Non-Small Cell Lung Cancer
Conditions
Keywords
PD-L1 Expression, Immunohistochemistry, SPECT/CT Imaging, Molecular Imaging, Heterogeneity
Brief summary
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
A non-blinded, single centre, single interventional arm Phase II diagnostic imaging study.
Interventions
DIAGNOSTIC_TEST[99mTc]-NM01 SPECT/CT
Technetium-99m radiolabelled anti-PD-L1 single-domain antibody (NM01) single-photon emission computed tomography (SPECT)/computed tomography (CT)
Sponsors
Guy's and St Thomas' NHS Foundation Trust
King's College London
NanoMab Technology (UK) Limited
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| PD-L1 Expression Assessment using [99mTc]-NM-01 SPECT/CT | Day 0 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Safety of [99mTc]-NM-01 SPECT/CT assessed through incidence of Adverse Drug Reactions | Up to 12 days post-injection | To assess the safety of \[99mTc\]-NM-01 SPECT/CT scan by observing for Adverse Drug Reactions (ADRs) occurring during the trial. |
| PD-L1 expression heterogeneity as assessed by [99mTc]-NM-01 SPECT/CT tumour to blood-pool ratios in each lesion | Day 0 | 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). |
Other
| Measure | Time frame | Description |
|---|---|---|
| Exploratory Objectives | Up to 16 weeks post-injection | To correlate the SPECT/CT PD-L1 assessment with other diagnostic parameters such as blood tumour mutation burden test and to detect the presence of anti-drug antibodies to \[99mTc\]-NM-01. |
Countries
United Kingdom
Contacts
Primary ContactGary JR Cook
Backup ContactHonghoi Ting
Outcome results
None listed