Molecular Imaging of FAP Expressing Cancer-associated Fibroblasts in NSCLC Treated With Immune-checkpoint Inhibitors
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Jules Bordet Institute
- Enrollment
- 58
- Locations
- 1
- Primary Endpoint
- Progression free survival
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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 ≤
- •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.
Arms & Interventions
FAPI PET/CT
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
Intervention: FAPI PET/CT (Procedure)
Outcomes
Primary Outcomes
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)
Secondary Outcomes
- Objective response rate(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(From date of inclusion until the date of last FAPI PET/CT (6 weeks after start immunotherapy))
- Number of lesions(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)
- Overall survival(until death by any cause, assessed up to 24 months)