PD-L1 Expression in Lung Cancer (PELICAN) [Version 1.0]
Research type
Research Study
Full title
A single-arm, Phase II study to evaluate PD-L1 Expression in Non-Small Cell Lung Cancer using the 99mTc Labelled Anti-PD-L1 single domain antibody (NM-01)
IRAS ID
290974
Contact name
Gary Cook
Contact email
Sponsor organisation
NanoMab Technology (UK) Ltd.
Eudract number
2020-002809-26
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
MHRA CTA Approval Number, CTA 53479/0001/001-0001
Duration of Study in the UK
1 years, 3 months, 0 days
Research summary
Novel immunotherapeutic drugs, notably checkpoint inhibitors, have revolutionised the approach to anti-cancer therapies with significant and long-lasting responses demonstrated in cancers that respond poorly to other standard therapies, such as chemotherapy. However, only a proportion of patients respond favourably and the treatments can cause significant side-effects. Therefore, predictors of response are important to help direct appropriate patient management.
PD-L1 expression measured by immunohistochemistry on tissue biopsy has been shown to be an important predictive and prognostic biomarker for anti-PD-1/PD-L1 checkpoint inhibitor therapy in several cancers, including in non-small cell lung cancer. However, expression of PD-L1 within and between tumours is widely variable and it is dynamic, changing over time and following certain treatments.
Molecular imaging of PD-L1 that can characterise a tumour and its metastases has the potential to provide a total tumoural expression that may better predict overall response to anti-PD-1/PD-L1 therapies without the need for repeated invasive biopsies.
We are now able to measure PD-L1 expression with a nuclear medicine imaging technique which is similar to a standard bone scan (99mTc-anti-PD-L1 single photon emission computed tomography - SPECT/CT, known as 99mTc-NM-01).
We propose measuring PDL1 expression with SPECT/CT imaging and compare how well the SPECT/CT imaging compares to PDL1 expression that is measured on biopsy specimens. We will also look for heterogeneity within the primary tumour and between the primary tumour and metastases, if any.
We will scan (99mTc-NM-01 SPECT/CT) 15 patients with lung cancer prior to any systemic anti-cancer therapy.
REC name
London - Westminster Research Ethics Committee
REC reference
21/LO/0122
Date of REC Opinion
8 Apr 2021
REC opinion
Further Information Favourable Opinion