Bright Light Therapy in Patients With Melanoma or Non-small Cell Lung Cancer (NSCLC) Who Are Receiving First-Line Immune Checkpoint Blockade

NCT07661966 | Not Yet Recruiting FDA Device

• 1 other identifier: 25-10029453
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

This study is being done to test whether bright light therapy can be used to synchronize patients' circadian rhythms and allow ICB (immune-checkpoint blockade) therapy to be administered at a time in the circadian rhythm that optimizes clinical outcomes. This trial will test the feasibility of delivering bright light therapy (BLT) to patients undergoing ICB therapy. This trial asks participants to spend 60 minutes every morning receiving daily bright light therapy for at least 7 days prior to starting Immune Checkpoint blockade-containing regimens (e.g. anti-PD-1 and/or anti-CTLA-4 alone or in combination with chemotherapy). The bright light therapy will be delivered via the Circadian OS iPad application. There is evidence that a person's circadian rhythm can affect the response to immunotherapy. The circadian rhythm is a natural, internal process that regulates the sleep-wake cycle. Many patients with cancer have disrupted circadian rhythms and it's possible that disrupted circadian rhythms decrease the likelihood of responding to immunotherapy. The idea is to use bright light therapy, delivered via the Circadian OS iPad application, for an hour in the morning to synchronize your circadian rhythm for a week before your planned immunotherapy. The investigators hope that this will increase the likelihood of a response to immunotherapy, however in this study, the investigators are mainly concerned with whether the bright light therapy is tolerable to patients.

Conditions

Melanoma (Skin Cancer); NSCLC (Non-small Cell Lung Cancer)

Keywords

IIT BLT; Bright Light Therapy; Circadian; Circadian Rhythm

Outcome Measures

Primary Outcomes (1)

• Proportion of participants who completed ≥70% BLT sessions, with a minimum of 7 consecutive days of monitoring.

  The intervention will be considered feasible if ≥70% of patients achieve ≥70% adherence to the prescribed BLT sessions. Adherence will be automatically recorded via the Circadian OS iPad application using device-based monitoring of screen-on duration and light exposure data.

  Baseline through the day prior to Immune-Checkpoint Blockade administration (expected to be approximately 1-3 weeks).

Secondary Outcomes (2)

• Number of Participants with Adverse Events (AEs)

  Baseline through first Immune-Checkpoint Blockade administration (expected to be approximately 1-3 weeks).

• Proportion of Participants with Adverse Events (AEs)

  Baseline through first Immune-Checkpoint Blockade administration (expected to be approximately 1-3 weeks).

Study Arms (1)

Single-arm: adherence to 60 mins of daily Bright Light Therapy for >7 days prior to ICB initiation

EXPERIMENTAL

Device: Bright Light Therapy

Interventions

Bright Light Therapy DEVICE

Bright light therapy (BLT) will be delivered via the Circadian OS iPad application in patients with melanoma and NSCLC receiving first-line ICB-containing regimens (e.g. anti-PD-1 and/or anti-CTLA-4 alone or in combination with chemotherapy). CS is a unit designed to model melatonin suppression in order to measure how effective a light source is at stimulating the body's circadian system, based on light intensity, duration, and angle of delivery. CS will be delivered through the Circadian OS application. 60 minutes of BLT for \>7 days was chosen as an appropriate duration based on prior studies. With this stimulus, the goal is to entrain patients' circadian rhythm phase and amplitude to deliver ICB at peak immune function.

Single-arm: adherence to 60 mins of daily Bright Light Therapy for >7 days prior to ICB initiation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥18 years.
• Histologically confirmed diagnosis of advanced, unresectable melanoma or NSCLC.
• Presence of measurable tumor burden.
• 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).
• ECOG performance status 0-2.
• Able to provide informed consent.
• Access to reliable internet connection via WiFi or personal hotspot

You may not qualify if:

• Previous exposure to immune checkpoint blockade.
• Pregnant or breastfeeding.
• Use of melatonin or pharmacologic sleep aids (e.g., zolpidem, trazodone, benzodiazepines) within 14 days prior to enrollment.
• Diagnosis of bipolar disorder or history of mania or hypomania.
• Active psychosis, suicidal ideation, or recent psychiatric hospitalization (\<3 months).
• Poorly controlled seizures.
• Chronotype classified as extremely early or extremely late, based on the Munich Chronotype Questionnaire (MSFsc \< 2:00 or \> 5:00).
• Night shift work within the past 30 days or expected during the intervention.
• Travel across ≥2 time zones within the past 14 days.
• Diagnosed or suspected untreated moderate to severe obstructive sleep apnea.
• Migraine with photophobia.
• 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).

Sponsors & Collaborators

• Weill Medical College of Cornell University: lead
• Circadian OS: collaborator

Study Sites (1)

Weill Cornell Medicine

New York, New York, 10021, United States

Location

Related Publications (23)

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MeSH Terms

Conditions

Melanoma; Carcinoma, Non-Small-Cell Lung

Interventions

Ultraviolet Therapy

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Phototherapy; Therapeutics

Study Officials

• Paul Chapman, MD

  Weill Medical College of Cornell University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

June Greenberg, BSN, RN, OCN, CCRP, CCRC

CONTACT

212-746-2651; jdg2002@med.cornell.edu

Daniella Topol, RN

CONTACT

dat7032@med.cornell.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 17, 2026
• First Posted: June 22, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: June 26, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)