Clinical trial · Observational
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)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Non-Small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Biopsy and blood samples | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Non-Small Cell Lung Cancer
- description
- 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.
- interventionNames
- Procedure: Biopsy and blood samples
Primary outcomes (1)
- measure
- Achieving paired biopsies for PD-L1 assessment in 21 of the 30 evaluable participants
- timeFrame
- Up to 6.5 weeks from start of radiotherapy
Secondary outcomes (1)
- measure
- Suitability of pre and during radiotherapy biopsy for PD-L1 testing
- timeFrame
- Up to 6.5 weeks from start of radiotherapy
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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 radiotherapyReferences
Publications (1)
- DERIVEDCheng 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. PMID 41799515