A Platform Study of Novel Agents in Combination With Radiotherapy in NSCLC
NCT04550104 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 200
Last updated 2025-12-19
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.
Conditions
- Non Small Cell Lung Cancer
Interventions
- RADIATION
-
Radiotherapy
Administered as 30 fractions of 2Gy. Total 60 60Gy. Administered once daily monday to friday.
- DRUG
-
Olaparib Oral Tablet [Lynparza]
Oral tablet
- DRUG
-
AZD1390
Oral tablet
- DRUG
-
Ceralasertib
Oral Tablet
- DRUG
-
AZD5305
Oral Tablet
- DRUG
-
1500mg iv infusion
Sponsors & Collaborators
-
University of Manchester
collaborator OTHER -
Newcastle University
collaborator OTHER -
University of Oxford
collaborator OTHER -
The Leeds Teaching Hospitals NHS Trust
collaborator OTHER -
Beatson West of Scotland Cancer Centre
collaborator UNKNOWN -
University of Glasgow
collaborator OTHER -
Velindre NHS Trust
collaborator OTHER_GOV -
University College London Hospitals
collaborator OTHER -
Queen's University, Belfast
collaborator OTHER -
University of Sheffield
collaborator OTHER -
University of Leeds
lead OTHER
Principal Investigators
-
Alastair Greystoke, MB ChB, MSc, PhD · Newcastle University
-
Corinne Faivre-Finn, MD, PhD · University of Manchester
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2021-03-17
- Primary Completion
- 2026-03-31
- Completion
- 2028-03-31
Countries
- United Kingdom
Study Locations
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