Ireland
--:--IST
Starting soon Observational

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

NCT06738680 · tracked via the Priya Life Science France tracker
Phase
Observational
Started
2025-01-30
Last updated
2024-12-18

Condition(s) studied

Non-Small Cell Lung Cancer

Investigational drug(s) / intervention(s)

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

LAFOV system (an innovative, latest-generation system) scan: To collect data from the LAFOV system (an innovative, latest-generation system) during the PET scan planned as part of your treatment.

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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 outcome measure(s)

  • 1-year Progression-Free Survival — From date of chemo-immunotherapy initiation until the date of first documented progression or date of death, assessed up to 100 months.
    The primary endpoint is 1-year Progression-Free Survival (PFS) rate. PFS is defined as the time from chemo-immunotherapy initiation to the date of the first documented event of tumor progression or death in the absence of disease progression, whichever came first, assessed up to 100 months.

Trial sites (2)

FacilityCityRegionStatus
Brest University Hospital Brest France
Morlaix Hospital Center Morlaix France
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06738680 on ClinicalTrials.gov ↗ ← All trials in France