Status:

RECRUITING

Molecular Imaging of FAP Expressing Cancer-associated Fibroblasts in NSCLC Treated With Immune-checkpoint Inhibitors

Lead Sponsor:

Jules Bordet Institute

Conditions:

Non Small Cell Lung Cancer

Eligibility:

All Genders

18+ years

Phase:

NA

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/metas...

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 ant...

Eligibility Criteria

Inclusion

  • 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

  • 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.

Key Trial Info

Start Date :

June 13 2023

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

December 1 2027

Estimated Enrollment :

58 Patients enrolled

Trial Details

Trial ID

NCT06107608

Start Date

June 13 2023

End Date

December 1 2027

Last Update

March 31 2025

Active Locations (1)

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1

Institut Jules Bordet

Brussels, Belgium, 1070