2022 World Conference on Lung Cancer (ePosters)-EP05.01-007. CONCORDE - A Phase Ib Platform Study of Novel Agents in COmbinatioN with COnventional RaDiothErapy in Non-small Cell Lung Cancer (NSCLC)

EP05.01-007. CONCORDE - A Phase Ib Platform Study of Novel Agents in COmbinatioN with COnventional RaDiothErapy in Non-small Cell Lung Cancer (NSCLC)

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The CONCORDE study is a Phase Ib platform study that aims to evaluate the use of five DNA damage response inhibitors (DDRi) in combination with radiotherapy (RT) in patients with non-small cell lung cancer (NSCLC). The study, sponsored by the University of Leeds and funded by Cancer Research UK and AstraZeneca, is an open-label, randomized study involving multiple institutions. The goal of the study is to determine the safety and recommended phase II dose of each DDRi, as well as to assess the efficacy of combining RT with these inhibitors. <br /><br />The study plans to recruit approximately 210 patients from 13 centers in the UK, with 30 patients in each experimental arm and around 50-60 patients receiving RT alone. Patients eligible for the study must have stage IIB/IIIA/B/C NSCLC and be medically inoperable and not suitable for concurrent chemoradiotherapy. The primary endpoint of the study is to assess the safety and determine the recommended phase II dose of each DDRi, which will be the dose level at which it is estimated that 25% of patients will experience dose limiting toxicity during and up to 13.5 months following RT. <br /><br />In addition to the clinical trial, the study includes a parallel translational program that aims to utilize plasma toxicity markers, immune cell profiling, as well as radiomics and ctDNA analysis. This program will help identify toxicity and response biomarkers related to both RT and the novel radiosensitizers being evaluated in the study. <br /><br />As of July 4th, seven sites have opened and 20 patients have been randomized within the study. It is anticipated that more sites will open in the coming months, and additional study arms with the inclusion of the drug durvalumab are being prepared. Grant applications for the planned translational aims of the study are in progress. <br /><br />Overall, the CONCORDE study is a novel and comprehensive study that aims to investigate the combination of DDRi with RT in patients with NSCLC. The study incorporates correlative translational studies and patient reported outcomes, making it a robust and valuable platform for evaluating these novel treatment approaches.

Asset Subtitle

Gerard M Walls

Meta Tag

Speaker Gerard M Walls

Topic Locally Advanced Non-small Cell Lung Cancer - Chemoradiotherapy and Radiotherapy

Keywords

CONCORDE study

Phase Ib

DNA damage response inhibitors

radiotherapy

non-small cell lung cancer

safety

recommended phase II dose

clinical trial

translational program

toxicity biomarkers