PD-L1 Expression in Lung Cancer

Phase 2

Recruiting

• Conditions: Non-Small Cell Lung Cancer
• Interventions: Diagnostic Test: [99mTc]-NM01 SPECT/CT

• Registration Number: NCT04992715
• Lead Sponsor: NanoMab Technology (UK) Limited

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.

Study Timeline

• Study First Submitted: 2021-07-19
• Study First Submitted QC: 2021-07-29
• Study First Posted: 2021-08-05
• Study Start: 2022-05-03
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-21
• Last Update Posted: 2023-03-22
• Primary Completion: 2023-09
• Study Completion: 2023-09

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 15

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Metastatic Non-Small Cell Lung Cancer	[99mTc]-NM01 SPECT/CT	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.

Primary Outcome Measures

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

Name	Time	Method
Safety of [99mTc]-NM-01 SPECT/CT assessed through incidence of Adverse Drug Reactions	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.
PD-L1 expression heterogeneity as assessed by [99mTc]-NM-01 SPECT/CT tumour to blood-pool ratios in each lesion	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).

Trial Locations

Locations (1)

Guy's and St Thomas' NHS Foundation Trust; 🇬🇧 London, United Kingdom