PD-L1 Expression in Lung Cancer

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)

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).

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

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