Bright light therapy to help time immune therapy for melanoma and NSCLC

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This pilot study examines whether 60 minutes of daily bright light can synchronize circadian rhythms in patients about to begin first-line immune checkpoint blockade. The therapy is delivered through the Circadian OS iPad app for at least 7 days prior to initiating treatment. The primary goals are to assess feasibility and safety, with biological effects on circadian biology and potential implications for treatment timing. It is a single-arm study focusing on patients with measurable tumor burden who plan to receive anti-PD-1, anti-CTLA-4, or combinations. Enrollment is at Weill Cornell Medicine in New York, with collaboration from Circadian OS, Inc.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Age ≥18 years.
2. Histologically confirmed diagnosis of advanced, unresectable melanoma or NSCLC.
3. Presence of measurable tumor burden.
4. Scheduled to receive first-line cancer-directed therapy with an immune checkpoint blockade-containing regimen, as monotherapy or combination (e.g. pembrolizumab, ipilimumab + nivolumab, ICB + chemotherapy).
5. ECOG performance status 0-2.
6. Able to provide informed consent.
7. Access to reliable internet connection via WiFi or personal hotspot

Exclusion Criteria:

1. Previous exposure to immune checkpoint blockade.
2. Pregnant or breastfeeding.
3. Use of melatonin or pharmacologic sleep aids (e.g., zolpidem, trazodone, benzodiazepines) within 14 days prior to enrollment.
4. Diagnosis of bipolar disorder or history of mania or hypomania.
5. Active psychosis, suicidal ideation, or recent psychiatric hospitalization (\<3 months).
6. Poorly controlled seizures.
7. Chronotype classified as extremely early or extremely late, based on the Munich Chronotype Questionnaire (MSFsc \< 2:00 or \> 5:00).
8. Night shift work within the past 30 days or expected during the intervention.
9. Travel across ≥2 time zones within the past 14 days.
10. Diagnosed or suspected untreated moderate to severe obstructive sleep apnea.
11. Migraine with photophobia.
12. Presence of ocular or photosensitivity conditions affecting vision (i.e. advanced bilateral cataracts not yet operated, advanced glaucoma with substantial visual field loss, optic nerve disease, ocular surgery within the past 3 months with unresolved visual symptoms, color blindness).

Where it's running

• Weill Cornell Medicine
  New York, New York, United States Recruiting

Study contacts

• Principal investigator: Paul Chapman, MD — Weill Medical College of Cornell University
• Study coordinator: June Greenberg, BSN, RN, OCN, CCRP, CCRC
• Email: jdg2002@med.cornell.edu
• Phone: 212-746-2651

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.