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Clinical Trials/NL-OMON56986
NL-OMON56986
Not yet recruiting
Not Applicable

Clinical Performance Study Protocol for Use of VENTANA PD-L1(SP263) CDx Assay in GSK Study 213823 (GALAXIES LUNG-301) - GSK GALAXIES LUNG-301 PD-L1

Ventana Medical Systems, Inc. (Roche Tissue Diagnostics)0 sites10 target enrollmentTBD
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Conditionson-Small-Cell-Lung Cancer (NSCLC)locally advancedLung Cancerunresectable or metastatic NSCLC10024967

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
on-Small-Cell-Lung Cancer (NSCLC)
Sponsor
Ventana Medical Systems, Inc. (Roche Tissue Diagnostics)
Enrollment
10
Status
Not yet recruiting
Last Updated
last year
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
last year
Study Type
Interventional

Investigators

Sponsor
Ventana Medical Systems, Inc. (Roche Tissue Diagnostics)

Eligibility Criteria

Inclusion Criteria

  • •To be included in this Dx protocol, a specimen must meet all of the following
  • •1\. It must be a formalin\-fixed, paraffin embedded (FFPE) tumor
  • •specimen submitted for central PD\-L1 testing for the GALAXIES
  • •LUNG\-301 Study and processed in accordance with standard
  • •2\. It must contain sufficient tumor tissue for interpretation at the
  • •discretion of the reviewing pathologist; and
  • •3\. If an FFPE tissue block is unavailable, unstained FFPE slides can be

Exclusion Criteria

  • •A specimen will be excluded from the Dx protocol if any of the following
  • •criteria are true:
  • •1\. It is known to be fixed in 95% alcohol, alcohol\-formalin\-acetic acid
  • •(AFA), or PREFER;
  • •2\. It is a fine needle aspirate (FNA), cytology, bone marrow or bone
  • •3\. It consists of tissue containing bone that has been decalcified\*; or
  • •4\. Cut slides were prepared more than 12 months prior to staining.
  • •\*Prior to testing any specimen, evidence of decalcification must be
  • •obtained.This information may
  • •be obtained from the pathology report. If the pathology report is not available

Outcomes

Primary Outcomes

Not specified

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