NCT06567704 · Wake Forest University Health Sciences
Cancer-related Fatigue During Maintenance Immunotherapy for Non-small Cell Lung Cancer (NSCLC): a Qualitative Study
What this study is about
The purpose of this research is to understand cancer related fatigue in patients with non-small cell lung cancer (NSCLC), who are being treated with an immune checkpoint inhibitor.
View original scientific description
The purpose of this research is to understand cancer related fatigue in patients with non-small cell lung cancer (NSCLC), who are being treated with an immune checkpoint inhibitor.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- ≥ 18 years of age at the time of consent.
- Must be able to speak, read, and understand English.
- Participants diagnosed with NSCLC, and:
- have advanced/metastatic disease who are currently receiving immunotherapy monotherapy, or
- have locally advanced disease who are currently receiving immunotherapy monotherapy after completing thoracic radiation therapy, or
- who underwent resection and are currently receiving immunotherapy monotherapy after completing all other perioperative treatment
- Immunotherapy planned to continue for at least three months after the time of study enrollment (to ensure participant remains on IO long enough to obtain study assessments)
- Have completed at least two cycles of immunotherapy.
- Self-reported cancer-related fatigued that impacts daily function.
Exclusion criteria
- Participants who have received a dose of chemotherapy (including maintenance pemetrexed) within the past 3 months
- Participants who have received radiation therapy within the past 3 months. Note: a short course of palliative radiation therapy within up to 20 Gy and up to 5 fractions is permissible.
- Diagnosis of dementia.
- Anemia Hgb \<10 g/dL.
- Sarcopenia which is being pharmacologically treated with a prescribed appetite stimulant (e.g., megestrol).
- Untreated hypothyroidism.
- Symptomatic heart failure.
- Oxygen dependent lung disease.
- Cognitively unable to complete interviews per investigator.
Where
- Charlotte, North Carolina
- Winston-Salem, North Carolina
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Feb 3, 2026 · Source of record for eligibility and locations