PRedictive Value of Multiparametric Dynamic WB 18F-FDG-PET Imaging on a LAFOV System for FIRST-line Chemo-immunotherapy Efficacy in Advanced Non-small-cell Lung Cancer: PROFIL-1

Lung cancer is the leading cause of cancer deaths worldwide. Revolution of chemo-immunotherapy (CT-IO) in first-line of metastatic non-small-cell lung cancers (NSCLC) without actionable genomic alterations (AGAs) has dramatically improved prognosis, providing long response to a subset of patients. Because of a highly heterogeneous disease, majority of patients do not show long term benefit. Long axial field of view positron emission tomography (LAFOV-PET) scanner is a new emerging system allowing dynamic whole-body imaging with higher sensitivity, representing unique opportunity for oncological applications. The aim of this study is to determine if LAFOV-PET imaging biomarkers could early predict response to CT-IO in NSCLC.

PROFIL-1 is a multicentre, single-arm, prospective non-interventional pilot study investigating the predictive value of multiparametric 18F-fluoro-deoxyglucose whole-body dynamic PET imaging on a LAFOV system for first-line CT-IO efficacy in advanced NSCLC, with a planned enrolment of 120 patients at 2 French sites. Adult patients with treatment-naïve advanced non-squamous or squamous NSCLC without AGAs and eligible for first-line CT-IO will be recruited for PROFIL-1. Patients will undergo LAFOV-PET before and after CT-IO induction. The primary objective is to evaluate predictive performance of a whole-body multiparametric analysis (radiomics and dynamics) in LAFOV-PET on CT-IO efficacy based on progression-free survival (PFS) per RECIST v1.1 by investigators. Secondary endpoints included correlations between imaging parameters and clinico-pathological characteristics, comparison between direct Patlak and indirect Patlak methods to determine dynamic parameters such as Ki (the net influx rate) and distribution volume (DV), number of tumor lesions and signal-to-noise ratio, objective response rate (ORR), overall survival (OS) and safety.

• Measurement of Ki images [Срок оценки: From baseline PET/CT before chemo immunotherapy in ml/min/100 g]
• Measurement of distribution volume [Срок оценки: From baseline PET/CT before chemo immunotherapy in L/kg]
• Correlation between quantitative dynamic and radiomic parameters and clinico-histopathological parameters [Срок оценки: From baseline PET/CT before chemo immunotherapy]
• Contrast-to-noise ratio (CNR) [Срок оценки: From baseline LAFOV PET/CT]
• Target-to-background ratio (TBR) [Срок оценки: From baseline LAFOV PET/CT]
• Objective response rate (ORR) [Срок оценки: From baseline LAFOV PET to end of 1 year of treatment]
• Metabolic response rate (MRR) [Срок оценки: From baseline LAFOV PET to end of 1 year of treatment]
• Overall Survival [Срок оценки: From date of chemo-immunotherapy initiation until the date of death from any cause, assessed up to 100 months]
• Safety [Срок оценки: From baseline LAFOV PET to end of 1 year of treatment]