A Retrospective Evaluation of PD-L1 expression on primary non-small cell lung cancer samples and associated involved hilar or mediastinal lymph nodes (N1 or N2) (REPLICA)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/26468
• EU PAS number:
  EUPAS26467
• Study ID:
  26468
• Official title and acronym:
  A Retrospective Evaluation of PD-L1 expression on primary non-small cell lung cancer samples and associated involved hilar or mediastinal lymph nodes (N1 or N2) (REPLICA)
• DARWIN EU® study:
  No
• Study countries:
  United Kingdom
• Study description:
  The aim of this study is to evaluate whether there is heterogeneity of PD-L1 expression, between the primary NSCLC tumours and the associated hilar/ mediastinal lymph nodes (LNs) from the same patient at the time of lung resection.Samples (primary tumour and hilar/mediastinal LNs, N1 or N2) from 500 consecutive chemotherapy naïve patients who have undergone lung resection and hilar/ mediastinal lymphadenectomy for NSCLC (squamous and non-squamous cell cancer) without primary systemic treatment or Radiotherapy have been collected and will be analysed for PD-L1 expression. All tissue samples will be anonymized.
• Study status:
  Planned

Research institution and networks

Institutions

Guy's and St Thomas' NHS Foundation Trust

Birmingham University Hospital Birmingham, UK

Study timelines

Date when funding contract was signed

Planned: 04/09/2018

Study start date

Planned: 30/10/2018

Date of final study report

Planned: 31/07/2019

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

MSD

Study protocol

Initial protocol

REPLICA protocol v1.0 19Jan2018

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable