locally advanced Lung Cancer unresectable or metastatic NSCLC
Conditions
Interventions
 
Lung biopsies will be obtained in the framework of the pharmaceutical study. 
Sponsors
Ventana Medical Systems, Inc. (Roche Tissue Diagnostics)
Eligibility
Age
16 Years to 99 Years
Inclusion criteria
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 [redacted] 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: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoints of the clinical performance study are the primary efficacy endpoints described in [redacted] Study protocol, as listed below: • Progression-free survival (PFS) per RECIST 1.1 by blinded independent central review (BICR) in participants with PD-L1 expression in [redacted] • Overall survival (OS) in participants with PD-L1 expression in [redacted] | — |
Secondary
| Measure | Time frame |
|---|---|
| Not applicable. | — |
Countries
Argentina, Belgium, Brazil, Bulgaria, Canada, China, Croatia, Czech Republic, Estonia, Finland, France, Germany, Greece, Hungary, India, Italy, Japan, Mexico, Netherlands, Norway, Panama, Philippines, Poland, Portugal, Romania, Serbia, Singapore, Slovakia, Slovenia, South Korea, Spain, Sweden, Taiwan, Thailand, Turkey, United States
Contacts
Public ContactHD Damasco
Ventana Medical Systems, Inc. (Roche Tissue Diagnostics or “RTD”)
Outcome results
None listed