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Trial record 1 of 1 for:    NCT04992715
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PD-L1 Expression in Lung Cancer (PELICAN)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04992715
Recruitment Status : Recruiting
First Posted : August 5, 2021
Last Update Posted : March 22, 2023
Sponsor:
Collaborators:
Guy's and St Thomas' NHS Foundation Trust
King's College London
Information provided by (Responsible Party):
NanoMab Technology (UK) Limited

Study Description
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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).

Condition or disease Intervention/treatment Phase
Non-Small Cell Lung Cancer Diagnostic Test: [99mTc]-NM01 SPECT/CT Phase 2

Detailed Description:
A non-blinded, single centre, single interventional arm Phase II diagnostic imaging study.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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)
Actual Study Start Date : May 3, 2022
Estimated Primary Completion Date : September 2023
Estimated Study Completion Date : September 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Arms and Interventions
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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)


Outcome Measures
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Primary Outcome Measures :
  1. PD-L1 Expression Assessment using [99mTc]-NM-01 SPECT/CT [ Time Frame: Day 0 ]
    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 :
  1. Safety of [99mTc]-NM-01 SPECT/CT assessed through incidence of Adverse Drug Reactions [ Time Frame: Up to 12 days post-injection ]
    To assess the safety of [99mTc]-NM-01 SPECT/CT scan by observing for Adverse Drug Reactions (ADRs) occurring during the trial.

  2. PD-L1 expression heterogeneity as assessed by [99mTc]-NM-01 SPECT/CT tumour to blood-pool ratios in each lesion [ Time Frame: Day 0 ]
    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).


Other Outcome Measures:
  1. Exploratory Objectives [ Time Frame: Up to 16 weeks post-injection ]
    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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04992715


Contacts
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Contact: Gary JR Cook (0044)20 7188 7188 ext 88378 gary.cook@kcl.ac.uk
Contact: Honghoi Ting hhting@nano-mab.com

Locations
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United Kingdom
Guy's and St Thomas' NHS Foundation Trust Recruiting
London, United Kingdom
Contact: Gary JR Cook         
Sponsors and Collaborators
NanoMab Technology (UK) Limited
Guy's and St Thomas' NHS Foundation Trust
King's College London
Investigators
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Principal Investigator: Gary JR Cook Guy's and St Thomas' NHS Foundation Trust | King's College London, London, UK
More Information
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Publications:

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Responsible Party: NanoMab Technology (UK) Limited
ClinicalTrials.gov Identifier: NCT04992715    
Other Study ID Numbers: PELICAN
2020-002809-26 ( EudraCT Number )
First Posted: August 5, 2021    Key Record Dates
Last Update Posted: March 22, 2023
Last Verified: March 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by NanoMab Technology (UK) Limited:
PD-L1 Expression
Immunohistochemistry
SPECT/CT Imaging
Molecular Imaging
Heterogeneity
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
 Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms