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

ClinicalTrials.gov ID

NCT06738680

Lead Sponsor

University Hospital, BrestOTHER

Overall Status

Not yet recruiting

Study Type

Observational

Enrollment

120Estimated

Last Update Posted

Dec 18, 2024Actual

Start Date

Jan 30, 2025Estimated

Primary Completion Date

Jan 30, 2026Estimated

Completion Date

Nov 2, 2026Estimated

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

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.

• Non-Small Cell Lung Cancer

• LAFOV system (an innovative, latest-generation system) scan

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

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

Observational Model

Case-Only

Time Perspective

Prospective

Lead Sponsor

University Hospital, BrestOTHER

KAmrane@ch-morlaix.fr+33298626038

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