PD-L1 Expression in Lung Cancer

Study Overview
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Brief Summary
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This study will measure PD-L1 expression in metastatic NSCLC (primary tumour and metastatic lesions) using [99mTc]-NM-01 SPECT/CT and compare to PD-L1 percentage expression determined by immunohistochemistry (IHC).

Detailed Description
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A non-blinded, single centre, single interventional arm Phase II diagnostic imaging study.

Official Title
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A Single-arm, Phase II Study to Evaluate PD-L1 Expression in Non-Small Cell Lung Cancer Using the 99mTc Labelled Anti-PD-L1 Single Domain Antibody (NM-01)

Conditions
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Non-Small Cell Lung Cancer

Intervention / Treatment
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* Diagnostic Test: [99mTc]-NM01 SPECT/CT


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Aged 18 or above Patients with histopathology confirmed untreated metastatic NSCLC scheduled for systemic anti-cancer therapy ECOG status ≤ 1 Willingness and ability to comply with scheduled study visits and tests Exclusion Criteria: Pregnant or breast-feeding women Concomitant uncontrolled medical conditions as per Investigator assessment > 3 months between IHC PD-L1 and study recruitment Significant abnormality of haematology (one or more of: Hb ≤ 90g/L, absolute neutrophil count (ANC) ≤1.5 x109/L, platelet count ≤75 x109/L) Significant abnormality of renal function (defined as Cockcroft-Gault calculated creatinine clearance ≤30 mL/min) Significant abnormality of liver function (one or more of: AST or ALT ≥2.5x ULN or ≥ 5x ULN if patient has liver metastases; total bilirubin ≥1.5xULN. In the case of patients with Gilbert's syndrome then direct bilirubin must be confirmed as ≤ ULN) Significant cardiovascular disease, including New York Heart Association (NYHA) heart failure ≥Class III, myocardial infarction within 3 months of enrolment, unstable arrhythmia or unstable angina History of uncontrolled allergic reactions and/or have hypersensitivity to anti-PD-L1 monoclonal antibodies, kanamycin A or aminoglycoside therapies, or other excipients that may induce hypersensitivity

Ages Eligible for Study
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Minimum Age: 18 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

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Metastatic Non-Small Cell Lung Cancer<br>Subjects with metastatic non-small cell lung cancer will be recruited as per protocol inclusion/exclusion criteria and will undergo [99mTc]-anti-PDL1 single-domain antibody ([99mTc]-NM-01) SPECT/CT imaging. [99mTc]-NM-01 SPECT/CT images will be compared to immunohistochemistry PD-L1 expression results. | Diagnostic Test: [99mTc]-NM01 SPECT/CT<br>* Technetium-99m radiolabelled anti-PD-L1 single-domain antibody (NM01) single-photon emission computed tomography (SPECT)/computed tomography (CT)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PD-L1 Expression Assessment using [99mTc]-NM-01 SPECT/CT | To measure PD-L1 expression in NSCLC (primary tumour and metastatic lesions) as assessed using [99mTc]-NM-01 SPECT/CT and compare to PD-L1 expression determined by IHC. | Day 0 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety of [99mTc]-NM-01 SPECT/CT assessed through incidence of Adverse Drug Reactions | To assess the safety of [99mTc]-NM-01 SPECT/CT scan by observing for Adverse Drug Reactions (ADRs) occurring during the trial. | Up to 12 days post-injection | 
| PD-L1 expression heterogeneity as assessed by [99mTc]-NM-01 SPECT/CT tumour to blood-pool ratios in each lesion | To measure intra-tumoural heterogeneity in the primary tumour, as well as in individual metastases and inter-tumoural heterogeneity between different disease sites (including different metastatic sites and between primary tumour and its metastases). | Day 0 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PD-L1 Expression, Immunohistochemistry, SPECT/CT Imaging, Molecular Imaging, Heterogeneity