Recruiting

Observational Study

Sponsor:

Wake Forest University Health Sciences

Code:

NCT06567704

Conditions

Non-small Cell Lung Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Interviews

Study Details

Brief summary:

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.

Conditions

Non-small Cell Lung Cancer

Study ID

NCT06567704

Start date

Mar 26, 2025

Status verified date

Aug, 2026

Completion date

Jul, 2027

Anticipated

Primary completion date

Jan, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

20 participants

Anticipated

Interventions and Outcome Measures

Arms

Non-small cell lung cancer (NSCLC)

Non-small cell lung cancer (NSCLC) patients treated with with immune checkpoint inhibitor.

Interventions

Interviews

Interviews

Primary outcome measure

  • Themes from qualitative interviews with patients [ Time Frame: At 3 months ]

Central Contacts and Locations

Central contacts

Megan Lattanze

(980) 442-4239Megan.Lattanze@advocatehealth.org

Locations

Atrium Health Levine Cancer

Recruiting

Charlotte, North Carolina, United States, 28204

Contacts

Megan Lattanze

(980) 442-4239Megan.Lattanze@advocatehealth.org

Principal Investigator:

Dori Beeler, PhD

Wake Forest Baptist Comprehensive Cancer Center

Recruiting

Winston-Salem, North Carolina, United States, 27157

Contacts

Dori Beeler, PhD

980-442-7883Dori.Beeler@advocatehealth.org

Principal Investigator:

Dori Beeler

More Information

Sponsor

Wake Forest University Health Sciences

Last update posted

Aug 10, 2026

Last verified

Aug, 2026

Keywords

  • Cancer related fatigue
  • Immune checkpoint inhibitor

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Wake Forest University Health Sciences on 2026-08-10.