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NCT Number: NCT06107608

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

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.

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Key information

Conditions

Non Small Cell Lung Cancer Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

FAPI PET/CT

Procedure

The radiopharmaceutical 68Gallium-FAPI-46 (FAPI) is injected intravenously for molecular imaging of FAP expression with FAPI PET/CT.

Primary outcomes

  1. 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

  1. Overall survival

    Time frame: until death by any cause, assessed up to 24 months

    Patient outcome assessed by 0verall survival (OS) defined as the time from the start of immunotherapy until death by any cause.

  2. Objective response rate

    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 objective response rate based on iRECIST criteria

    • Kinetics of imaging biomarkers assessed with 68Ga-FAPI PET/CT at baseline and during treatment - examples of kinetics of imaging biomarkers: ΔSUVmax / ΔSUVpeak / ΔUptake-Volume.

  3. cfDNA

    Time frame: From date of inclusion until the date of last FAPI PET/CT (6 weeks after start immunotherapy)

    Kinetics of cfDNA values at baseline and during treatment

  4. Number of lesions

    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

    Number of metastatic lesions and the imaging biomarkers (SUVmax / SUVpeak / Uptake-Volume / Tumour-to-Background ratio) of the lesions on 68Ga-FAPI PET/CT and 18F-FDG PET/CT

Sponsors and collaborators

Lead sponsor

Jules Bordet Institute

Other

Registry information

Acronym: LIFE

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Oct 30, 2023
Registry last updated
Mar 31, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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