Non Small Cell Lung CancerLIFENCT06107608
Molecular Imaging of FAP Expressing Cancer-associated Fibroblasts in NSCLC Treated With Immune-checkpoint Inhibitors
A study testing FAPI PET/CT in people with Non Small Cell Lung Cancer, run by Jules Bordet Institute at 1 site in Belgium.
Trial summary
Evaluation of the relation between baseline fibroblast activation protein (FAP) expression based on Ga-FAPI uptake with patient outcome among NSCLC patients receiving immunotherapy for recurrent/metastatic disease. 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?
- FAPI PET/CT
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteBelgium
- Study dates
- 13 Jun 2023to 1 Dec 2027
- Phase
- Interventional
- 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
Who may be able to join
- Age above 18 years.
- Pathologically- proven non-small-cell lung cancer (NSCLC).
- Proposed for treatment with anti-PD-(L)1 alone or in combination with chemotherapy and/or anti-CTLA4 in the advanced setting.
- ECOG Performance status ≤2.
- Patient's written informed consent obtained prior to any study procedure.
Who cannot join
- Surgery and/or radiotherapy to thoracic region within the last 8 weeks or anti-cancer systemic therapy within the last 2 weeks.
- Epidermal growth factor receptor (EGFR), anaplastic lymphoma kinase (ALK) and c-ros oncogene (ROS1) mutations.
- Pregnant and lactating women
- Previous or concurrent malignancy diagnosed within the last 2 years except adequately treated in situ carcinoma of the cervix uteri, localised (T1N0) low grade (Gleason score 6) prostate cancer undergoing active surveillance and basal or squamous cell skin cancer.
- Subjects with another significant medical condition which, in the investigator's opinion, may interfere with the completion of the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Belgium1 site, 1 recruiting
- Recruiting
Institut Jules Bordet
Brussels, 1070
Loubna Taraji Schiltz, +32 (0) 2 541 37 81, loubna.taraji@hubruxelles.be
About this study
Evaluation of the relation between baseline fibroblast activation protein (FAP) expression based on Ga-FAPI uptake with patient outcome among NSCLC patients receiving immunotherapy for recurrent/metastatic disease.
Read the detailed description
Fibroblast activation protein (FAP), a type II membrane glycoprotein, is selectively expressed by cancer-associated fibroblasts (CAFs) in more than 90% of epithelial carcinomas. FAP also regulates antitumor immune response. For these reasons, FAP is an attractive target and molecular imaging biomarker to assess CAFs and the tumour's landscape before and during immunotherapy. The PET radiotracer 68Ga-FAPI (Fibroblast activation protein inhibitor) allows the visualisation and quantification of CAFs.This study will use a non-invasive technique to assess CAFs before and during immunotherapy and to evaluate diverse predictive biomarkers in a prospective setting studying simultaneously CAFs (using 68Ga-FAPI) and cfDNA.
- Conditions
- Non Small Cell Lung Cancer
- Being tested
- FAPI PET/CT
- Keywords
- Immunotherapy, FAPI-46, Non Small Cell Lung Cancer, PET, PET/CT, fibroblast activation protein, fibroblast activation protein inhibitor
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FAPI PET/CTProcedure or surgery
The radiopharmaceutical 68Gallium-FAPI-46 (FAPI) is injected intravenously for molecular imaging of FAP expression with FAPI PET/CT.
| Study group | Role | What they receive |
|---|---|---|
| FAPI PET/CT | Experimental | The radiopharmaceutical 68Gallium-FAPI-46 (FAPI) is injected intravenously for molecular imaging of FAP expression with FAPI PET/CT in patients with NSCLC with an indication for immunotherapy Receives: Procedure: FAPI PET/CT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression free survival
Patient outcome assessed by progression-free survival (PFS) defined as the time from the start of immunotherapy until disease progression* or death by any cause during the period of active and routine follow-up (overall PFS)
Measured: From date of inclusion until the date of first documented progression (RECIST) or date of death from any cause, whichever came first, assessed up to 24 months
Secondary outcomes (4)
Overall survival
Patient outcome assessed by 0verall survival (OS) defined as the time from the start of immunotherapy until death by any cause.
Measured: until death by any cause, assessed up to 24 months
Objective response rate
Patient outcome assessed by objective response rate based on iRECIST criteria
- Kinetics of imaging biomarkers assessed with 68Ga-FAPI PET/CT at baseline and during treatment - examples of kinetics of imaging biomarkers: ΔSUVmax / ΔSUVpeak / ΔUptake-Volume.
