A Platform Study of Novel Agents in Combination With Radiotherapy in NSCLC
ConditionNon Small Cell Lung Cancer
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Leeds
About this trial
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 criteria
Qualifiers
Histologically or cytologically confirmed NSCLC (patients where the local MDT agree the diagnosis is NSCLC after review of the available pathology and imaging at MDT can be enrolled after discussion with the CI).
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) as part of treatment plan (either with or without induction chemotherapy).
Disqualifiers
Mixed non-small cell and small cell tumours.
Confirmed progressive disease during induction chemotherapy.
Participation in a study of an investigational agent or using an investigational device within 4 weeks prior to the anticipated start of treatment.
Current or previous malignant disease which may impact on a patient's estimated life expectancy (other than NSCLC).
Trial design
Treatments tested in this trial
- Radiotherapy
- Olaparib Oral Tablet [Lynparza]
- AZD1390
- Ceralasertib
- AZD5305
- Durvalumab
Treatment groups
200 Participants
are divided into 7 treatment groups7
Treatment groupsSee each treatment group below.
Sponsors and collaborators
University of Leeds
Lead sponsor
University of Manchester
Collaborator
Newcastle University
Collaborator
University of Oxford
Collaborator
The Leeds Teaching Hospitals NHS Trust
Collaborator
Beatson West of Scotland Cancer Centre
Collaborator
University of Glasgow
Collaborator
Velindre NHS Trust
Collaborator
University College London Hospitals
Collaborator
Queen's University, Belfast
Collaborator
University of Sheffield
Collaborator
Source ClinicalTrials.gov