Developing Circulating and Imaging Biomarkers Towards Personalised Radiotherapy in Lung Cancer

Lung Cancer Stage III Clinical Trial

— VIGILANCE  

Official title:

Developing Circulating and Imaging Biomarkers Towards Personalised Radiotherapy in Lung Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06086574
• Other study ID #: NHS001986
• Secondary ID: 29927922/NW/0297
• Status: Recruiting
• Start date: March 24, 2023
• Est. completion date: September 24, 2025

Study information

• Verified date: October 2023
• Source: University of Manchester
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

In stage 3 NSCLC, treatment and follow-up are generally performed in a 'one-size-fits-all' manner. In the setting of metastatic lung cancer there has been considerable success identifying biomarkers, which allow treatments to be tailored and lead to more personalised medicine. In patients with stage 3 disease there exists a significant unmet clinical need for equivalent biomarkers to guide treatment decisions such as to identify poor responders, predict benefit from treatment and diagnose relapse before standard of care imaging. Recent advances have made it possible to detect and quantify circulating-tumour DNA in peripheral blood of patients with stage 3 NSCLC, a promising prognostic biomarker and a measure of minimal residual disease. In addition, the information contained in routine medical images and electronic patient reported outcome measure (ePROM) questionnaires can add further predictive power to circulating tumour DNA and other clinical factors to determine patient's outcome. There is scope to integrate biomarkers in treatment decision algorithms aiming to make personalised treatment modifications (e.g. decision to treat with immunotherapy or not). VIGILANCE is a highly exploratory observational study to understand how these biomarkers might inform a future hypothesis driven interventional study.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: September 24, 2025
• Est. primary completion date: September 24, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion criteria:

• Histological or cytologically confirmed NSCLC.
• Unsuitable for surgery due to tumour or patient factors.
• Stage 3 A, B or C (TNM version 8).
• Planned to receive radical radiotherapy OR sequential chemoradiotherapy OR concurrent chemoradiotherapy +/- consolidation immunotherapy.
• Predicted life expectancy >12 weeks.
• Ability to provide written informed consent.
• Willingness to comply with study procedures.

Exclusion criteria:

• Mixed non-small cell and small cell tumours.
• Adjuvant radiotherapy post-surgery.
• Participation in a study of an interventional study as part of lung cancer treatment.
• Recent/active malignant disease which might impact study results.
• Psychotic disorders/cognitive impairment.

Related Conditions & MeSH terms

• Lung Cancer Stage III
• Lung Neoplasms

Locations

Country	Name	City	State
United Kingdom	The Christie NHS Foundation Trust	Manchester

Sponsors (2)

Lead Sponsor	Collaborator
University of Manchester	Cancer Research UK

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prognostic model built using baseline and longitudinal circulating-tumour DNA, radiomic features and patient reported measures to predict survival, tumour control and early tumour relapse.		2.5 years
Secondary	Longitudinal description of circulating-tumour DNA patterns at baseline, during and for up to 1 year following completion of radiotherapy.		2.5 years
Secondary	Longitudinal description of radiomic features at baseline, during and for up to 1 year following completion of radiotherapy.		2.5 years
Secondary	Longitudinal description of patient reported outcomes at baseline, during and for up to 1 year following completion of radiotherapy.		2.5 years
Secondary	Predictive model built using baseline and longitudinal circulating-tumour DNA and radiomic features to predict benefit from consolidation immunotherapy.		2.5 years
Secondary	Associations between features and changes in features over time will be described, e.g. radiomic features associated with circulating-tumour DNA and radiomic features.		2.5 years