Non-small Cell Lung CancerPECanNCT04436406
PD-L1 Expression in Cancer (PECan Study).
A study testing [99mTc]-NM-01 SPECT/CT in people with Non-small Cell Lung Cancer and Melanoma, run by Guy's and St Thomas' NHS Foundation Trust at 1 site in United Kingdom.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-small Cell Lung Cancer, Melanoma
- What is being tested?
- [99mTc]-NM-01 SPECT/CT
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 11 Mar 2020to 31 Jan 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Guy's and St Thomas' NHS Foundation Trust
London
Daniel J Hughes, MBBS MRCP, (0044)20 7188 7188 ext. 88378, daniel.hughes@kcl.ac.uk
Gary JR Cook, (0044)20 7188 7188 ext. 88378, gary.cook@kcl.ac.uk
About this study
Official title: Measurement of PD-L1 Expression in Cancer to Monitor Treatment Response.
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.
Read the 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.
- Conditions
- Non-small Cell Lung Cancer, Melanoma
- Being tested
- [99mTc]-NM-01 SPECT/CT
- Keywords
- immunotherapy, checkpoint inhibitors, molecular imaging, non-small cell lung cancer, melanoma
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[99mTc]-NM-01 SPECT/CTDiagnostic test
Technetium labelled anti-PD-L1 single-domain antibody (NM-01) single-photon emission computed tomography (SPECT)/CT
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: [99mTc]-NM-01 SPECT/CT |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
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.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2020
- Study start11 Mar 2020
- Primary completion31 Oct 2023 (estimated)
- Study completion31 Jan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Non-small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Guy's and St Thomas' NHS Foundation TrustThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guy's and St Thomas' NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- NanoMab Technology (UK) Limited
- Responsible party
- Sponsor
- Investigators
- Gary JR Cook, Principal investigator, King's College London, London, UK
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04436406
- Sponsor's protocol ID
- IRAS 256684
- Acronym
- PECan
- Status last verified
- Dec 2022
- First submitted
- 9 Mar 2020
- Last updated
- 15 Dec 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 40188291Hughes 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.
PubMed 37256434Nazir 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.
PubMed 37195370
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measurement of PD-L1 Expression in Cancer to Monitor Treatment Response.
- ClinicalTrials.gov ID
- NCT04436406
- Acronym / sponsor ID
- PECan / IRAS 256684
- Conditions
- Non-small Cell Lung Cancer, Melanoma
- Keywords
- immunotherapy, checkpoint inhibitors, molecular imaging, non-small cell lung cancer, melanoma
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Guy's and St Thomas' NHS Foundation TrustUniversity, hospital or other
- Collaborators
- NanoMab Technology (UK) Limited
- Study start
- 11 Mar 2020 (actual)
- Primary completion
- 31 Oct 2023 (estimated)
- Study completion
- 31 Jan 2024 (estimated)
- First posted
- 18 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Advanced malignant disease (non-small cell lung cancer or malignant melanoma) | Experimental | Diagnostic Test: [99mTc]-NM-01 SPECT/CTGroup 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| [99mTc]-NM-01 SPECT/CTTechnetium labelled anti-PD-L1 single-domain antibody (NM-01) single-photon emission computed tomography (SPECT)/CT | Diagnostic test | Advanced malignant disease (non-small cell lung cancer or malignant melanoma) |
Primary outcome
Percentage change in PD-L1 expression (using [99mTc] SPECT) in NSCLC.
Time frame: 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.
Time frame: 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.
1 secondary outcome
Report PD-L1 tumour expression (using [99mTc] SPECT) of immunotherapy naive participants compared to PD-L1 expression determine by standard immunohistochemistry.
Time frame: Baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2022.
- Derived from this study: PubMed 40188291Hughes 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.
- Derived from this study: PubMed 37256434Hughes 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.
- Derived from this study: PubMed 37195370Nazir 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gary JR Cook principal investigator
King's College London, London, UK
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing [99mTc]-NM-01 SPECT/CT in people with Non-small Cell Lung Cancer and Melanoma, run by Guy's and St Thomas' NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Daniel J Hughes, MBBS MRCP (020 7188 7188 ext. 88378, daniel.hughes@kcl.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage change in PD-L1 expression (using [99mTc] SPECT) in NSCLC. (time frame: Up to 18 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04436406, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Dec 2022.