Clinical trial · Interventional
PD-L1 Expression in Cancer (PECan Study).
Measurement of PD-L1 Expression in Cancer to Monitor Treatment Response.
NCT04436406CI-TRIAL-00062717PECanunknownN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Melanoma | Melanoma | ONTOLOGY_EXACT | 0.98 |
| Non-small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| [99mTc]-NM-01 SPECT/CT | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Advanced malignant disease (non-small cell lung cancer or malignant melanoma)
- description
- 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.
- interventionNames
- Diagnostic Test: [99mTc]-NM-01 SPECT/CT
Primary outcomes (2)
- measure
- Percentage change in PD-L1 expression (using [99mTc] SPECT) in NSCLC.
- timeFrame
- Up to 18 weeks
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (3)
- DERIVEDHughes 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
- DERIVEDHughes 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
- DERIVEDNazir 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