PD-L1 Expression in Cancer (PECan Study).

Non-small Cell Lung Cancer Clinical Trial

— PECan  

Official title:

Measurement of PD-L1 Expression in Cancer to Monitor Treatment Response.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04436406
• Other study ID #: IRAS 256684
• Status: Recruiting
• Phase: N/A
• Start date: March 11, 2020
• Est. completion date: January 31, 2024

Study information

• Verified date: December 2022
• Source: Guy's and St Thomas' NHS Foundation Trust
• Contact: Daniel J Hughes, MBBS MRCP
• Phone: 020 7188 7188
• Email: daniel.hughes[@]kcl.ac.uk
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 cancer in immunotherapy naïve patients using [99mTc]-anti-PD-L1 SPECT/CT and immunohistochemistry.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: January 31, 2024
• Est. primary completion date: October 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Melanoma
• Non-small Cell Lung Cancer

Intervention

Diagnostic Test:
• [99mTc]-NM-01 SPECT/CT
Technetium labelled anti-PD-L1 single-domain antibody (NM-01) single-photon emission computed tomography (SPECT)/CT

Locations

Country	Name	City	State
United Kingdom	Guy's and St Thomas' NHS Foundation Trust	London

Sponsors (2)

Lead Sponsor	Collaborator
Guy's and St Thomas' NHS Foundation Trust	NanoMab Technology (UK) Limited

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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.	Baseline