Unresectable locally advanced or metastatic extrapulmonary neuroendocrine carcinomas (epNEC) Advanced or metastatic extra-pulmonary neuroendocrine cancer
Conditions
Interventions
VENTANA DLL3 (SP347) RxDx Assay
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 VENTANA DLL3 (SP347) RxDx Assay in this diagnostic study, a specimen must meet all of the following criteria: • It must consist of archival epNEC specimens submitted under informed consent for the purpose of enrollment testing in BI Study 1438-0011. • It must consist of an FFPE tissue block or of at least three unstained serial sections cut from an FFPE tissue block that allows for the assessment of DLL3 protein in FFPE epNEC specimens by light microscopy. • Case must be determined as ‘evaluable’ at pathologist's discretion, defined as tumor tissue with adequate numbers of tumor cells deemed suitable for evaluation, and is free of significant necrosis, crush artifact or other factors that would hamper adequate biomarker evaluation. • The tissue sections used for staining must have been cut within the 12-month cut-slide stability (CSS) window as applicable at the time of staining
Exclusion criteria
Exclusion criteria: A specimen will be excluded from the study if any of the following criteria are true: • It is a cytology sample including fine needle aspiration and body fluids. • It is a decalcified bone specimen. • It was fixed in 95% alcohol or PREFER.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| In the drug–companion diagnostic (CDx) co-development model, the clinical performance of the CDx device is considered acceptable if the biomarker-associated pharmaceutical study efficacy endpoint(s) are met.The primary endpoint described in BI Study 1438-0011 study protocol will also serve as the primary endpoint of this Dx study. Therefore, the primary endpoint for this diagnostic study is the overall survival (OS) in DLL3-positive patients treated with investigational product in combination with carboplatin and etoposide compared to those receiving carboplatin and etoposide alone. OS is defined as the time from randomization until death from any cause.The primary endpoint analysis of the Dx study will be performed during the study in alignment with BI 1438-0011. An interim analysis will occur as described in BI 1438-0011 study protocol.The results of these efficacy analyses will be summarized in the Dx Clinical Study Report associated with this protocol. | — |
Secondary
| Measure | Time frame |
|---|---|
| The following additional staining performance endpoints will be assessed at the patient level among all patients whose DLL3 screening specimens were tested with VENTANA DLL3 (SP347) RxDx Assay under this Dx protocol:Initial and final staining acceptability ratesInitial and final tissue morphology acceptability ratesInitial and final background acceptability ratesThere are no pre-determined acceptance criteria associated with these additional endpoints. | — |
Countries
Argentina, Australia, Austria, Belgium, Brazil, Canada, China, Czech Republic, Denmark, Finland, France, Germany, Ireland, Italy, Japan, Mexico, Netherlands, New Zealand, Norway, Poland, Portugal, South Korea, Spain, Sweden, Taiwan, United States
Contacts
Public ContactI Kirste
Ventana Medical Systems, Inc (Roche Tissue Diagnostics; RTD)
Outcome results
None listed