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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03258788
Recruitment Status : Completed
First Posted : August 23, 2017
Last Update Posted : July 15, 2020
Sponsor:
Collaborator:
AstraZeneca
Information provided by (Responsible Party):
Emmie Taylor, The Christie NHS Foundation Trust

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 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.

Condition or disease Intervention/treatment
Non-Small Cell Lung Cancer Procedure: Biopsy and blood samples

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.

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Study Type : Observational
Actual Enrollment : 6 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Biopsy

Group/Cohort Intervention/treatment
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.





Primary Outcome Measures :
  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 Outcome Measures :
  1. Suitability of pre and during radiotherapy biopsy for PD-L1 testing [ Time Frame: Up to 6.5 weeks from start of radiotherapy ]

Other Outcome Measures:
  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 ]

Biospecimen Retention:   Samples With DNA
Original diagnostic tumour blocks will be returned at the end of the study. New biopsy and blood samples taken may be used in future research.


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Hospital clinic
Criteria

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

Information from the National Library of Medicine

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


Locations
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United Kingdom
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
Sponsors and Collaborators
The Christie NHS Foundation Trust
AstraZeneca
Investigators
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Study Chair: Timothy Illidge The Christie NHS Foundation Trust
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Responsible Party: Emmie Taylor, Clinical Trials Project Manager, The Christie NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT03258788    
Other Study ID Numbers: CFTSp095, 14_DOG07_183
First Posted: August 23, 2017    Key Record Dates
Last Update Posted: July 15, 2020
Last Verified: July 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms