and NK cells into the tumor in turn improving the chance for response to CPI therapy.

Methods We have therefore established the clinical trial HI AIM to test this in patients. HI-AIM (NCT04263467, approval # by Danish ethical committee H-19031814) is a randomized controlled trial (70 patients,1:1) aimed to investigate if high-intensive training can mobilize and activate the immune system, and thereby enhance the effect of the immunotherapy in patients with lung cancer. Besides routine oncological measures, blood samples and biopsies, will form the basis for immunological measurements of various cancer and immune system markers. Preliminary results are based on flow cytometry and ELISA data, but we also plan to perform CyTOF, Luminex, single-cell sequencing and DNA-barcoding for T cells specificity and.

Results Preliminary data shows successful exercise-mediated mobilization of immune cells to the peripheral blood, together with increasing adrenaline and noradrenaline levels. To this end, we plan to share these initial promising results at the SITC 2023 meeting – where we expect to have included min. 50 out of 70 patients.

Conclusions We believe that the HI AIM study will produce important data in the field of exercise-oncology/immunology

Trial Registration NCT04263467, https://classic.clinicaltrials.gov/ct2/show/NCT04263467

Ethics Approval Approval number by Danish regional ethical committee H-19031814