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

University of Manchester

Status: Enrolling

Conditions: Lung Cancer Stage III

Study type: Observational

Funder types: Other

Identifiers

NCT06086574

299279 (Other Identifier)

NHS001986

22/NW/0297 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 80 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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.

Trial design

80 participants in 1 patient group

Patients diagnosed with stage 3 NSCLC

Description:

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.