Non-Small Cell Lung CancerPD-RADNCT03258788
A Translational Study Investigating PD-L1 Expression After Radiotherapy for Non-small Cell Lung Cancer
An observational study of Non-Small Cell Lung Cancer, run by The Christie NHS Foundation Trust at 3 sites in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-Small Cell Lung Cancer
- What is being tested?
- Biopsy and blood samples
- Type of treatment
- Surgery or procedure
- How many people
- 15 participants
- Where
- 3 sitesUnited Kingdom
- Study dates
- 3 Jan 2019to 18 Mar 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Hospital clinic
Who may be able to join
- 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
Show all 12Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country.
United Kingdom3 sites
St. James's Univerisity Hospital
Leeds, LS9 7TF
University College Hospital
London, NW1 2BU
The Christie NHS Foundation Trust
Manchester, M20 4BX
About this study
Official title: A Translational Study Investigating PD-L1 Expression After Radiotherapy for Non-small Cell Lung Cancer (NSCLC)
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.
Read the 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
- Being tested
- Biopsy and blood samples
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biopsy and blood samplesProcedure or surgery
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Biopsy and blood samples |
What is being measured
The primary outcome is the main question the study is designed to answer.
Achieving paired biopsies for PD-L1 assessment in 21 of the 30 evaluable participants
Measured: Up to 6.5 weeks from start of radiotherapy
Secondary outcomes (1)
Suitability of pre and during radiotherapy biopsy for PD-L1 testing
Measured: Up to 6.5 weeks from start of radiotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2017
- Study start3 Jan 2019
- Primary completion18 Mar 2020
- Study completion18 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Non-Small Cell Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Christie NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- AstraZeneca
- Responsible party
- Sponsor
- Investigators
- Timothy Illidge, Study chair, The Christie NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03258788
- Sponsor's protocol ID
- CFTSp095, 14_DOG07_183
- Acronym
- PD-RAD
- Status last verified
- Mar 2023
- First submitted
- 10 Aug 2017
- Last updated
- 3 Apr 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Cheng S, Kordbacheh T, Banyard A, Chaturvedi A, Sanchez Martinez D, Hiley CT, Harris M, Chan C, Faivre-Finn C, Illidge TM, Cheadle EJ. Investigating the Immune Effects of Radiotherapy in Non-Small Cell Lung Cancer-Results of the PD-RAD Study. Oncol Res. 2026 Feb 24;34(3):14. doi: 10.32604/or.2025.072053. eCollection 2026.
PubMed 41799515
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Translational Study Investigating PD-L1 Expression After Radiotherapy for Non-small Cell Lung Cancer (NSCLC)
- ClinicalTrials.gov ID
- NCT03258788
- Acronym / sponsor ID
- PD-RAD / CFTSp095, 14_DOG07_183
- Conditions
- Non-Small Cell Lung Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- The Christie NHS Foundation TrustUniversity, hospital or other
- Collaborators
- AstraZeneca
- Study start
- 3 Jan 2019 (actual)
- Primary completion
- 18 Mar 2020 (actual)
- Study completion
- 18 Mar 2020 (actual)
- First posted
- 23 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Non-Small Cell Lung Cancer | – | Procedure: Biopsy and blood samplesParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Hospital clinic
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Biopsy and blood samplesArchival 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. | Procedure or surgery | Non-Small Cell Lung Cancer |
Primary outcome
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
1 secondary outcome
Suitability of pre and during radiotherapy biopsy for PD-L1 testing
Time frame: Up to 6.5 weeks from start of radiotherapy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2023.
- Derived from this study: PubMed 41799515Cheng S, Kordbacheh T, Banyard A, Chaturvedi A, Sanchez Martinez D, Hiley CT, Harris M, Chan C, Faivre-Finn C, Illidge TM, Cheadle EJ. Investigating the Immune Effects of Radiotherapy in Non-Small Cell Lung Cancer-Results of the PD-RAD Study. Oncol Res. 2026 Feb 24;34(3):14. doi: 10.32604/or.2025.072053. eCollection 2026.
- End of Trial Report - HRALink provided by the sponsor.
- University of Manchester - WebsiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Timothy Illidge study chair
The Christie NHS Foundation Trust
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Non-Small Cell Lung Cancer, run by The Christie NHS Foundation Trust at 3 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03258788, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2023; AzTrials last refreshed its copy on 5 Nov 2026.