A Translational Study Investigating PD-L1 Expression After Radiotherapy for Non-small Cell Lung Cancer (NSCLC)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 3
- 主要终点
- Achieving paired biopsies for PD-L1 assessment in 21 of the 30 evaluable participants
研究概览
简要总结
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.
详细描述
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:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Achieving paired biopsies for PD-L1 assessment in 21 of the 30 evaluable participants
时间窗: Up to 6.5 weeks from start of radiotherapy
次要结局
- Suitability of pre and during radiotherapy biopsy for PD-L1 testing(Up to 6.5 weeks from start of radiotherapy)