Developing Circulating and Imaging Biomarkers Towards Personalised Radiotherapy in Lung Cancer

NCT06086574 | Unknown DMC

• 3 other identifiers: NHS00198629927922/NW/0297
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Lung Cancer Stage III

Keywords

Non small cell lung cancer; NSCLC; Stage III; Radiotherapy; Biomarker; Circulating-tumour DNA; Radiomics; PROM

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• 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

Study Arms (1)

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.

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

Patients treated under The Christie NHS Foundation Trust, Greater Manchester

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Manchester: lead
• Cancer Research UK: collaborator

Study Sites (1)

The Christie NHS Foundation Trust

Manchester, United Kingdom

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Circulating-tumour DNA is collected for analysis

MeSH Terms

Conditions

Lung Neoplasms; Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Corinne Faivre-Finn

Study Record Dates

• First Submitted: September 28, 2023
• First Posted: October 17, 2023
• Study Start: March 24, 2023
• Primary Completion: September 24, 2024
• Study Completion: September 24, 2025
• Last Updated: October 17, 2023

Record last verified: 2023-10

Locations

GB (1)