Clinical Performance Study Protocol for Use of VENTANA PD-L1 (SP263) CDx Assay in AstraZeneca Study D798AC00001(eVOLVE-Lung02): A Phase III, Two-Arm, Parallel, Randomized, Multi-Center, Open-Label, Global Study to Determine the Efficacy of Volrustomig (MEDI5752) Plus Chemotherapy Versus Pembrolizumab Plus Chemotherapy for First-Line Treatment of Patients with Metastatic Non-Small Cell Lung Cancer (mNSCLC) (eVOLVE-Lung02)

Phase 3

Conditions: Metastatic Non-Small Cell Lung Cancer with PD-L1<50%
Non-Small Cell Lung Cancer
10027476

Registration Number: NL-OMON56319

Lead Sponsor: Astra Zeneca

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: 32

Inclusion Criteria

1. It must be an FFPE tumor specimen submitted for AstraZeneca Study
eVOLVE-Lung02 under appropriate patient informed consent and processed in
accordance with standard practice;
2. It must contain sufficient 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 staining with the investigational essay if any
of the following conditions apply:

1. It was known to be fixed in alcohol-formalin-acetic acid (AFA), 95% alcohol
or any other alcohol-based fixative, or;
2. It consists of tissue that has been decalcified;
3. It is a fine needle aspirate or cytology specimen; or
4. Cut slides were prepared over 12 months prior to staining

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>- Progression free survival (PFS) in the PD-L1 TC <1% population. PFS is<br /><br>defined as the time from randomization until radiological progression per<br /><br>RECIST 1.1 as assessed by blinded independent central review (BICR), or death<br /><br>due to any cause (in the absence of progression)<br /><br>- Overall survival (OS) in the PD-L1 TC <1% population. OS is defined as the<br /><br>time from randomization until the date of death due to any cause</p><br>

Secondary Outcome Measures