Health TrialsbyHealthPanel

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

ConditionNon Small Cell Lung Cancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorJules Bordet Institute

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

  • FAPI PET/CT

    Procedure/Surgery

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

Treatment groups

58 Participants
are divided into 1 treatment group
Group A: FAPI PET/CTExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Progression free survival

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)

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

Secondary outcomes

1

Overall survival

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

Time frame
until death by any cause, assessed up to 24 months
2

Objective response rate

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.

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
3

cfDNA

Kinetics of cfDNA values at baseline and during treatment

Time frame
From date of inclusion until the date of last FAPI PET/CT (6 weeks after start immunotherapy)
4

Number of lesions

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

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Jules Bordet Institute

Lead sponsor

Source ClinicalTrials.gov
Apply now