ITTACA (Immunotherapy Time Teller for Advanced Lung Cancer)

NCT07661251 | Not Yet Recruiting

• 2 other identifiers: SP25-26-02350991
• Study Type: observational
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

Immunotherapy is a relatively new treatment that uses patients' own immune systems to fight diseases, particularly cancers. Recent studies suggest that the effectiveness of immunotherapy in cancer treatment may depend on the time of day it is given. This observational study wants to explore this further by looking at the effectiveness of immunotherapy in lung cancer patients in relation to their circadian rhythms. A circadian rhythm is the body's natural internal clock that regulates sleep, wakefulness, hormones, temperature and other bodily functions. They are roughly 24 hours long and respond to environmental cues, such as light and dark. An individual's circadian rhythm can be described by their chronotype which is their natural inclination to sleep at certain times of the day. Some people are 'early birds' or 'larks' and others are 'night owls'. It is usually difficult to determine a person's chronotype. A new tool has been developed by Warwick University called 'TimeTeller'. This study will see if TimeTeller can provide a non-invasive, practical, accurate and clinically relevant method to find out a person's chronotype by investigating specific genes in a single hair follicle or cheek swab sample. The study also aims to explore if different chronotypes respond better to immunotherapy treatments. Furthermore, it will look at whether immunotherapy changes the circadian rhythm. The results of this study may lead to further research in the future to explore how the timing of immunotherapy can work better for each individual. Additionally, it may provide greater insight into the impact immunotherapy has on human body clocks.

Conditions

Non-Small Cell Lung Cancer

Keywords

Non-Small Cell Lung Cancer; Immunotherapy; Chronotherapy; Pembrolizumab; Atezolizumab; Nivolumab; Circadian rhythms; TimeTeller

Outcome Measures

Primary Outcomes (1)

• Is TimeTeller able to identify the molecular clock phase in patients with advanced NSCLC from analysis of hair samples/buccal mucosa in at least 75% of the participants?

  Feasibility of estimating circadian phase from hair follicles or buccal mucosa samples from 60 patients with advanced NSCLC before (Baseline) and after treatment (+ day 42) with immune checkpoint inhibitors.

Eligibility Criteria

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

Study Population

Eligible patients will be identified through normal clinical appointments at the Alaw Day Unit (Oncology) in Ysbyty Gwynedd, Bangor, North Wales.

You may qualify if:

• Histological diagnosis of NSCLC, stage IIIB-IV NSCLC, receiving pembrolizumab, atezolizumab and nivolumab (+/- chemotherapy) as, adjuvant, neoadjuvant or palliative treatment at Ysbyty Gwynedd
• WHO performance status (PS) \<2
• Full capacity
• No uncontrolled comorbidities
• Able to wear the biosensor bracelet
• Able to understand English

You may not qualify if:

• WHO PS \>2
• Uncontrolled comorbidities
• Lacking capacity
• Inability to wear biosensor bracelet
• Complete alopecia.

Sponsors & Collaborators

• Laura Longshaw: lead
• University of Warwick: collaborator

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Sponsor is BCUHB C/O L Longshaw, Deputy R&D Manager

Study Record Dates

• First Submitted: January 23, 2026
• First Posted: June 22, 2026
• Study Start: June 15, 2026
• Primary Completion (Estimated): April 1, 2028
• Study Completion (Estimated): April 1, 2028
• Last Updated: June 22, 2026

Record last verified: 2026-06