A Platform Study of Novel Agents in Combination With Radiotherapy in NSCLC
A Platform Study of DNA Damage Response Inhibitors in Combination With Conventional Radiotherapy in Non Small Cell Lung Cancer
University of Leeds
200 participants
Mar 17, 2021
INTERVENTIONAL
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, 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.
Eligibility
Plain Language Summary
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Interventions
Administered as 30 fractions of 2Gy. Total 60 60Gy. Administered once daily monday to friday.
Oral tablet
Oral tablet
Oral Tablet
Oral Tablet
1500mg iv infusion
Locations(14)
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NCT04550104