PD-L1 Expression in Lung Cancer

NCT04992715 | Unknown Phase 2 DMC

• 2 other identifiers: PELICAN2020-002809-26
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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).

Conditions

Non-Small Cell Lung Cancer

Keywords

PD-L1 Expression; Immunohistochemistry; SPECT/CT Imaging; Molecular Imaging; Heterogeneity

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Safety of [99mTc]-NM-01 SPECT/CT assessed through incidence of Adverse Drug Reactions

  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

  Day 0

Other Outcomes (1)

• Exploratory Objectives

  Up to 16 weeks post-injection

Study Arms (1)

Metastatic Non-Small Cell Lung Cancer

EXPERIMENTAL

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

Interventions

[99mTc]-NM01 SPECT/CT DIAGNOSTIC_TEST

Technetium-99m radiolabelled anti-PD-L1 single-domain antibody (NM01) single-photon emission computed tomography (SPECT)/computed tomography (CT)

Metastatic Non-Small Cell Lung Cancer

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• NanoMab Technology (UK) Limited: lead
• Guy's and St Thomas' NHS Foundation Trust: collaborator
• King's College London: collaborator

Study Sites (1)

Guy's and St Thomas' NHS Foundation Trust

London, United Kingdom

RECRUITING

Related Publications (4)

• 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.

  PMID: 34234994 BACKGROUND

• 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.

  PMID: 30796165 BACKGROUND

• 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.

  PMID: 33259032 BACKGROUND

• Hughes DJ, Chand G, Johnson J, Bailey D, Adamson K, Goh V, Cook GJR. Inter-rater and intra-rater agreement of [99mTc]-labelled NM-01, a single-domain programmed death-ligand 1 (PD-L1) antibody, using quantitative SPECT/CT in non-small cell lung cancer. EJNMMI Res. 2023 May 31;13(1):51. doi: 10.1186/s13550-023-01002-4.

  PMID: 37256434 DERIVED

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Gary JR Cook

  Guy's and St Thomas' NHS Foundation Trust | King's College London, London, UK

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gary JR Cook

CONTACT

(0044)20 7188 7188 ext 88378; gary.cook@kcl.ac.uk

Honghoi Ting

CONTACT

hhting@nano-mab.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 19, 2021
• First Posted: August 5, 2021
• Study Start: May 3, 2022
• Primary Completion: September 1, 2023
• Study Completion: September 1, 2023
• Last Updated: March 22, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)