NCT03258788

A Translational Study Investigating PD-L1 Expression After Radiotherapy for Non-small Cell Lung Cancer

A Translational Study Investigating PD-L1 Expression After Radiotherapy for Non-small Cell Lung Cancer (NSCLC)

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 15 (actual)
• Sponsor: The Christie NHS Foundation Trust · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 palliative). Archival tumour biopsies will be analysed for baseline Programmed Death Ligand 1 (PD-L1) expression. Some participants will have a biopsy before radiotherapy if the archive biopsy is not suitable. Participants will be required to undergo an additional mandatory biopsy of the irradiated site during the second week of radiotherapy.

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 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: Stage 1: 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). Stage 2: A further 15 evaluable participants will be recruited onto the study to achieve a total of 30 evaluable participants.

Conditions

• Non-Small Cell Lung Cancer

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2019-01-03
• Primary completion: 2020-03-18
• Completion: 2020-03-18
• First posted: 2017-08-23
• Last updated: 2023-04-03

Locations

3 sites across 1 country: United Kingdom