Clinical trial • Phase IV • Oncology

[AL[18F]F]FAPI-74 for Non-small cell lung cancer

Phase IV trial of [AL[18F]F]FAPI-74 for Non-small cell lung cancer. None/Not specified-controlled. 60 participants.

Overview

Trial Therapeutic Area
Oncology
Trial Disease
Non-small cell lung cancer
Trial Stage
Phase IV
Drug Modality
Radiopharmaceutical

Key dates

Initial CTIS Submission Date
23-09-2025
First CTIS Authorization Date
16-12-2025

Trial design

None/Not specified-controlled Phase IV trial across 1 site in Finland.

Comparator
None/Not specified
Target Sample Size
60

Eligibility

Recruits 60 No vulnerable populations selected (isVulnerablePopulationSelected:false). Participants are adults (>18 years). Subject information and informed consent form documents are available..

Vulnerable Population
No vulnerable populations selected (isVulnerablePopulationSelected:false). Participants are adults (>18 years). Subject information and informed consent form documents are available.

Inclusion criteria

  • {"criterion_text":"- Diagnosis: Histologically confirmed adenocarcinoma or squamous cell carcinoma."}
  • {"criterion_text":"- Study 1: No previous treatment (surgical, radiotherapy or medical treatment) for NSCLC."}
  • {"criterion_text":"- Study 2: Lobectomy or stereotactical radiotherapy or chemoradiotherapy for NSCLC."}
  • {"criterion_text":"- Clinical stage: Study 1: Stage I-III, Age: > 18 yo."}

Exclusion criteria

  • {"criterion_text":"-\tInfections: Patient must not have an uncontrolled serious infection"}
  • {"criterion_text":"- \tno other malignancies"}
  • {"criterion_text":"- \tno known history of sarcoidosis"}
  • {"criterion_text":"-\tStudy 2: under six months after radiotherapy"}
  • {"criterion_text":"-\tPatient is not able to understand purpose of study"}
  • {"criterion_text":"-\tMedical conditions prohibiting whole body PET-CT"}

Endpoints

Primary endpoints

  • {"endpoint_text":"- SUVmax, SUVmean and SUVpeak of the primary tumor, tumor recurrence, lymph node metastasis or distant metastasis","definition_or_measurement_approach":"Measured by 18F-FAPI-74 PET/CT imaging (SUV metrics on PET/CT) as part of the study objective to explore feasibility of 18F-FAPI-74 PET/CT imaging."}

Secondary endpoints

  • {"endpoint_text":"- Histological confirmation of cancer in lesions with FAPI PET -imaging","definition_or_measurement_approach":"Histological confirmation (biopsy/pathology) of lesions identified on FAPI PET imaging."}

Recruitment

Planned Sample Size
60
Recruitment Window Months
38
Consent Approach
Informed consent to be obtained from adult participants. Subject information and informed consent form documents are listed in the trial documentation (e.g. 'Suostumuslomake v2'). No assent/parental consent described (participants are >18).

Geography

Total Number Of Sites
1
Total Number Of Participants
60

Finland

Earliest CTIS Part Ii Submission Date
29-09-2025
Latest Decision Or Authorization Date
16-12-2025
Processing Time Days
78
Number Of Sites
1
Number Of Participants
60

Sites

Site Name
Turku University Hospital
Department Name
Clinical Physiology and Nuclear Medicine
Principal Investigator Name
Jukka Kemppainen
Principal Investigator Email
jukka.kemppainen@varha.fi
Contact Person Name
Jukka Kemppainen
Contact Person Email
jukka.kemppainen@varha.fi
Number Of Participants
60

Sponsor

Primary sponsor

Full Name
Turku University Hospital
Organisation Type
Hospital/Clinic/Other health care facility
Country Of Registered Address
Finland

Investigational products

Investigational Product Name
[18F]FAPI-74
Active Substance
[AL[18F]F]FAPI-74
Modality
Radiopharmaceutical
Routes Of Administration
INTRAVENOUS INJECTION
Route
INTRAVENOUS INJECTION
Maximum Dose
400 MBq

Related trials

Other published trials that may interest you.