VIGILANCE: Developing Circulating and Imaging Biomarkers Towards Personalised Radiotherapy in Lung Cancer

Sponsor

University of Manchester (Other)

Overall Status

Recruiting

CT.gov ID

NCT06086574

Collaborator

Cancer Research UK (Other)

Enrollment

Location

30.1

Anticipated Duration (Months)

2.7

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Lung Cancer Stage III

Study Design

Study Type:

Observational

Anticipated Enrollment :

80 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Developing Circulating and Imaging Biomarkers Towards Personalised Radiotherapy in Lung Cancer

Actual Study Start Date :

Mar 24, 2023

Anticipated Primary Completion Date :

Sep 24, 2024

Anticipated Study Completion Date :

Sep 24, 2025

Arms and Interventions

Arm	Intervention/Treatment
Patients diagnosed with stage 3 NSCLC Patients will receive standard of care curative-intent radiotherapy treatment as decided by their primary oncologist. This includes radical radiotherapy, sequential chemoradiotherapy and concurrent chemoradiotherapy +/- consolidation immunotherapy. No changes in treatment. Patients will have data collected at baseline, during radiotherapy and for one year following radiotherapy. This longitudinal collection will include blood for circulating-tumour DNA analysis, electronic PROMS and radiomic analysis of standard of care imaging.

Arm

Intervention/Treatment

Patients diagnosed with stage 3 NSCLC

Patients will receive standard of care curative-intent radiotherapy treatment as decided by their primary oncologist. This includes radical radiotherapy, sequential chemoradiotherapy and concurrent chemoradiotherapy +/- consolidation immunotherapy. No changes in treatment. Patients will have data collected at baseline, during radiotherapy and for one year following radiotherapy. This longitudinal collection will include blood for circulating-tumour DNA analysis, electronic PROMS and radiomic analysis of standard of care imaging.

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

Longitudinal description of circulating-tumour DNA patterns at baseline, during and for up to 1 year following completion of radiotherapy. [2.5 years]
Longitudinal description of radiomic features at baseline, during and for up to 1 year following completion of radiotherapy. [2.5 years]
Longitudinal description of patient reported outcomes at baseline, during and for up to 1 year following completion of radiotherapy. [2.5 years]
Predictive model built using baseline and longitudinal circulating-tumour DNA and radiomic features to predict benefit from consolidation immunotherapy. [2.5 years]
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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.