High Intensity Aerobic Exercise Training and Immune Cell Mobilization in Patients With Lung Cancer (HI AIM)

Prior treatment

• Unstable medical disease or history of serious or concurrent illness; any medical condition that might be aggravated by exercise training or that cannot be controlled, including, but not restricted to congestive heart failure (NYHA class III-IV), unstable angina pectoris, implantable cardioverter defibrillator (ICD), or myocardial infarction within 6 months
• A condition requiring systemic treatment with either corticosteroids (\> 10 mg daily prednisone equivalents) or other immunosuppressive medications. Inhaled or topical steroids and adrenal replacement doses ≤ 10 mg daily prednisone equivalents are permitted
• Patients who receives chemotherapy as monotherapy

Other illness

• Any physical condition that hinder the execution of physical exercise, as assessed by the referring oncologist and by a physiotherapist
• Dementia, psychotic disorders, or other cognitive diseases or conditions that hinder participation in a clinical exercise-based trial, as assessed by the referring oncologist
• Any systemic infections within the last 4 weeks

Other

• Severe dyspnea that hinder the execution of high intensity aerobic exercise training, as assessed by the referring oncologist
• Symptomatic brain metastases
• Use of beta blockers
• In patients with documented bone metastases; patients with:
  • A bone metastatic burden or location that poses a risk of injury in the performance of exercise training, as assessed by the referring oncologist

• Metastatic non-small cell lung cancer
• Measurable disease according to RECIST 1.1
• Age ≥ 18 years
• Treatment with immune checkpoint inhibitors, checkpoint inhibitors combined with chemotherapy or oncological surveillance
• Eastern Cooperative Oncology Group (ECOG) performance status score (PS) ≤2
• Preferably metastasis suitable for biopsy
• Normal marrow function as defined below:
  • White blood cell count (WBC) ≥ 2 x 10⁹/L
  • Absolute neutrophil count (ANC) ≥ 1.5 x 10⁹/L
  • Hemoglobin ≥ 6.0 mmol/l
  • Platelet count ≥ 100 x 10⁹/L
  • In case, a patient's bone marrow values fall slightly below the described values, the treatment responsible doctor will be consulted. The general health and the ability to proceed with the treatment will be considered.
• Ability to speak and read Danish
• Willingness to give informed consent for participation in the study