Clinical trial NCT06738680: 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
Official title: PRedictive Value of Multiparametric Dynamic Whole-body 18F-FDG-PET Imaging on a LAFOV System for FIRST-line Chemo-immunotherapy Efficacy in Advanced Non-small-cell Lung Cancer: PROFIL-1 Study
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Non-Small Cell Lung Cancer
Keywords: Chemo-immunotherapy
Non-Small Cell Lung Cancer
Metastatic
Imaging Biomarkers
Prediction of response
Lead sponsor: University Hospital, Brest
Sponsor class: OTHER
First posted: 2024-12-18
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with unresectable locally advanced non-irradiable or metastatic NSCLC, whose files are presented to the thoracic oncology Multidisciplinary Team at the Brest University Hospital and the Morlaix University Hospital, and for whom chemo-immunotherapy is indicated as 1st line treatment.

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Adult patients ≥ 18 years
* With advanced, non-operable, non-radiatable or metastatic NSCLC
* Treatment-naïve patients
* Eligible for first-line chemo-immunotherapy (anti-PD-1)
* Written Non-objection
* Eligible for LAFOV FDG-PET less than 21 days before initiation of treatment

Exclusion Criteria:

* Minor patients \<18 years
* Oncogenic addiction targetable in 1st line: EGFR, ALK, ROS1, RET
* Pregnancy or breast-feeding
* Other histology than NSCLC
* Ineligible for first-line chemo-immunotherapy
* PET-FDG Scan contraindications
* Refusal to participate

Primary outcomes:
measure: 1-year Progression-Free Survival
timeFrame: From date of chemo-immunotherapy initiation until the date of first documented progression or date of death, assessed up to 100 months.
Secondary outcomes:
measure: Measurement of Ki images
timeFrame: From baseline PET/CT before chemo immunotherapy in ml/min/100 g
measure: Measurement of distribution volume
timeFrame: From baseline PET/CT before chemo immunotherapy in L/kg
measure: Correlation between quantitative dynamic and radiomic parameters and clinico-histopathological parameters
timeFrame: From baseline PET/CT before chemo immunotherapy
measure: Contrast-to-noise ratio (CNR)
timeFrame: From baseline LAFOV PET/CT
measure: Target-to-background ratio (TBR)
timeFrame: From baseline LAFOV PET/CT
measure: Objective response rate (ORR)
timeFrame: From baseline LAFOV PET to end of 1 year of treatment
measure: Metabolic response rate (MRR)
timeFrame: From baseline LAFOV PET to end of 1 year of treatment
measure: Overall Survival
timeFrame: From date of chemo-immunotherapy initiation until the date of death from any cause, assessed up to 100 months
measure: Safety
timeFrame: From baseline LAFOV PET to end of 1 year of treatment
Other outcomes:
Locations:
city: Brest
country: France
facility: Brest University Hospital
city: Morlaix
country: France
facility: Morlaix Hospital Center
Study officials:
affiliation: University Hospital, Brest
name: Margaux GEIER
role: STUDY_DIRECTOR
References: