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NCT Number: NCT07661966

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

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.

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Key information

Conditions

Melanoma (Skin Cancer) Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Diseases Lung Neoplasms Melanoma NSCLC (Non-small Cell Lung Cancer) Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Germ Cell and Embryonal Neoplasms, Nerve Tissue Neuroectodermal Tumors Neuroendocrine Tumors Nevi and Melanomas Respiratory Tract Diseases Respiratory Tract Neoplasms Skin Diseases Skin Neoplasms Skin and Connective Tissue Diseases Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Weill Cornell Medicine

New York, 10021, United States

Location contact

Anna Pavlick, DO

SUB_INVESTIGATOR

Ashish Saxena, MD

SUB_INVESTIGATOR

Christine Garcia, MD

SUB_INVESTIGATOR

Daniella Topol Topol

CONTACT

[email protected]

Jessica Palmer, MD

SUB_INVESTIGATOR

June Greenberg

CONTACT

[email protected]

(212)-746-2651

Paul Chapman, MD

PRINCIPAL_INVESTIGATOR

About this study

This is a pilot study evaluating the feasibility, safety, and biological effects of bright light therapy (BLT) delivered via the Circadian OS iPad application in patients with melanoma and non-small cell lung cancer (NSCLC) receiving first-line immune checkpoint blockade (ICB)-containing regimens.

This is a single-arm feasibility study of adherence to 60 minutes of daily BLT for >7 days prior to ICB initiation. The investigators aims to enroll patients with measurable tumor burden who plan to receive first line ICB-containing regimens (e.g. anti-PD-1 and/or anti-CTLA-4 alone or in combination with chemotherapy).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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).

Treatment and study plan

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.

Primary outcomes

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

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

    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.

Secondary outcomes

  1. Number of Participants with Adverse Events (AEs)

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

    This will include adverse events, serious adverse events, and unanticipated adverse device effects.

  2. Proportion of Participants with Adverse Events (AEs)

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

    This will include adverse events, serious adverse events, and unanticipated adverse device effects.

Study contacts

Contact information is provided by the study sponsor or research team.

Daniella Topol, RN

CONTACT

[email protected]

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

CONTACT

[email protected]

212-746-2651

Sponsors and collaborators

Lead sponsor

Weill Medical College of Cornell University

Other

Collaborators

  • Circadian OS, Inc

Registry information

Official study title

A Pilot Trial of Bright Light Therapy in Patients Receiving First Line Immune Checkpoint Blockade

Acronym: IIT BLT

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jun 22, 2026
Registry last updated
Jun 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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