Non-small cell lung cancer
Conditions
Interventions
VENTANA PD-L1 (SP263) CDx Assay
Sponsors
Gilead Sciences, Inc.
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: It must be an FFPE tumor specimen submitted for Gilead Study STAR-121 processed in accordance with standard practice; It must contain sufficient tumor tissue for interpretation at the discretion of the reviewing pathologist; and If an FFPE tissue block is unavailable, unstained FFPE slides can be submitted.
Exclusion criteria
Exclusion criteria: It is a fine needle aspirate or cytology specimen; 2. It consists of tissue that has been decalcified*;** 3. It is known to be fixed in 95% alcohol, AFA, or PREFER™; and 4. Cut slides were prepared over 12 months prior to staining. * Prior to testing any specimen that cones bone tissue, 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 has been decalcified or not, the sample must be held and the submitting site queried as to whether the sample has been decalcified. If the sample has been decalcified, testing cannot proceed. ** The protocol for Study STAR-121 does not allow bone specimens to be submitted for testing.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoints for the Dx study are the dual primary efficacy endpoints defined in Study STAR-121: - OS of Group A (DOM+ZIM in combination with chemotherapy) relative to Group B (PEMBRO in combination with chemotherapy), with OS defined as the time from the date of randomization to the date of death from any cause (both in participants with positive PD-L1 expression [= 1% TC] and in all randomized participants as dual primary endpoints)Performance of VENTANA PD-L1 (SP263) CDx Assay will be considered acceptable if the results of Study STAR-121 support the efficacy of zimberelimab and domvanalimab in combination with chemotherapy relative to prembrolizumab in combination with chemotherapy in the PD-L1 positive (=1% TC) patient population identified by the investigational assay. | — |
Secondary
| Measure | Time frame |
|---|---|
| Not appicable | — |
Countries
Argentina, Austria, Belgium, Brazil, Canada, Chile, China, France, Germany, Israel, Italy, Japan, Luxembourg, Mexico, Netherlands, Portugal, Singapore, South Korea, Spain, Taiwan, Turkey, United Kingdom, United States
Outcome results
None listed