PD-L1 Expression in Lung Cancer

Non-Small Cell Lung Cancer Clinical Trial

— PELICAN  

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04992715
• Other study ID #: PELICAN
• Secondary ID: 2020-002809-26
• Status: Recruiting
• Phase: Phase 2
• Start date: May 3, 2022
• Est. completion date: September 2023

Study information

• Verified date: March 2023
• Source: NanoMab Technology (UK) Limited
• Contact: Gary JR Cook
• Phone: (0044)20 7188 7188 ext 88378
• Email: gary.cook[@]kcl.ac.uk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Description:

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 15
• Est. completion date: September 2023
• Est. primary completion date: September 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-Small Cell Lung Cancer

Intervention

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)

Locations

Country	Name	City	State
United Kingdom	Guy's and St Thomas' NHS Foundation Trust	London

Sponsors (3)

Lead Sponsor	Collaborator
NanoMab Technology (UK) Limited	Guy's and St Thomas' NHS Foundation Trust, King's College London

Country where clinical trial is conducted

United Kingdom, 

References & Publications (3)

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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	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	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
Secondary	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