Non-Small Cell Lung CancerPROFIL-1NCT06738680
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
An observational study of Non-Small Cell Lung Cancer, run by University Hospital, Brest at 2 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-Small Cell Lung Cancer
- What is being tested?
- LAFOV system (an innovative, latest-generation system) scan
- How many people
- 120 participants
- Where
- 2 sitesFrance
- Study dates
- 30 Jan 2025to 2 Nov 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France2 sites
Brest University Hospital
Brest, 29609
Margaux GEIER, +33230338030, margaux.geier@chu-brest.fr
Ronan ABGRAL, +33298223069, ronan.abgral@chu-brest.fr
Morlaix Hospital Center
Morlaix, 29600
Karim AMRANE, +33298626038, KAmrane@ch-morlaix.fr
Karim AMRANE
About this study
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
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.
Read the 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.
- Conditions
- Non-Small Cell Lung Cancer
- Being tested
- LAFOV system (an innovative, latest-generation system) scan
- Keywords
- Chemo-immunotherapy, Non-Small Cell Lung Cancer, Metastatic, Imaging Biomarkers, Prediction of response
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LAFOV system (an innovative, latest-generation system) scanDiagnostic test
To collect data from the LAFOV system (an innovative, latest-generation system) during the PET scan planned as part of your treatment.
What is being measured
The primary outcome is the main question the study is designed to answer.
1-year Progression-Free Survival
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.
Measured: From date of chemo-immunotherapy initiation until the date of first documented progression or date of death, assessed up to 100 months.
Secondary outcomes (9)
Measurement of Ki images
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
Measured: From baseline PET/CT before chemo immunotherapy in ml/min/100 g
Measurement of distribution volume
Measurement of distribution volume dynamic PET/CT parameter based on direct and indirect Patlak reconstruction methods with PBIF or IDIF in LAFOV-PET from baseline PET/CT before chemo immunotherapy
Measured: From baseline PET/CT before chemo immunotherapy in L/kg
Correlation between quantitative dynamic and radiomic parameters and clinico-histopathological parameters
Correlation analyses between quantitative dynamic and radiomic PET derived parameters and clinico-histopathological parameters (clinical, biology, histology, genomic).
Measured: From baseline PET/CT before chemo immunotherapy
Contrast-to-noise ratio (CNR)
Contrast-to-noise ratio (CNR) (indicating the image quality in the lesion)
Measured: From baseline LAFOV PET/CT
Target-to-background ratio (TBR)
Target-to-background ratio (TBR), defined as the ratio of the lesions\&#39; SUVmax and the SUVmean of healthy liver tissue (background) determined for each reconstruction algorithm
Measured: From baseline LAFOV PET/CT
Objective response rate (ORR)
Objective response rate (ORR), defined as the proportion of patients experiencing an objective response (either complete response [CR] or partial response [PR]) as best response to CT-IO according to RECIST 1.1 criteria
Measured: From baseline LAFOV PET to end of 1 year of treatment
Metabolic response rate (MRR)
Metabolic response rate (MRR), defined as the proportion of patients experiencing a metabolic response (either complete metabolic response [CMR] or partial metabolic response [PMR]) as best response to CT-IO according to Positron Emission Tomography Response Criteria in Solid Tumors version 1.0 (PERCIST v1.0)
Measured: From baseline LAFOV PET to end of 1 year of treatment
Overall Survival
Overall Survival, defined as the time from chemo-immunotherapy initiation until the date of death from any cause, assessed up to 100 months
Measured: From date of chemo-immunotherapy initiation until the date of death from any cause, assessed up to 100 months
Safety
Safety and tolerability according to National Cancer Institute Common Terminology Criteria for Adverse Events, version 5.0.; Patient reported outcomes according to EQ-5D-5L and EORTC QLQ-C30 (baseline, 3 months, 6 months, 12 months).
Measured: From baseline LAFOV PET to end of 1 year of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2024
- Study start30 Jan 2025 (estimated)
- Primary completion30 Jan 2026 (estimated)
- Study completion2 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Non-Small Cell Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Margaux GEIER, Study director, University Hospital, Brest
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06738680
- Sponsor's protocol ID
- 29BRC24.0049
- Acronym
- PROFIL-1
- Status last verified
- Dec 2024
- First submitted
- 15 Nov 2024
- Last updated
- 18 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Geier 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.
PubMed 41931499
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06738680
- Acronym / sponsor ID
- PROFIL-1 / 29BRC24.0049
- Conditions
- Non-Small Cell Lung Cancer
- Keywords
- Chemo-immunotherapy, Non-Small Cell Lung Cancer, Metastatic, Imaging Biomarkers, Prediction of response
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Study start
- 30 Jan 2025 (estimated)
- Primary completion
- 30 Jan 2026 (estimated)
- Study completion
- 2 Nov 2026 (estimated)
- First posted
- 18 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LAFOV system (an innovative, latest-generation system) scanTo collect data from the LAFOV system (an innovative, latest-generation system) during the PET scan planned as part of your treatment. | Diagnostic test | – |
Primary outcome
1-year Progression-Free Survival
Time frame: 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.
9 secondary outcomes
Measurement of Ki images
Time frame: From baseline PET/CT before chemo immunotherapy in ml/min/100 g
Measurement of distribution volume
Time frame: From baseline PET/CT before chemo immunotherapy in L/kg
Correlation between quantitative dynamic and radiomic parameters and clinico-histopathological parameters
Time frame: From baseline PET/CT before chemo immunotherapy
Contrast-to-noise ratio (CNR)
Time frame: From baseline LAFOV PET/CT
Target-to-background ratio (TBR)
Time frame: From baseline LAFOV PET/CT
Objective response rate (ORR)
Time frame: From baseline LAFOV PET to end of 1 year of treatment
Metabolic response rate (MRR)
Time frame: From baseline LAFOV PET to end of 1 year of treatment
Overall Survival
Time frame: From date of chemo-immunotherapy initiation until the date of death from any cause, assessed up to 100 months
Safety
Time frame: From baseline LAFOV PET to end of 1 year of treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2024.
- Derived from this study: PubMed 41931499Geier 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Margaux GEIER study director
University Hospital, Brest
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Non-Small Cell Lung Cancer, run by University Hospital, Brest at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 18 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Margaux GEIER (+33230338030, margaux.geier@chu-brest.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
1-year Progression-Free Survival (time frame: From date of chemo-immunotherapy initiation until the date of first documented progression or date of death, assessed up to 100 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06738680, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2024.