Developing Circulating and Imaging Biomarkers Towards Personalised Radiotherapy in Lung Cancer

Status: Recruiting
Location: See location...
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
United Kingdom
The Christie NHS Foundation Trust
RECRUITING
Manchester
Time Frame
Start Date: 2023-03-24
Estimated Completion Date: 2025-09-24
Participants
Target number of participants: 80
Treatments
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.
Related Therapeutic Areas
Sponsors
Leads: University of Manchester
Collaborators: Cancer Research UK

This content was sourced from clinicaltrials.gov