Status:
COMPLETED
A Translational Study Investigating PD-L1 Expression After Radiotherapy for Non-small Cell Lung Cancer
Lead Sponsor:
The Christie NHS Foundation Trust
Collaborating Sponsors:
AstraZeneca
Conditions:
Non-Small Cell Lung Cancer
Eligibility:
All Genders
18+ years
Brief Summary
Participants with Non-Small Cell Lung Cancer (NSCLC), Performance Status (PS) 0-2, not suitable for concurrent Chemo-Radiotherapy (CTRT), will be treated with standard radiotherapy (radical or palliat...
Detailed Description
The purpose of this prospective, multicentre, non-randomised translational study is to provide proof of feasibility of achieving paired biopsies for PD-L1 assessment in patients with NSCLC treated wit...
Eligibility Criteria
Inclusion
- Histologically confirmed NSCLC
- Diagnostic/pre-treatment biopsy suitable for PD-L1 analysis\*
- Tumour judged inoperable by a lung MDT
- Tumour that is accessible to core biopsy
- Age 18 and over, no upper age limit
- Performance status (PS) - ECOG 0-2
- Participant considered suitable for radiotherapy (palliative or radical) or sequential chemo-radiotherapy
- Before participant registration, written informed consent must be given according to GCP and national regulations
- Pre-treatment biopsy must be from gross tumour volume within planned radiation field, and must also:
- have been formalin fixed for \>12h and ≤24h
- have tumour tissue and morphology confirmed by H\&E staining
- contain sufficient tumour cells (\>100) to determine PD-L1 status
Exclusion
- Participant suitable for standard concurrent CTRT
- Participant deemed unsuitable for repeat biopsies in the opinion of the treating oncologist
- Participant known to have an EGFR mutation or an ALK rearrangement
- Intercurrent or history of hepatitis B, C or human immunodeficiency virus infection, if known
- Participants who have received more than 1 line of chemotherapy prior to radiotherapy
Key Trial Info
Start Date :
January 3 2019
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
March 18 2020
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT03258788
Start Date
January 3 2019
End Date
March 18 2020
Last Update
April 3 2023
Active Locations (3)
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1
St. James's Univerisity Hospital
Leeds, United Kingdom, LS9 7TF
2
University College Hospital
London, United Kingdom, NW1 2BU
3
The Christie NHS Foundation Trust
Manchester, United Kingdom, M20 4BX