uPAR-PET for Prognostication in Patients With Non-small Cell Lung Cancer, Malignant Pleural Mesothelioma and Large Cell Neuroendocrine Carcinoma of the Lung

Study Overview
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Brief Summary
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uPAR PET/CT as a prognostic marker in non-small cell lung cancer.

Detailed Description
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Study I: uPAR PET/CT with 68Ga-NOTA-AE105 will be evaluated as a prognostic tool in patients with non-small cell lung cancer (NSCLC) (stage IV (Ia) operable disease (Ib)) by observer-blinded readings and compared to the prognostic performance of FDG PET/CT and prognostic biomarkers as uPAR. Furthermore, uPAR PET/CT will be evaluated in a pilot study in patients with malignant pleural mesothelioma (MPM) (Study II) and large cell neuroendocrine carcinoma of the lung (LCNEC) (Study III) and correlated with immunohistochemical uPAR expression.

Conditions
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Non-small Cell Lung Cancer, Malignant Pleural Mesothelioma, Large Cell Neuroendocrine Carcinoma of the Lung

Intervention / Treatment
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* Other: 68Ga-NOTA-AE105 PET/CT


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Study I Histologically verified NSCLC (Study I) Stage IV disease Operable disease The participants must be capable of understanding and giving full informed written consent Study II Histologically verified MPM (Study II) The participants must be capable of understanding and giving full informed written consent Study III Histologically verified LCNEC (Study III) The participants must be capable of understanding and giving full informed written consent Exclusion Criteria: Study I, II, III Pregnancy Lactation/breast feeding Treatment with neoadjuvant chemotherapy Weight above 140 kg Allergy to 68Ga-NOTA-AE105

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 68Ga-NOTA-AE105 PET/CT<br>One injection of 68Ga-NOTA-AE105 followed by positron emission tomography/computed tomography (PET/CT scan) will be performed before treatment start to evaluate the prognostic value of uPAR PET/CT. | Other: 68Ga-NOTA-AE105 PET/CT<br>* Following injection of 68Ga-NOTA-AE105 the patients will be subjected to PET/CT<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Study Ia: Overall survival (OS) |  | Study Ia: OS is evaluated after clinical follow-up for 18 months (stage IV disease) | 
| Study Ib: Overall survival (OS) |  | Study Ib: OS is evaluated after clinical follow-up for 60 months (operable disease) | 
| Study II and III: Uptake of 68Ga-NOTA-AE105 in primary tumor lesion (dichotomized +/-) |  | Study II and III: Uptake of 68Ga-NOTA-AE105 is evaluated based on PET/CT scans performed within 1 hour post injection of 68Ga-NOTA-AE105 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Study Ia: Progression free survival (PFS) |  | Study Ia: PFS is evaluated after clinical follow-up for 18 months (stage IV disease) | 
| Study Ib: Disease free survival (DFS) |  | Study Ib: DFS is evaluated after clinical follow-up for 60 months (operable disease) |