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Trial Title:
PD-L1 Expression in Lung Cancer
NCT ID:
NCT04992715
Condition:
Non-Small Cell Lung Cancer
Conditions: Official terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Conditions: Keywords:
PD-L1 Expression
Immunohistochemistry
SPECT/CT Imaging
Molecular Imaging
Heterogeneity
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Diagnostic
Masking:
None (Open Label)
Intervention:
Intervention type:
Diagnostic Test
Intervention name:
[99mTc]-NM01 SPECT/CT
Description:
Technetium-99m radiolabelled anti-PD-L1 single-domain antibody (NM01) single-photon
emission computed tomography (SPECT)/computed tomography (CT)
Arm group label:
Metastatic Non-Small Cell Lung Cancer
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.
Criteria for 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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Guy's and St Thomas' NHS Foundation Trust
Address:
City:
London
Country:
United Kingdom
Status:
Recruiting
Contact:
Last name:
Gary JR Cook
Start date:
May 3, 2022
Completion date:
September 2023
Lead sponsor:
Agency:
NanoMab Technology (UK) Limited
Agency class:
Industry
Collaborator:
Agency:
Guy's and St Thomas' NHS Foundation Trust
Agency class:
Other
Collaborator:
Agency:
King's College London
Agency class:
Other
Source:
NanoMab Technology (UK) Limited
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT04992715
