PD-L1 Expression in Lung Cancer

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-05-03

Study Completion Date

2023-09-30

Brief Summary

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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).

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Detailed Description

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

Conditions

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Non-Small Cell Lung Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

[99mTc]-NM01 SPECT/CT

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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[99mTc]-NM01 SPECT/CT

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No