Imaging cancer-associated fibroblasts in lung cancer patients receiving immunotherapy
Molecular Imaging of FAP Expressing Cancer-associated Fibroblasts in NSCLC Treated With Immune-checkpoint Inhibitors
This study is testing whether a special imaging technique can help doctors see how certain cells in lung cancer patients respond to immunotherapy and predict their treatment outcomes.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 58 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Jules Bordet Institute Academic / other |
| Drugs / interventions | chemotherapy, immunotherapy |
| Locations | 1 site (Brussels) |
| Trial ID | NCT06107608 on ClinicalTrials.gov |
What this trial studies
This study evaluates the relationship between fibroblast activation protein (FAP) expression and patient outcomes in individuals with non-small cell lung cancer (NSCLC) undergoing immunotherapy. Using the PET radiotracer 68Ga-FAPI, the study aims to visualize and quantify cancer-associated fibroblasts (CAFs) before and during treatment. The approach is non-invasive and seeks to identify predictive biomarkers that may enhance the understanding of tumor dynamics and patient response to therapy.
Who should consider this trial
Good fit: Ideal candidates include adults over 18 with pathologically-proven NSCLC who are set to receive anti-PD-(L)1 therapy, either alone or in combination with other treatments.
Not a fit: Patients with specific genetic mutations (EGFR, ALK, ROS1) or those who have had recent cancer treatments may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve the personalization of immunotherapy for lung cancer patients by identifying which individuals are more likely to benefit from treatment.
How similar studies have performed: While the use of FAP imaging in cancer is a growing area, this specific approach in NSCLC with immunotherapy is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Brussels
- Institut Jules Bordet — Brussels, Belgium (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.