PD-L1 Expression in Cancer (PECan Study).

NCT04436406 | Unknown DMC

• 1 other identifier: IRAS 256684
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Non-small Cell Lung Cancer; Melanoma

Keywords

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

Outcome Measures

Primary Outcomes (2)

• Percentage change in PD-L1 expression (using [99mTc] SPECT) in NSCLC.

  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.

  Up to 18 weeks

• Percentage change in PD-L1 expression (using [99mTc] SPECT) in melanoma lesions.

  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.

  Up to 24 weeks

Secondary Outcomes (1)

• Report PD-L1 tumour expression (using [99mTc] SPECT) of immunotherapy naive participants compared to PD-L1 expression determine by standard immunohistochemistry.

  Baseline

Study Arms (1)

Advanced malignant disease (non-small cell lung cancer or malignant melanoma)

EXPERIMENTAL

Group 1: Participants with non-small cell lung cancer (NSCLC) as per inclusion/exclusion criteria undergo baseline PD-L1 expression testing by immunohistochemistry and \[99m-Tc\]-anti-PD-L1 single-domain antibody SPECT/CT imaging at 0 and 9 weeks. FDG-PET/CT is also performed at baseline (0) and first follow-up (9) weeks scans, in addition to standard CT clinical imaging at 0, 9 and 18 weeks. Group 2: Participants with malignant melanoma (MM) as per inclusion/exclusion criteria undergo baseline PD-L1 expression testing by immunohistochemistry and \[99m-Tc\]-anti-PD-L1 single-domain antibody SPECT/CT imaging at 0 and 12 weeks. FDG-PET/CT is also performed as standard clinical imaging at baseline (0), first follow-up (12) weeks and 24 weeks.

Diagnostic Test: [99mTc]-NM-01 SPECT/CT

Interventions

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

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

Advanced malignant disease (non-small cell lung cancer or malignant melanoma)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Guy's and St Thomas' NHS Foundation Trust: lead
• NanoMab Technology (UK) Limited: collaborator

Study Sites (1)

Guy's and St Thomas' NHS Foundation Trust

London, United Kingdom

RECRUITING

Related Publications (3)

• 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. PD-L1 imaging with [99mTc]NM-01 SPECT/CT is associated with metabolic response to pembrolizumab with/without chemotherapy in advanced lung cancer. Br J Cancer. 2025 Jun;132(10):913-921. doi: 10.1038/s41416-025-02991-w. Epub 2025 Apr 5.

  PMID: 40188291 DERIVED

• Hughes DJ, Chand G, Johnson J, Bailey D, Adamson K, Goh V, Cook GJR. Inter-rater and intra-rater agreement of [99mTc]-labelled NM-01, a single-domain programmed death-ligand 1 (PD-L1) antibody, using quantitative SPECT/CT in non-small cell lung cancer. EJNMMI Res. 2023 May 31;13(1):51. doi: 10.1186/s13550-023-01002-4.

  PMID: 37256434 DERIVED

• Nazir MS, Hughes DJ, Chand G, Adamson K, Johnson J, Bailey D, Gibson V, Ting HH, Lyon AR, Cook GJR; PECan study group. [99mTc]-labelled anti-Programmed Death-Ligand 1 single-domain antibody SPECT/CT: a novel imaging biomarker for myocardial PD-L1 expression. EJNMMI Res. 2023 May 17;13(1):44. doi: 10.1186/s13550-023-00990-7.

  PMID: 37195370 DERIVED

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Melanoma

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Gary JR Cook

  King's College London, London, UK

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Daniel J Hughes, MBBS MRCP

CONTACT

020 7188 7188; daniel.hughes@kcl.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 9, 2020
• First Posted: June 18, 2020
• Study Start: March 11, 2020
• Primary Completion: October 31, 2023
• Study Completion: January 31, 2024
• Last Updated: December 15, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)