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NCT Number: NCT03258788

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

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.

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Key information

Conditions

Non-small Cell Lung Cancer Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

St. James's Univerisity Hospital, Leeds, United Kingdom

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

  • 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

Treatment and study plan

Biopsy and blood samples

Procedure

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.

Primary outcomes

  1. 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

Secondary outcomes

  1. Suitability of pre and during radiotherapy biopsy for PD-L1 testing

    Time frame: Up to 6.5 weeks from start of radiotherapy

Other outcomes

  1. Change in PD-L1 expression level during treatment

    Time frame: Up to 6.5 weeks from start of radiotherapy

  2. 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

  3. Immune monitoring of primary tumour and peripheral blood mononuclear cells

    Time frame: Up to 6.5 weeks from start of radiotherapy

Sponsors and collaborators

Lead sponsor

The Christie NHS Foundation Trust

Other

Collaborators

  • AstraZeneca

Registry information

Official study title

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

Acronym: PD-RAD

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Aug 23, 2017
Registry last updated
Apr 3, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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