162TiP - An update on the VIGILANCE study: Developing circulating and imaging biomarkers towards personalised radiotherapy in lung cancer

Background

Multi-modality radiotherapy-based treatments are available to treat patients with stage III non-small cell lung cancer and are associated with improved clinical outcomes. However, not all patients benefit from these complex treatments and there is a paucity of biomarkers supporting treatment decisions tailored to the individual patient. The VIGILANCE study’s primary aim is to build a prognostic model using longitudinal novel health technology data collected before, during and for 1 year after completion of radiotherapy in patients with stage III non-small cell lung cancer. This includes blood samples for methylated circulating tumour DNA analysis, electronic patient reported outcome measures (ePROMs) and radiomic analysis of standard-of-care imaging. The study is sponsored by the University of Manchester and funded by CRUK, a Rosetree Grant and AstraZeneca.

Trial design

Key eligibility: Inoperable stage III NSCLC planned to be treated with either radical radiotherapy, sequential chemoradiotherapy and concurrent chemoradiotherapy +/- consolidation immunotherapy. Participants will have additional blood samples and ePROMs performed and their standard of care imaging will be acquired as per table. The VIGILANCE study opened to recruitment on 24^th March 2023 for 18 months. Up to 80 patients will be enrolled. As of 08/01/2024, 31 patients have been registered: 16 patients were treated with concurrent chemoradiotherapy, 5 patients with sequential chemoradiotherapy, 6 patients with radiotherapy alone, 1 patient died of a pneumonia prior to starting treatment, 1 patient progressed and was no longer ineligible and 2 patients withdrew their consent. The study continues to recruit.

Table: 162TiP

Study data collection

*includes diagnostic and radiotherapy planning CT and PET-CT **only in patients treated with concurrent chemoradiotherapy

Clinical trial identification

NCT06086574.

Legal entity responsible for the study

The University of Manchester, Manchester, UK.

Funding

AstraZeneca and Rosetree Charity.

Disclosure

All authors have declared no conflicts of interest.