CONCORDE: A phase I platform study of novel agents in combination with conventional radiotherapy in non-small-cell lung cancer

Abstract

Lung cancer is the leading cause of cancer mortality worldwide and most patients are unsuitable for ‘gold standard’ treatment, which is concurrent chemoradiotherapy. CONCORDE is a platform study seeking to establish the toxicity profiles of multiple novel radiosensitisers targeting DNA repair proteins in patients treated with sequential chemoradiotherapy. Time-to-event continual reassessment will facilitate efficient dose-finding.

Abbreviations

ATM: Ataxia telangiectasia mutated

ATR: Ataxia telangiectasia and Rad3 related

cfDNA: Cell-free DNA

CRT: Chemoradiotherapy

CT: Computed tomography

CTCAE: Common terminology criteria for adverse events

CTRad: Clinical and Translational Radiotherapy Research Working Group

DDRi: DNA damage response inhibitor

DLT: Dose limiting toxicity

DNA: Deoxyribonucleic acid

DNA-PK: DNA-dependent protein kinase

ECOG: Eastern Cooperative Oncology Group

EORTC: European Organisation for Research and Treatment of Cancer

ICRU: International Commission on Radiation Units and Measurements

IMPs: Investigational medicinal products

LA: Locally advanced

MRC: Medical Research Council

NCRI: National Cancer Research Institute

NSCLC: Non-small cell lung cancer

PARP: Poly (ADP-ribose) polymerase

PET: Positron emission tomography

PFS: Progression free survival

PROMs: Patient-reported outcome measures

RECIST: Response evaluation criteria in solid tumours

RP2D: Recommended phase II dose

RT: Radiotherapy

SACT: Systemic anti-cancer therapy

SRC: Safety review committee

TiTE-CRM: Time to event continual reassessment method

TNM: Tumour node metastasis

Metadata

Item Type:	Article
Authors/Creators:	Walls, GM Oughton, JB https://orcid.org/0000-0002-2047-804X Chalmers, AJ Brown, S Collinson, F Forster, MD Franks, KN Gilbert, A Hanna, GG Hannaway, N Harrow, S Hinsley, S Murden, G https://orcid.org/0000-0003-3124-9389 Phillip, R https://orcid.org/0000-0002-9604-9276 Anderson, RJ Salem, A Sebag-Montefoire, D Shaw, P Twelves, CJ Walker, K Young, RJ Faivre-Finn, C Greystoke, A
Copyright, Publisher and Additional Information:	©2020 The Authors. Published by Elsevier B.V. on behalf of European Society for Radiotherapy and Oncology. This is an open access article under the CC BY license (http://creativecommons.org/licenses/by/4.0/).
Keywords:	Non-small cell lung cancer; Sequential chemoradiotherapy; DNA damage repair inhibitor; Platform trial; Continual reassessment method
Dates:	Accepted: 15 September 2020 Published (online): 22 September 2020 Published: 1 November 2020
Institution:	The University of Leeds
Depositing User:	Symplectic Publications
Date Deposited:	29 Sep 2020 10:16
Last Modified:	07 Oct 2020 10:40
Status:	Published
Publisher:	Elsevier
Identification Number:	10.1016/j.ctro.2020.09.006
Open Archives Initiative ID (OAI ID):	oai:eprints.whiterose.ac.uk:165836

CORE (COnnecting REpositories)

CONCORDE: A phase I platform study of novel agents in combination with conventional radiotherapy in non-small-cell lung cancer

Abstract

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