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Clinical Trials/NL-OMON56319
NL-OMON56319
Not yet recruiting
Phase 3

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) - eVOLVE-Lung02

Astra Zeneca0 sites32 target enrollmentTBD
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ConditionsMetastatic Non-Small Cell Lung Cancer with PD-L1<50%Non-Small Cell Lung Cancer10027476

Overview

Phase
Phase 3
Intervention
Not specified
Conditions
Metastatic Non-Small Cell Lung Cancer with PD-L1<50%
Sponsor
Astra Zeneca
Enrollment
32
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
Astra Zeneca

Eligibility Criteria

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

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

Outcomes

Primary Outcomes

Not specified

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