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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

Tracking Information
First Submitted Date August 10, 2017
First Posted Date August 23, 2017
Last Update Posted Date July 15, 2020
Actual Study Start Date January 3, 2019
Actual Primary Completion Date March 18, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 20, 2018)
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 ]
Original Primary Outcome Measures
 (submitted: August 22, 2017)
Achieving paired biopsies for PD-L1 assessment in 21 of the 30 evaluable participants [ Time Frame: Up to 7.5 weeks from start of radiotherapy ]
Change History
Current Secondary Outcome Measures
 (submitted: June 20, 2018)
Suitability of pre and during radiotherapy biopsy for PD-L1 testing [ Time Frame: Up to 6.5 weeks from start of radiotherapy ]
Original Secondary Outcome Measures
 (submitted: August 22, 2017)
  • Suitability of pre and post radiotherapy biopsy for PD-L1 testing [ Time Frame: Up to 7.5 weeks from start of radiotherapy ]
  • Change in PD-L1 expression level between paired biopsies [ Time Frame: Up to 7.5 weeks from start of radiotherapy ]
Current Other Pre-specified Outcome Measures
 (submitted: June 20, 2018)
  • 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 ]
Original Other Pre-specified Outcome Measures
 (submitted: August 22, 2017)
  • Change in PD-L1 expression level during treatment [ Time Frame: Up to 7.5 weeks from start of radiotherapy ]
  • Change in PD-L1 expression level in 'out of radiotherapy field' sites [ Time Frame: Up to 7.5 weeks from start of radiotherapy ]
  • Immune monitoring of primary tumour and peripheral blood mononuclear cells [ Time Frame: Up to 7.5 weeks from start of radiotherapy ]
 
Descriptive Information
Brief Title A Translational Study Investigating PD-L1 Expression After Radiotherapy for Non-small Cell Lung Cancer
Official Title A Translational Study Investigating PD-L1 Expression After Radiotherapy for Non-small Cell Lung Cancer (NSCLC)
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.
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.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
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.
Sampling Method Non-Probability Sample
Study Population Hospital clinic
Condition Non-Small Cell Lung Cancer
Intervention 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.

Study Groups/Cohorts 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.
Intervention: Procedure: Biopsy and blood samples
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: July 14, 2020)
6
Original Estimated Enrollment
 (submitted: August 22, 2017)
30
Actual Study Completion Date March 18, 2020
Actual Primary Completion Date March 18, 2020   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number NCT03258788
Other Study ID Numbers CFTSp095, 14_DOG07_183
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party Emmie Taylor, The Christie NHS Foundation Trust
Study Sponsor The Christie NHS Foundation Trust
Collaborators AstraZeneca
Investigators
Study Chair: Timothy Illidge The Christie NHS Foundation Trust
PRS Account The Christie NHS Foundation Trust
Verification Date July 2020