Clinical trial NCT06107608: Molecular Imaging of FAP Expressing Cancer-associated Fibroblasts in NSCLC Treated With Immune-checkpoint Inhibitors
Official title: Molecular Imaging of FAP Expressing Cancer-associated Fibroblasts in NSCLC Treated With Immune-checkpoint Inhibitors
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
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
Lead sponsor: Jules Bordet Institute
Sponsor class: OTHER
First posted: 2023-10-30
Enrollment: 58
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: molecular imaging of FAP
Primary purpose: DIAGNOSTIC

Brief 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.

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.

Primary outcomes:
measure: Progression free survival
timeFrame: 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:
measure: Overall survival
timeFrame: until death by any cause, assessed up to 24 months
measure: Objective response rate
timeFrame: 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
measure: cfDNA
timeFrame: From date of inclusion until the date of last FAPI PET/CT (6 weeks after start immunotherapy)
measure: Number of lesions
timeFrame: 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
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Institut Jules Bordet
Study officials:
References: