PD-L1 Expression in Cancer (PECan Study).

Conditions

Melanoma, Non-small Cell Lung Cancer

Keywords

immunotherapy, checkpoint inhibitors, molecular imaging, non-small cell lung cancer, melanoma

Brief summary

Measurement of PD-L1 expression in cancer to monitor treatment response. A prospective non-blinded, single centre, single interventional arm diagnostic imaging study. To determine the baseline level and variability within and between patients and tumour types of PD-L1 expression in melanoma and non-small cell lung cancer in immunotherapy naïve patients using \[99mTc\]-anti-PD-L1 SPECT/CT and immunohistochemistry.

Detailed description

Using \[99mTc\]-labeled anti-PD-L1 single-domain antibody, this study aims to prospectively measure changes in PD-L1 expression determined with SPECT/CT imaging and correlate these changes with response to anti-PD(L)1 immunotherapy.

Hughes DJ, Chand G, Johnson J, Tegala R, Bailey D, Adamson K, Edmonds S, Meszaros LK, Moore AEB, Manickavasagar T, Ndagire S, Gennatas S, Georgiou A, Ghosh S, Josephs D, Karapanagiotou E, McLean E, Ting HH, Spicer J, Goh V, Cook GJR.

2025-04-052 citations

10.1038/s41416-025-02991-w

The effects of anti-PD-1 therapy on programmed death-ligand 1 expression and glucose metabolism of normal organs in patients with advanced non-small cell lung cancer

Matthew Severyn, E. Lee, Gitasha Chand, Jessica Johnson, Damion Bailey et al. (9 authors)

BJR|Open2024-12-27

10.1093/bjro/tzaf010

Inter-rater and intra-rater agreement of [<sup>99m</sup>Tc]-labelled NM-01, a single-domain programmed death-ligand 1 (PD-L1) antibody, using quantitative SPECT/CT in non-small cell lung cancer.

Hughes DJ, Chand G, Johnson J, Bailey D, Adamson K, Goh V, Cook GJR.

2023-05-315 citations

10.1186/s13550-023-01002-4

[99mTc]-labelled anti-Programmed Death-Ligand 1 single-domain antibody SPECT/CT: a novel imaging biomarker for myocardial PD-L1 expression

Muhummad Sohaib Nazir, D.J. Hughes, Gitasha Chand, Kathryn Adamson, Jessica Johnson et al. (18 authors)

EJNMMI Research2023-05-177 citations

10.1186/s13550-023-00990-7

Inter- and intraobserver agreement of the quantitative assessment of [<sup>99m</sup>Tc]-labelled anti-programmed death-ligand 1 (PD-L1) SPECT/CT in non-small cell lung cancer.

Hughes DJ, Chand G, Goh V, Cook GJR.

2020-12-016 citations

10.1186/s13550-020-00734-x

Interventions

DIAGNOSTIC_TEST[99mTc]-NM-01 SPECT/CT

Technetium labelled anti-PD-L1 single-domain antibody (NM-01) single-photon emission computed tomography (SPECT)/CT

Study design

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

No

Inclusion criteria

* Aged 18 or above * Patients with histologically confirmed NSCLC or melanoma scheduled for PD1/PDL1 immunotherapy alone or in combination with other systemic anti-cancer therapy. * Willingness and ability to comply with scheduled study visits and tests.

Exclusion criteria

* Pregnant or lactating women * Concomitant uncontrolled medical conditions * Patients likely to require palliative radiotherapy within the first 12 weeks of treatment or radiotherapy to target lesion(s) received within preceding 42 days * More than 3 months between IHC PDL1 and study recruitment * Patients who have received other systemic anti-cancer therapy within preceding 14 days * Prognosis less than 3 months * Previous anticancer treatment with any checkpoint inhibitor or other immunotherapy, i.e. only immunotherapy naïve patients

Design outcomes

Primary

Measure	Time frame	Description
Percentage change in PD-L1 expression (using [99mTc] SPECT) in NSCLC.	Up to 18 weeks	PD-L1 expression reported by measurement of tumour:blood pool ratio and/or SUV of \[99mTc\]-anti-PD-L1-sdAb uptake on SPECT. Measurement at baseline and 9 weeks will be compared to determine % change. Standard clinical imaging assessment at 9 and 18 weeks used as comparators.
Percentage change in PD-L1 expression (using [99mTc] SPECT) in melanoma lesions.	Up to 24 weeks	PD-L1 expression reported by measurement of tumour:blood pool ratio and/or SUV of \[99mTc\]-anti-PD-L1-sdAb uptake on SPECT. Measurement at baseline and 12 weeks will be compared to determine % change. Standard clinical imaging assessment at 12 and 24 weeks used as comparators.

Secondary

Measure	Time frame	Description
Report PD-L1 tumour expression (using [99mTc] SPECT) of immunotherapy naive participants compared to PD-L1 expression determine by standard immunohistochemistry.	Baseline	Correlation between PD-L1 expression reported by measurement of tumour:blood pool ratio and/or SUV of \[99mTc\]-anti-PD-L1-sdAb uptake on SPECT and PD-L1 expression determined by standard of care immunohistochemistry.

Countries

United Kingdom

Contacts

Primary ContactDaniel J Hughes, MBBS MRCP

daniel.hughes@kcl.ac.uk020 7188 7188

Outcome results

None listed