2023 World Conference on Lung Cancer (Posters)-P2.01. An Update on the CONCORDE study: A Phase Ib Platform Study of Novel Agents in Combination With Conventional Radiotherapy in NSCLC

P2.01. An Update on the CONCORDE study: A Phase Ib Platform Study of Novel Agents in Combination With Conventional Radiotherapy in NSCLC - PDF(Slides)

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The CONCORDE study is a Phase Ib platform study that aims to assess the effectiveness and safety of novel agents in combination with conventional radiotherapy (RT) for patients with non-small cell lung cancer (NSCLC). The study is sponsored by the University of Leeds and funded by Cancer Research UK (CRUK) and AstraZeneca. The primary objective of the study is to determine the recommended phase II dose of each DNA damage response inhibitor (DDRi)RT combination and assess their safety.<br /><br />The study includes participants with inoperable stage IIB/IIIA/B/C NSCLC who are not suitable for concurrent chemoradiotherapy. Participants receive RT of 60Gy in 30 fractions over 6 weeks and are randomly assigned to one of five arms, with three of the arms also receiving up to 12 months of consolidation durvalumab/-DDRi. The study utilizes an adaptive Bayesian model-based approach to dose escalation.<br /><br />As of March 23, 2023, three arms of the study, CONCORDE-A (olaparib), CONCORDE-B (AZD1390), and CONCORDE-C (ceralasertib with consolidation durvalumab), are open to recruitment across 9 centers. So far, 46 participants have been registered, with 35 randomized and 33 starting treatment. Baseline characteristics of the participants show a median age of 74, with 59.6% male and a mix of squamous carcinoma and adenocarcinoma cases.<br /><br />No dose-limiting toxicities have been observed in the DDRi arms, while one has been observed in the RT-alone arm. Participants are followed up every six weeks and then every three months following completion of radiotherapy until 2 years post completion.<br /><br />The trial is ongoing, with one additional study arm (CONCORDE-F) planned and a parallel translational program being developed to identify biomarkers of treatment response, toxicity, and immune system impact. The biomarkers of interest include plasma toxicity markers, immune cell profiling, radiomics, and ctDNA.<br /><br />For further information, the clinical trial identifier for CONCORDE is NCT04550104, and the trials unit contact is ctru_concorde@leeds.ac.uk.

Asset Subtitle

Ashley Horne

Meta Tag

Speaker Ashley Horne

Topic Local-Regional NSCLC: Novel Therapies & Trials

Keywords

CONCORDE study

Phase Ib platform study

novel agents

conventional radiotherapy

non-small cell lung cancer

University of Leeds

DNA damage response inhibitor

dose escalation

biomarkers

clinical trial identifier