Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
NA
30 participants
INTERVENTIONAL
2020-03-11
2024-01-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Advanced malignant disease (non-small cell lung cancer or malignant melanoma)
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.
[99mTc]-NM-01 SPECT/CT
Technetium labelled anti-PD-L1 single-domain antibody (NM-01) single-photon emission computed tomography (SPECT)/CT
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
[99mTc]-NM-01 SPECT/CT
Technetium labelled anti-PD-L1 single-domain antibody (NM-01) single-photon emission computed tomography (SPECT)/CT
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
NanoMab Technology (UK) Limited
INDUSTRY
Guy's and St Thomas' NHS Foundation Trust
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Gary JR Cook
Role: PRINCIPAL_INVESTIGATOR
King's College London, London, UK
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Guy's and St Thomas' NHS Foundation Trust
London, , United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Daniel J Hughes, MBBS MRCP
Role: primary
Gary JR Cook
Role: backup
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
IRAS 256684
Identifier Type: -
Identifier Source: org_study_id