Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:32 AM
Ignite Modification Date:
2025-12-25 @ 12:32 AM
NCT ID:
NCT04263467
Eligibility Criteria:
Inclusion Criteria:
* 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
Exclusion Criteria:
* Any physical condition that hinder the execution of physical exercise, as assessed by the referring oncologist and by a physiotherapist
* Severe dyspnea that hinder the execution of high intensity aerobic exercise training, as assessed by the referring oncologist
* Symptomatic brain metastases
* Dementia, psychotic disorders, or other cognitive diseases or conditions that hinder participation in a clinical exercise-based trial, as assessed by the referring oncologist
* 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
* Use of beta blockers
* Any systemic infections within the last 4 weeks
* Patients who receives chemotherapy as monotherapy
* 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04263467
Study Brief:
Protocol Section:
NCT04263467