To hear about similar clinical trials, please enter your email below
Trial Title:
Molecular Imaging of FAP Expressing Cancer-associated Fibroblasts in NSCLC Treated With Immune-checkpoint Inhibitors
NCT ID:
NCT06107608
Condition:
Non Small Cell Lung Cancer
Conditions: Official terms:
Carcinoma, Non-Small-Cell Lung
Conditions: Keywords:
Immunotherapy
FAPI-46
Non Small Cell Lung Cancer
PET
PET/CT
fibroblast activation protein
fibroblast activation protein inhibitor
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Diagnostic
Masking:
None (Open Label)
Intervention:
Intervention type:
Procedure
Intervention name:
FAPI PET/CT
Description:
The radiopharmaceutical 68Gallium-FAPI-46 (FAPI) is injected intravenously for molecular
imaging of FAP expression with FAPI PET/CT.
Arm group label:
FAPI PET/CT
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.
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Institut Jules Bordet
Address:
City:
Brussels
Zip:
1070
Country:
Belgium
Status:
Recruiting
Contact:
Last name:
Loubna Taraji Schiltz
Phone:
+32 (0) 2 541 37 81
Email:
loubna.taraji@hubruxelles.be
Start date:
June 13, 2023
Completion date:
December 1, 2027
Lead sponsor:
Agency:
Jules Bordet Institute
Agency class:
Other
Source:
Jules Bordet Institute
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06107608
