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

Conditions: Lung Cancer
10024967
on-Small-Cell-Lung Cancer (NSCLC)
locally advanced
unresectable or metastatic NSCLC

Registration Number: NL-OMON56986

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

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: 10

Inclusion Criteria

To be included in this Dx protocol, a specimen must meet all of the following
criteria:
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
practice;
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
submitted.

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
specimen;
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
or does not specify
whether the sample was decalcified or not, the sample must be held and the
submitting site
queried. If the sample has been decalcified, testing cannot proceed.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary endpoints of the clinical performance study are the primary<br /><br>efficacy endpoints described in §9.3.2 of the GALAXIES LUNG-301 Study<br /><br>protocol, as listed below:<br /><br>• Progression-free survival (PFS) per RECIST 1.1 by blinded<br /><br>independent central review (BICR) in participants with PD-L1<br /><br>expression in >= 50% TC<br /><br>• Overall survival (OS) in participants with PD-L1 expression in >= 50%<br /><br>TC </p><br>

Secondary Outcome Measures