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 type

• Study type:
  Non-interventional study
• Scope of the study:
  Disease epidemiology

Non-interventional study

• Non-interventional study design:
  Other
• Non-interventional study design, other:
  Retrospective Observational Study with no medicinal product involvement

Study drug and medical condition

• Medical condition to be studied:
  Non-small cell lung cancer metastatic

Population studied

• Age groups:
  Adults (18 to < 46 years)

  Adults (46 to < 65 years)

  Adults (65 to < 75 years)

  Adults (75 to < 85 years)

  Adults (85 years and over)
• Estimated number of subjects:
  500

Study design details

• Main study objective:
  To analyse the correlation of PD-L1 expression in the primary site (lung) and associated hilar/mediastinal LNs (N1 and N2) in NSCLC looking at all variables in both primary tumour and hilar/ mediastinal LN.
• Outcomes:
  To analyse the correlation of PD-L1 expression in the primary site (lung) and associated hilar/mediastinal LNs (N1 and N2) in NSCLC looking at all variables in both primary tumour and hilar/ mediastinal LN. Correlate the PD-L1 expression with:HistologyTumour sizetumour locationPredominant adenocarcinoma subtypeLymphovascular invasionClinical characteristicsagesexsmoking historyPET SUV data if available
• Data analysis plan:
  Samples (primary tumour and hilar/mediastinal LNs) from 500 patients who underwent lung resection and hilar and/or mediastinal lymphadenectomy for NSCLC (squamous and non-squamous cell cancer) without primary systemic treatment or Radiotherapy will be collected and analysed for PD-L1 expression.Expression of PD-L1 will be analysed on tumour samples in both primary tumours and hilar/ mediastinal LNs using the 22C3 pharmdx DAKO assay (5). The selected blocks will be retrieved and processed using DAKO PD-L1 immunohistochemistry 22C3 pharmDx Kit. PD-L1 stained slides will be reviewed by two pathologists independently, using the recommended scoring system. For cases where there is discrepancy, the two histopathologists will review the stains jointly and the consensus score will be used for data analysis.The tumour proportion score (TPS) will be documented for each sample according to the following categories:PD-L1 negative: <1%≥ 1-49%≥ 50%