Study to Assess How Well a Laboratory Test Measures Levels of a Specific Marker in Lung Cancer Samples from a Clinical Trial

Clinical Performance Study Protocol for Use of the VENTANA PD-L1 (SP263) CDx Assay: Evaluation of PD-L1 Expression Levels in Non-small Cell Lung Cancer Specimens from Phase III Study CA2241093 (Relativity 1093) - Study to Assess How Well a Laboratory Test Measures Levels of a Specific Marker in Lung Cancer Samples from a Clinical Trial

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON57685

Enrollment

Registered

2025-03-10

Start date

2026-01-08

Completion date

Unknown

Last updated

2026-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lung Cancer

Interventions

VENTANA PD-L1 (SP263) CDx Assay&nbsp

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: The inclusion criteria for testing with the IVD is:1. It must be a formalin-fixed, paraffin-embedded (FFPE) tumor specimen submitted forCA2241093 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

Exclusion criteria: The exclusion criteria for testing with the IVD is:1. It is fixed in alcohol-formalin-acetic acid (AFA), 95% alcohol, or any other alcohol basedfixative, or PREFER; or2. It is a fine needle aspirate or a cytology specimen; or3. It consists of tissue containing bone that has been decalcified;*4. Cut slides prepared from FFPE blocks beyond the cut-slide stability of 12 months prior to staining.

Design outcomes

Primary

Measure	Time frame
Primary study outcome of the IVD clinical performance studyOverall survival (OS), defined as the time between the date of randomization and the date of death due to any cause, among randomized participants with PD-L1 expression 1-49% TC (Primary efficacy endpoint). OS, defined as the time between the date of randomization and the date of death due to any cause, among randomized participants with PD-L1 expression = 1% TC (Key secondary efficacy endpoint).	—

Measure

Time frame

Primary study outcome of the IVD clinical performance studyOverall survival (OS), defined as the time between the date of randomization and the date of death due to any cause, among randomized participants with PD-L1 expression 1-49% TC (Primary efficacy endpoint). OS, defined as the time between the date of randomization and the date of death due to any cause, among randomized participants with PD-L1 expression = 1% TC (Key secondary efficacy endpoint). 

—

Secondary

Measure	Time frame
Secondary study outcome of the IVD clinical performance studyStaining performance of the VENTANA PD-L1 (SP263) CDx Assay will be also evaluated in terms of: Initial and final staining acceptability rate Initial and final background staining acceptability rates Initial and final tissue morphology acceptability rates	—

Countries

Argentina, Australia, Austria, Belgium, Brazil, Chile, Colombia, Denmark, France, Germany, India, Ireland, Italy, Japan, Mexico, Netherlands, New Zealand, Poland, Portugal, Romania, Saudi Arabia, South Africa, South Korea, Spain, Switzerland, Taiwan, Turkey, United Kingdom

Contacts

Public ContactJL Lappin

ARC Regulatory Ltd

regs@arc-regulatory.co.uk+44 028 7963 9304

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP) · Data processed: Feb 3, 2026