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

NCT06107608 | Recruiting

• 1 other identifier: IJB-MN-LIFE1
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

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.

Conditions

Non Small Cell Lung Cancer

Keywords

Immunotherapy; FAPI-46; Non Small Cell Lung Cancer; PET; PET/CT; fibroblast activation protein; fibroblast activation protein inhibitor

Outcome Measures

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)

  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 (4)

• Overall survival

  until death by any cause, assessed up to 24 months

• 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

Study Arms (1)

FAPI PET/CT

EXPERIMENTAL

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

Procedure: FAPI PET/CT

Interventions

FAPI PET/CT PROCEDURE

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

FAPI PET/CT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Jules Bordet Institute: lead

Study Sites (1)

Institut Jules Bordet

Brussels, 1070, Belgium

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: molecular imaging of FAP

Study Record Dates

• First Submitted: September 26, 2023
• First Posted: October 30, 2023
• Study Start: June 13, 2023
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: March 31, 2025

Record last verified: 2025-03

Locations

BE (1)