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PD-L1 Expression in Lung Cancer (PELICAN)

Primary Purpose

Non-Small Cell Lung Cancer

Status

Recruiting

Phase

Phase 2

Locations

United Kingdom

Study Type

Interventional

Intervention

[99mTc]-NM01 SPECT/CT

About this trial

This is an interventional diagnostic trial for Non-Small Cell Lung Cancer focused on measuring PD-L1 Expression, Immunohistochemistry, SPECT/CT Imaging, Molecular Imaging, Heterogeneity

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Guy's and St Thomas' NHS Foundation TrustRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Metastatic Non-Small Cell Lung Cancer

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

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).

Full Information

NCT ID

NCT04992715

First Posted

July 19, 2021

Last Updated

March 21, 2023

Sponsor

NanoMab Technology (UK) Limited

Collaborators

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

1. Study Identification

Unique Protocol Identification Number

NCT04992715

Brief Title

PD-L1 Expression in Lung Cancer

Acronym

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)

Study Type

Interventional

2. Study Status

Record Verification Date

March 2023

Overall Recruitment Status

Recruiting

Study Start Date

May 3, 2022 (Actual)

Primary Completion Date

September 2023 (Anticipated)

Study Completion Date

September 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

NanoMab Technology (UK) Limited

Collaborators

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

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Non-Small Cell Lung Cancer

Keywords

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

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

15 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Metastatic Non-Small Cell Lung Cancer

Arm Type

Experimental

Arm Description

Intervention Type

Diagnostic Test

Intervention Name(s)

[99mTc]-NM01 SPECT/CT

Intervention Description

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

Primary Outcome Measure Information:

Title

PD-L1 Expression Assessment using [99mTc]-NM-01 SPECT/CT

Description

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.

Time Frame

Day 0

Secondary Outcome Measure Information:

Title

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

Description

To assess the safety of [99mTc]-NM-01 SPECT/CT scan by observing for Adverse Drug Reactions (ADRs) occurring during the trial.

Time Frame

Up to 12 days post-injection

Title

PD-L1 expression heterogeneity as assessed by [99mTc]-NM-01 SPECT/CT tumour to blood-pool ratios in each lesion

Description

Time Frame

Day 0

Other Pre-specified Outcome Measures:

Title

Exploratory Objectives

Description

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.

Time Frame

Up to 16 weeks post-injection

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Gary JR Cook

Phone

(0044)20 7188 7188 ext 88378

gary.cook@kcl.ac.uk

First Name & Middle Initial & Last Name or Official Title & Degree

Honghoi Ting

hhting@nano-mab.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Gary JR Cook

Organizational Affiliation

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

Official's Role

Principal Investigator

Facility Information:

Facility Name

Guy's and St Thomas' NHS Foundation Trust

City

London

Country

United Kingdom

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Gary JR Cook

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

34234994

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.

Results Reference

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PubMed Identifier

30796165

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.

Results Reference

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PubMed Identifier

33259032

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.

Results Reference

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PD-L1 Expression in Lung Cancer

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