Clinical trial NCT04992715: PD-L1 Expression in Lung Cancer
Official title: 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)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Non-Small Cell Lung Cancer
Keywords: PD-L1 Expression
Immunohistochemistry
SPECT/CT Imaging
Molecular Imaging
Heterogeneity
Lead sponsor: NanoMab Technology (UK) Limited
Sponsor class: INDUSTRY
Collaborators: name: Guy's and St Thomas' NHS Foundation Trust
name: King's College London
First posted: 2021-08-05
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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

Primary outcomes:
measure: PD-L1 Expression Assessment using [99mTc]-NM-01 SPECT/CT
timeFrame: Day 0
Secondary outcomes:
measure: Safety of [99mTc]-NM-01 SPECT/CT assessed through incidence of Adverse Drug Reactions
timeFrame: Up to 12 days post-injection
measure: PD-L1 expression heterogeneity as assessed by [99mTc]-NM-01 SPECT/CT tumour to blood-pool ratios in each lesion
timeFrame: Day 0
Other outcomes:
measure: Exploratory Objectives
timeFrame: Up to 16 weeks post-injection
Locations:
city: London
country: United Kingdom
facility: Guy's and St Thomas' NHS Foundation Trust
Study officials:
affiliation: Guy's and St Thomas' NHS Foundation Trust | King's College London, London, UK
name: Gary JR Cook
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wong NC, Cai Y, Meszaros LK, Biersack HJ, Cook GJ, Ting HH, Mottaghy FM. Preclinical development and characterisation of 99mTc-NM-01 for SPECT/CT imaging of human PD-L1. Am J Nucl Med Mol Imaging. 2021 Jun 15;11(3):154-166. eCollection 2021.
citation: Xing Y, Chand G, Liu C, Cook GJR, O'Doherty J, Zhao L, Wong NCL, Meszaros LK, Ting HH, Zhao J. Early Phase I Study of a 99mTc-Labeled Anti-Programmed Death Ligand-1 (PD-L1) Single-Domain Antibody in SPECT/CT Assessment of PD-L1 Expression in Non-Small Cell Lung Cancer. J Nucl Med. 2019 Sep;60(9):1213-1220. doi: 10.2967/jnumed.118.224170. Epub 2019 Feb 22.
citation: Hughes DJ, Chand G, Goh V, Cook GJR. Inter- and intraobserver agreement of the quantitative assessment of [99mTc]-labelled anti-programmed death-ligand 1 (PD-L1) SPECT/CT in non-small cell lung cancer. EJNMMI Res. 2020 Dec 1;10(1):145. doi: 10.1186/s13550-020-00734-x.