Oncology - Non-Small Cell Lung Cancer Lung Cancer Metastatic Non-Small Cell Lung Cancer
Conditions
Interventions
lung biopsies will be obtained as part of the pharmaceutical study (in case no
archived sample is available)
Sponsors
Ventana Medical Systems, Inc.(Roche Tissue Diagnostics (RTD))
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: To be eligible for staining with the VENTANA PD-L1 (SP263) CDx Assay in this diagnostic study, a specimen must meet all of the following criteria: 1. It must be a formalin-fixed, paraffin-embedded (FFPE) NSCLC tumor specimen submitted for Study GCT1046-06 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 staining with the VENTANA PD-L1 (SP263) CDx Assay in this diagnostic study based on any of the following: 1. It is known to be fixed in 95% alcohol or other alcohol-based fixative, alcohol-formalinacetic acid (AFA), or PREFER; 2. It is a fine needle aspirate (FNA) or cytology 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary Endpoint: The primary endpoint for the clinical performance study is the primary efficacy endpoint defined in the Study GCT1046-06 protocol: overall survival (OS). Primary Acceptance Criteria: The clinical performance of VENTANA PD-L1 (SP263) CDx Assay will be considered acceptable if the primary efficacy analysis of OS in the Study GCT1046-06 supports the efficacy of acasunlimab (GEN1046) in combination with pembrolizumab treatment in the population selected using the assay. | — |
Secondary
| Measure | Time frame |
|---|---|
| Additional Endpoints: Additional endpoints for this study include the following staining performance measures of the VENTANA PD-L1 (SP263) CDx Assay: - Initial and final staining acceptability rates for the assay - Initial and final tissue morphology acceptability rates for the assay - Initial and final background acceptability rates for the assay There are no pre-determined acceptance criteria associated with these additional endpoints. | — |
Countries
Netherlands
Outcome results
None listed