Non-Small Cell Lung Cancer Clinical Trial
— PELICANOfficial 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)
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).
Status | Recruiting |
Enrollment | 15 |
Est. completion date | September 2023 |
Est. primary completion date | September 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Guy's and St Thomas' NHS Foundation Trust | London |
Lead Sponsor | Collaborator |
---|---|
NanoMab Technology (UK) Limited | Guy's and St Thomas' NHS Foundation Trust, King's College London |
United Kingdom,
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. — View 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. — View 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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Exploratory Objectives | 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. | Up to 16 weeks post-injection | |
Primary | 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. | Day 0 | |
Secondary | 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. | Up to 12 days post-injection | |
Secondary | 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). | Day 0 |
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