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.
Keywords: ATM, Ataxia telangiectasia mutated; ATR, Ataxia telangiectasia and Rad3 related; CRT, Chemoradiotherapy; CT, Computed tomography; CTCAE, Common terminology criteria for adverse events; CTRad, Clinical and Translational Radiotherapy Research Working Group; Continual reassessment method; DDRi, DNA damage response inhibitor; DLT, Dose limiting toxicity; DNA damage repair inhibitor; 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; Non-small cell lung cancer; PARP, Poly (ADP-ribose) polymerase; PET, Positron emission tomography; PFS, Progression free survival; PROMs, Patient-reported outcome measures; Platform trial; RECIST, Response evaluation criteria in solid tumours; RP2D, Recommended phase II dose; RT, Radiotherapy; SACT, Systemic anti-cancer therapy; SRC, Safety review committee; Sequential chemoradiotherapy; TNM, Tumour node metastasis; TiTE-CRM, Time to event continual reassessment method; cfDNA, Cell-free DNA.
© 2020 The Authors. Published by Elsevier B.V. on behalf of European Society for Radiotherapy and Oncology.