A Platform Study of Novel Agents in Combination With Radiotherapy in NSCLC
Status:
Recruiting
Trial end date:
2027-05-01
Target enrollment:
Participant gender:
Summary
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. 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.
Phase:
Phase 1
Details
Lead Sponsor:
University of Leeds
Collaborators:
Beatson West of Scotland Cancer Centre Newcastle University Queen's University, Belfast The Leeds Teaching Hospitals NHS Trust University College London Hospitals University of Glasgow University of Manchester University of Oxford University of Sheffield Velindre NHS Trust