PD-L1 Expression in Lung Cancer (PELICAN)

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).

Study Overview

• Status: Recruiting
• Conditions: Non-Small Cell Lung Cancer
• Intervention / Treatment: Diagnostic test: [99mTc]-NM01 SPECT/CT

Detailed Description

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

• Study Type: Interventional
• Enrollment (Anticipated): 15
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Gary JR Cook; Phone Number: (0044)20 7188 7188 ext 88378; Email: gary.cook@kcl.ac.uk
• Study Contact Backup: Name: Honghoi Ting; Email: hhting@nano-mab.com

Study Locations

• United Kingdom
  • London, United Kingdom
    • Recruiting
    • Guy's and St Thomas' NHS Foundation Trust
    • Contact: Gary JR Cook

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Metastatic Non-Small Cell Lung Cancer; 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; Technetium-99m radiolabelled anti-PD-L1 single-domain antibody (NM01) single-photon emission computed tomography (SPECT)/computed tomography (CT)

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Exploratory Objectives	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.	Up to 16 weeks post-injection

Collaborators and Investigators

• Sponsor: NanoMab Technology (UK) Limited
• Collaborators: King's College London; Guy's and St Thomas' NHS Foundation Trust
• Investigators: Principal Investigator: Gary JR Cook, Guy's and St Thomas' NHS Foundation Trust | King's College London, London, UK

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): May 3, 2022
• Primary Completion (Anticipated): September 1, 2023
• Study Completion (Anticipated): September 1, 2023

Study Registration Dates

• First Submitted: July 19, 2021
• First Submitted That Met QC Criteria: July 29, 2021
• First Posted (Actual): August 5, 2021

Study Record Updates

• Last Update Posted (Actual): March 22, 2023
• Last Update Submitted That Met QC Criteria: March 21, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: Heterogeneity; Immunohistochemistry; Molecular Imaging; PD-L1 Expression; SPECT/CT Imaging
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
• Other Study ID Numbers: PELICAN; 2020-002809-26 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No