RecruitingPhase 1NCT04550104

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


Sponsor

University of Leeds

Enrollment

200 participants

Start Date

Mar 17, 2021

Study Type

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing novel agents combined with radiation therapy in patients with non-small cell lung cancer (NSCLC) who are not suitable for surgery or standard combined chemoradiation. It uses a platform approach, meaning multiple treatment combinations can be tested under one master protocol. **You may be eligible if...** - You are 18 or older with confirmed non-small cell lung cancer (NSCLC) - Your cancer is stage IIB or III (locally advanced, but not yet widely spread) - You are not a suitable candidate for surgery or concurrent chemoradiation due to your tumor location or overall health - You are planned to receive radiation therapy at a curative dose (60 Gy) - If you received prior chemotherapy, the last dose was within 10 weeks of starting radiation **You may NOT be eligible if...** - You have widely metastatic (stage IV) disease - Your overall health is too poor for radical radiation therapy - You have significant uncontrolled medical conditions Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

RADIATIONRadiotherapy

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

DRUGOlaparib Oral Tablet [Lynparza]

Oral tablet

DRUGAZD1390

Oral tablet

DRUGCeralasertib

Oral Tablet

DRUGAZD5305

Oral Tablet

DRUGDurvalumab

1500mg iv infusion


Locations(14)

Belfast City Hospital

Belfast, United Kingdom

Birmingham Heartlands Hospital

Birmingham, United Kingdom

Addenbrooke's Hospital

Cambridge, United Kingdom

Velindre Cancer Centre

Cardiff, United Kingdom

The Royal Marsden Hospital Chelsea

Chelsea, United Kingdom

Western General Hospital

Edinburgh, United Kingdom

St James's University Hospital

Leeds, United Kingdom

The Clatterbridge Cancer Centre

Liverpool, United Kingdom

St Bartholomew's Hospitals

London, United Kingdom

University College Hospital London

London, United Kingdom

The Christie NHS Foundation Trust

Manchester, United Kingdom

Freeman Hospital, Newcastle upon Tyne Hospitals NHS Trust

Newcastle upon Tyne, United Kingdom

Weston Park Hospital

Sheffield, United Kingdom

The Royal Marsden Sutton

Sutton, United Kingdom

View Full Details on ClinicalTrials.gov

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NCT04550104