uPAR-PET for prognostication in patients with non-small cell lung cancer and large cell neuroendocrine carcinoma of the lung

Phase II trial: uPAR-PET for prognostication in patients with non-small cell lung cancer and large cell neuroendocrine carcinoma of the lung

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2015-005642-59-DK

Enrollment

Registered

2016-01-21

Start date

2016-02-23

Completion date

Unknown

Last updated

2025-09-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-small cell lung cancer and large cell neuroendocrine carcinoma of the lung MedDRA version: 21.1 Level: PT Classification code 10061873 Term: Non-small cell lung cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 20.0 Level: PT Classification code 10059518 Term: Pleural mesothelioma malignant System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 20.0 Level: PT

Interventions

Product Name: 68Ga-NOTA-AE105 Product Code: 68Ga-NOTA-AE105 Pharmaceutical Form: Concentrate and solvent for solution for injection INN or Proposed INN: 68Ga-NOTA-AE105 Current Sponsor code: 68Ga-NOTA

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Study I: - Histologically verified NSCLC - Operable disease - Age above 18 - The participants must be capable of understanding and giving full informed written consent Study II: - Histologically verified LCNEC - Age above 18 - The participants must be capable of understanding and giving full informed written consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 20 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 60

Exclusion criteria

Exclusion criteria: Study I and II: - Pregnancy - Lactation/breast feeding - Age above 85 years - Weight above 140 kg - Treatment with neoadjuvant chemotherapy - Allergy to 68Ga-NOTA-AE105

Design outcomes

Primary

Measure	Time frame
Main Objective: Study I: 68Ga-NOTA-AE105 PET/CT for prognostication in NSCLC - 68Ga-NOTA-AE105 PET/CT will be evaluated as a prognostic tool in patients with NSCLC by observer-blinded readings and compared to the prognostic performance of FDG-PET/CT and prognostic biomarkers as uPAR and tissue factor. Study II: 68Ga-NOTA-AE105 PET/CT for prognostication in LCNEC - The objective of this pilot study (10 patients) is to evaluate 68Ga-NOTA-AE105 PET/CT in patients with LCNEC and correlate the uptake with uPAR expression. ;Secondary Objective: Study I: To evaluate the expression of tissue factor as a prognostic marker in NSCLC;Primary end point(s): Study I: Primary end point: Overall survival (OS) Study II: Primary end point dichotomized: +/- uptake of 68Ga-NOTA-AE105 in primary tumor ;Timepoint(s) of evaluation of this end point: Study I: Primary end point is evaluated after clinical follow-up for 60 months Study II: Primary end point is evaluated from PET/CT scans performed within 1 hour post injection of 68Ga-NOTA-AE105	—

Measure

Time frame

Main Objective: Study I: 68Ga-NOTA-AE105 PET/CT for prognostication in NSCLC - 68Ga-NOTA-AE105 PET/CT will be evaluated as a prognostic tool in patients with NSCLC by observer-blinded readings and compared to the prognostic performance of FDG-PET/CT and prognostic biomarkers as uPAR and tissue factor. Study II: 68Ga-NOTA-AE105 PET/CT for prognostication in LCNEC - The objective of this pilot study (10 patients) is to evaluate 68Ga-NOTA-AE105 PET/CT in patients with LCNEC and correlate the uptake with uPAR expression. ;Secondary Objective: Study I: To evaluate the expression of tissue factor as a prognostic marker in NSCLC;Primary end point(s): Study I: Primary end point: Overall survival (OS) Study II: Primary end point dichotomized: +/- uptake of 68Ga-NOTA-AE105 in primary tumor ;Timepoint(s) of evaluation of this end point: Study I: Primary end point is evaluated after clinical follow-up for 60 months Study II: Primary end point is evaluated from PET/CT scans performed within 1 hour post injection of 68Ga-NOTA-AE105

—

Secondary

Measure	Time frame
Secondary end point(s): Study I: Disease free survival (DFS) and progression free survival (PFS) ;Timepoint(s) of evaluation of this end point: Study I: Secondary end point is evaluated after clinical follow-up for 60 months	—

Countries

Denmark

Contacts

Public ContactMalene Martini Clausen

Rigshospitalet, Department of Clinical Physiology, Nuclear Medicine and PET

malene.martini.clausen@regionh.dk004522524536

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026