A Platform Study of Novel Agents in Combination With Radiotherapy in NSCLC

CONCORDE is a multi-institution, multi-arm, Phase IB study that will determine the recommended phase II dose (RP2D) and safety profiles of different DNA damage repair inhibitors (DDRis) when given in an open label fashion in combination with fixed dose curative intent radiotherapy (RT) in patients with stage IIB/IIIA/IIIB NSCLC, followed by up to 12 months of consolidation durvalumab immunotherapy in selected study arms. The RP2D will be evaluated by incorporating the number of observed dose limiting toxicities (DLTs) into a time to event continuous reassessment method (TiTE- CRM) model within each of the experimental arms. TiTE-CRM is used here to take into account longer-term toxicities up to 13.5 months post start of radiotherapy and use these to inform dose escalation decision making.

NCT Number	NCT04550104
Lead Sponsor	University of Leeds Collaborators: University of Manchester, Newcastle University, University of Oxford, The Leeds Teaching Hospitals NHS Trust, Beatson West of Scotland Cancer Centre, University of Glasgow, Velindre NHS Trust, University College London Hospitals, Queen's University, Belfast, University of Sheffield
Conditions	Non Small Cell Lung Cancer
Enrollment	200 participants
Start Date	2021-03-17
Primary Completion	2026-03 (estimated)
Study Completion	2028-03 (estimated)
Updated on ClinicalTrials.gov	2025-12-19