Who is sponsoring CONCORDE?

CONCORDE is sponsored by University of Leeds.

What condition does CONCORDE study?

CONCORDE studies Non Small Cell Lung Cancer.

What drugs are being tested in CONCORDE?

Interventions: Radiotherapy, Olaparib Oral Tablet [Lynparza], AZD1390, Ceralasertib, AZD5305, Durvalumab.

What is the status of CONCORDE?

CONCORDE is currently RECRUITING.

Last reviewed 2025-12-18 · How we verify

A Platform Study of DNA Damage Response Inhibitors in Combination With Conventional Radiotherapy in Non Small Cell Lung Cancer (CONCORDE)

NCT04550104 Phase 1 RECRUITING

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.

Details

Lead sponsor	University of Leeds
Phase	Phase 1
Status	RECRUITING
Enrolment	200
Start date	2021-03-17
Completion	2028-03

Conditions

Non Small Cell Lung Cancer

Interventions

Radiotherapy
Olaparib Oral Tablet [Lynparza]
AZD1390
Ceralasertib
AZD5305
Durvalumab

Primary outcomes

Dose limiting Toxicities — 13.5 months after start of radiotherapy
Dose-limiting toxicities (DLTs), within 13.5 months of starting radiotherapy, in order to establish the Recommended Phase II Dose (RP2D) of each DDRi-RT combination.

Countries

United Kingdom