CI

At a glance

ClinicalIndex Comparison Record
Phase 1Recruiting· 200 target
Drug / intervention
Olaparib Oral Tablet [Lynparza] +5 moredrug
Likely dose
Durvalumab 1500mgfrom record
Key inclusion· 9
  • ✓Histologically or cytologically confirmed NSCLC
  • ✓Not suitable for concurrent chemoradiotherapy/surgery due to tumour or patient factors
  • ✓Stage IIB and III (TNM 8th Edition)
  • ✓Planned to receive RT at curative intent doses (i.e., 60Gy)
Key exclusion· 22
  • ✕Mixed non-small cell and small cell tumours
  • ✕Progressive disease during induction chemotherapy
  • ✕Participation in investigational agent/device study within 4 weeks prior
  • ✕Other malignant disease impacting life expectancy

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

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NCT04550104Phase 1RecruitingMonitorUpdated 6mo ago · Completion was 4mo ago
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A Platform Study of DNA Damage Response Inhibitors in Combination With Conventional Radiotherapy in Non Small Cell Lung Cancer

University of Leeds·interventional·Posted Sep 16, 2020·Updated Dec 19, 2025

In Brief

A Phase 1 clinical trial evaluating Radiotherapy, Olaparib Oral Tablet [Lynparza], and 4 other interventions for Non Small Cell Lung Cancer. Currently recruiting, targeting 200 participants across 14 sites.

Signals

Enrolling slower than its timeline implies

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNon Small Cell Lung Cancer
CountriesUnited Kingdom
CollaboratorsUniversity 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

Timeline

Phase 1Recruiting
20212022202320242025202620272028
First PostedSep 16, 2020
Enrollment StartMar 17, 2021
Primary CompletionMar 1, 2026
Study CompletionMar 1, 2028
TodayJul 2, 2026
Enrollment to primary: 5.0 yearsPosted 5.8 years ago

Interventions

Radiotherapyradiation

Administered as 30 fractions of 2Gy. Total 60 60Gy. Administered once daily monday to friday.

Olaparib Oral Tablet [Lynparza]drug

Oral tablet

AZD1390drug

Oral tablet

Ceralasertibdrug

Oral Tablet

AZD5305drug

Oral Tablet

Durvalumabdrug

1500mg iv infusion