A Translational Study Investigating PD-L1 Expression After Radiotherapy for Non-small Cell Lung Cancer (PD-RAD)
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|ClinicalTrials.gov Identifier: NCT03258788|
Recruitment Status : Completed
First Posted : August 23, 2017
Last Update Posted : July 15, 2020
|Condition or disease||Intervention/treatment|
|Non-Small Cell Lung Cancer||Procedure: Biopsy and blood samples|
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 with palliative or radical radiotherapy. This is a non-CTIMP study.
All participants will have a minimum of 1 mandatory biopsy (during radiotherapy [irradiated site]) and the potential to have a pre-treatment biopsy if archival biopsy does not meet the suitability criteria.
Participants will have up to a maximum of 2 additional optional biopsies (during radiotherapy [within the RT field e.g supraclavicular fossa node], [outside RT field e.g. skin met]).
Blood samples will also be taken on study at specified time points for immune monitoring (exploratory endpoints).
The study will be carried out in two stages as follows:
Following the enrolment of the first 15 evaluable participants, an interim analysis will take place by the Trial Steering Committee (TSC). The TSC will make a recommendation on whether recruitment should continue to the Trial Management Group (TMG).
A further 15 evaluable participants will be recruited onto the study to achieve a total of 30 evaluable participants.
|Study Type :||Observational|
|Actual Enrollment :||6 participants|
|Official Title:||A Translational Study Investigating PD-L1 Expression After Radiotherapy for Non-small Cell Lung Cancer (NSCLC)|
|Actual Study Start Date :||January 3, 2019|
|Actual Primary Completion Date :||March 18, 2020|
|Actual Study Completion Date :||March 18, 2020|
Non-Small Cell Lung Cancer
Participants with NSCLC not suitable for concurrent CTRT, being treated with standard radiotherapy (radical or palliative). All participants will be required to undergo a post radiotherapy course biopsy and will have blood samples taken.
Procedure: Biopsy and blood samples
Archival tumour biopsies will be analysed for baseline PD-L1 expression. Some participants will have a biopsy before radiotherapy if the archival biopsy is not suitable.
Participants will be required to undergo an additional mandatory biopsy of the irradiated site during the second week. Patients must have completed at least 1 week of the planned treatment before taking the biopsy.
Participants will also be asked for consent to donate 50ml blood pre biopsy (at baseline and week 2) and at the end of radiotherapy; as well as 10ml blood before #2 radiotherapy and weekly throughout treatment.
- Achieving paired biopsies for PD-L1 assessment in 21 of the 30 evaluable participants [ Time Frame: Up to 6.5 weeks from start of radiotherapy ]
- Suitability of pre and during radiotherapy biopsy for PD-L1 testing [ Time Frame: Up to 6.5 weeks from start of radiotherapy ]
- Change in PD-L1 expression level during treatment [ Time Frame: Up to 6.5 weeks from start of radiotherapy ]
- Difference in PD-L1 expression level in 'out of radiotherapy field' sites compared with irradiated sites [ Time Frame: Up to 6.5 weeks from start of radiotherapy ]
- Immune monitoring of primary tumour and peripheral blood mononuclear cells [ Time Frame: Up to 6.5 weeks from start of radiotherapy ]
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03258788
|St. James's Univerisity Hospital|
|Leeds, United Kingdom, LS9 7TF|
|University College Hospital|
|London, United Kingdom, NW1 2BU|
|The Christie NHS Foundation Trust|
|Manchester, United Kingdom, M20 4BX|
|Study Chair:||Timothy Illidge||The Christie NHS Foundation Trust|