Genmab GCT1046-06 NSCLC PD-L1 SP263

• Research type

  Research Study

• Full title

  Diagnostic Protocol for VENTANA PD-L1 (SP263) CDx Assay in Genmab study GCT1046-06

• IRAS ID

  349909

• Contact name

  Manish Subramaniam

• Contact email

  manishmani.subramaniam@q2labsolutions.com

• Sponsor organisation

  Roche Diagnostics Solutions

• Clinicaltrials.gov Identifier

  PS-24-08-048656 , Goosefish RD007098 Clinical Performance Study Eudamed Number

• Duration of Study in the UK

  2 years, 11 months, 1 days

• Research summary

  The investigational VENTANA PD-L1 (SP263) CDx Assay will be used to assess PD-L1 expression status by immunohistochemical (IHC) staining in formalin-fixed, paraffin- embedded (FFPE) NSCLC tissue specimens from patients screened for enrollment in the Study GCT1046-06. A PD-L1-positive (tumor cell [TC] ≥1%) expression status is required for study enrollment and PD-L1 expression at the TC 50% cutoff (TC 1 to 49% versus ≥50%) will be one of several stratification factors used in patient randomization.

• REC name

  North of Scotland Research Ethics Committee 1

• REC reference

  24/NS/0133

• Date of REC Opinion

  2 Dec 2024

• REC opinion

  Unfavourable Opinion