Clinical trial · 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
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Non-Small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| LAFOV system (an innovative, latest-generation system) scan | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- 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.
- description
- 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.
Secondary outcomes (9)
- measure
- Measurement of Ki images
- timeFrame
- From baseline PET/CT before chemo immunotherapy in ml/min/100 g
- description
- Measurement of Ki images PET/CT parameters based on direct and indirect Patlak reconstruction methods with PBIF or IDIF in LAFOV-PET from baseline PET/CT before chemo immunotherapy
- measure
- Measurement of distribution volume
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDGeier M, Amrane K, Bourhis D, Le Roux PY, Nguyen J, Dhamelincourt E, Descourt R, Quere G, Guegan M, Besse B, Deandreis D, Besson F, Faure S, Karakatsanis N, Salaun PY, Pavoine M, Bourbonne V, Lucia F, Abgral R. PRognostic and predictive potential Of multiparametric dynamic whole-body 18F-FDG PET Imaging using a Long axial field-of-view (LAFOV) system for FIRST-line chemo-immunotherapy efficacy in advanced non-small cell lung cancer: PROFIL-1 study protocol. PLoS One. 2026 Apr 3;21(4):e0345990. doi: 10.1371/journal.pone.0345990. eCollection 2026. PMID 41931499