Measured: From date of inclusion until the date of first documented progression (RECIST) or date of death from any cause, whichever came first, assessed up to 24 months
cfDNA
Kinetics of cfDNA values at baseline and during treatment
Measured: From date of inclusion until the date of last FAPI PET/CT (6 weeks after start immunotherapy)
Number of lesions
Number of metastatic lesions and the imaging biomarkers (SUVmax / SUVpeak / Uptake-Volume / Tumour-to-Background ratio) of the lesions on 68Ga-FAPI PET/CT and 18F-FDG PET/CT
Measured: From date of inclusion until the date of first documented progression (RECIST) or date of death from any cause, whichever came first, assessed up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2023
- Study start13 Jun 2023
- Primary completion1 Jul 2027 (estimated)
- Study completion1 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- molecular imaging of FAP
- Masking
- None (open label)
- Enrolment
- 58 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jules Bordet Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06107608
- Sponsor's protocol ID
- IJB-MN-LIFE1
- Acronym
- LIFE
- Status last verified
- Mar 2025
- First submitted
- 26 Sep 2023
- Last updated
- 31 Mar 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Molecular Imaging of FAP Expressing Cancer-associated Fibroblasts in NSCLC Treated With Immune-checkpoint Inhibitors
- ClinicalTrials.gov ID
- NCT06107608
- Acronym / sponsor ID
- LIFE / IJB-MN-LIFE1
- Conditions
- Non Small Cell Lung Cancer
- Keywords
- Immunotherapy, FAPI-46, Non Small Cell Lung Cancer, PET, PET/CT, fibroblast activation protein, fibroblast activation protein inhibitor
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 58 participants (estimated)
- Lead sponsor
- Jules Bordet InstituteUniversity, hospital or other
- Study start
- 13 Jun 2023 (actual)
- Primary completion
- 1 Jul 2027 (estimated)
- Study completion
- 1 Dec 2027 (estimated)
- First posted
- 30 Oct 2023 (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.
Evaluation of the relation between baseline fibroblast activation protein (FAP) expression based on Ga-FAPI uptake with patient outcome among NSCLC patients receiving immunotherapy for recurrent/metastatic disease.
Detailed description
Fibroblast activation protein (FAP), a type II membrane glycoprotein, is selectively expressed by cancer-associated fibroblasts (CAFs) in more than 90% of epithelial carcinomas. FAP also regulates antitumor immune response. For these reasons, FAP is an attractive target and molecular imaging biomarker to assess CAFs and the tumour's landscape before and during immunotherapy. The PET radiotracer 68Ga-FAPI (Fibroblast activation protein inhibitor) allows the visualisation and quantification of CAFs.This study will use a non-invasive technique to assess CAFs before and during immunotherapy and to evaluate diverse predictive biomarkers in a prospective setting studying simultaneously CAFs (using 68Ga-FAPI) and cfDNA.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- molecular imaging of FAP
| Arm | Type | Receives |
|---|---|---|
| FAPI PET/CT | Experimental | Procedure: FAPI PET/CTThe radiopharmaceutical 68Gallium-FAPI-46 (FAPI) is injected intravenously for molecular imaging of FAP expression with FAPI PET/CT in patients with NSCLC with an indication for immunotherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age above 18 years.
- Pathologically- proven non-small-cell lung cancer (NSCLC).
- Proposed for treatment with anti-PD-(L)1 alone or in combination with chemotherapy and/or anti-CTLA4 in the advanced setting.
- ECOG Performance status ≤2.
- Patient's written informed consent obtained prior to any study procedure.
Key exclusion criteria (5 listed)
- Surgery and/or radiotherapy to thoracic region within the last 8 weeks or anti-cancer systemic therapy within the last 2 weeks.
- Epidermal growth factor receptor (EGFR), anaplastic lymphoma kinase (ALK) and c-ros oncogene (ROS1) mutations.
- Pregnant and lactating women
- Previous or concurrent malignancy diagnosed within the last 2 years except adequately treated in situ carcinoma of the cervix uteri, localised (T1N0) low grade (Gleason score 6) prostate cancer undergoing active surveillance and basal or squamous cell skin cancer.
- Subjects with another significant medical condition which, in the investigator's opinion, may interfere with the completion of the study.
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 |
|---|---|---|
| FAPI PET/CTThe radiopharmaceutical 68Gallium-FAPI-46 (FAPI) is injected intravenously for molecular imaging of FAP expression with FAPI PET/CT. | Procedure or surgery | FAPI PET/CT |
Primary outcome
Progression free survival
Time frame: From date of inclusion until the date of first documented progression (RECIST) or date of death from any cause, whichever came first, assessed up to 24 months
Patient outcome assessed by progression-free survival (PFS) defined as the time from the start of immunotherapy until disease progression* or death by any cause during the period of active and routine follow-up (overall PFS)
4 secondary outcomes
Overall survival
Time frame: until death by any cause, assessed up to 24 months
Objective response rate
Time frame: From date of inclusion until the date of first documented progression (RECIST) or date of death from any cause, whichever came first, assessed up to 24 months
cfDNA
Time frame: From date of inclusion until the date of last FAPI PET/CT (6 weeks after start immunotherapy)
Number of lesions
Time frame: From date of inclusion until the date of first documented progression (RECIST) or date of death from any cause, whichever came first, assessed up to 24 months
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 31 Mar 2025.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FAPI PET/CT in people with Non Small Cell Lung Cancer, run by Jules Bordet Institute at 1 site in Belgium.
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 5 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 31 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression free survival (time frame: From date of inclusion until the date of first documented progression (RECIST) or date of death from any cause, whichever came first, assessed up to 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 31 Mar 2025.