Lung Cancer squamous metastatic NSCLC
Conditions
Interventions
Lung biopsies will be obtained in the framework of the pharmaceutical study.
Sponsors
redacted
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: All tumor specimens submitted as part of [REDACTED] that also satisfy the inclusion criteria outlined below, will be tested with the [REDACTED] PD-L1 [REDACTED] CDx Assay. To be eligible for [REDACTED] PD-L1 [REDACTED] CDx Assay staining/interpretation under this protocol, a specimen must meet all of the following criteria: 1. It must be an FFPE NSCLC tumor specimen submitted from patients who were screened for enrollment into the [REDACTED] study; 2. It must be an FFPE tumor block processed in accordance with standard practice or unstained FFPE slides prepared from a such a tumor block if sufficient PD-L1 testing are available; and 3. It must contain sufficient tumor tissue for interpretation at the discretion of the reviewing pathologist Pleas refer to [REDACTED] to review pharmaceutical study population eligibility criteria.
Exclusion criteria
Exclusion criteria: A specimen will be excluded from staining with the investigational assay if any of the following conditions apply: 1. It is fixed in alcohol-formalin-acetic acid, 95% alcohol, or any other alcohol-based fixative, or PREFER; or 2. It is a fine needle aspirate or a cytology specimen; or 3. It consists of tissue containing bone that has been decalcified;* or 4. Cut slides were prepared from FFPE blocks beyond the cut-slide stability of 12 months prior to staining. *Prior to testing any bone 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 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. Patient exclusion criteria will be listed in the pharmaceutical protocol [REDACTED].
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| There will be 2 dual primary endpoints: - Overall survival (OS), defined as the time from randomization until the date of death due to any cause, among all randomized participants. - Progression-free survival (PFS), defined as the time from randomization until radiological progression [REDACTED], or death due to any cause (in the absence of progression), among all randomized participants. Note: These endpoints will be assessed by the pharmaceutical partner according to the [REDACTED] study protocol and the associated [REDACTED] Statistical Analysis Plan (SAP). As part of a combined study design approach, the efficacy and safety of the investigational therapy and the clinical performance of the investigational IVD device will be evaluated together. Given that the investigational [REDACTED] PD-L1 [REDACTED] CDx Assay will be used for patient selection, the same endpoints used to evaluate the efficacy of the investigational medicinal product will be used as the performance indicators to assess the clinical performance of the investigational IVD device for its intended purpose. Thus, the outcome data (primary efficacy endpoints) from the [REDACTED] study will also serve to validate the clinical performance of the [REDACTED] PD-L1 [REDACTED] CDx Assay as a companion diagnostic (CDx) device to identify squamous mNSCLC patients who may benefit from the [REDACTED] in combination with platinum-based doublet chemotherapy. | — |
Secondary
| Measure | Time frame |
|---|---|
| A secondary endpoint is not defined. Additionally, the following endpoints will be evaluated among all specimens collected as part of enrollment screening for [REDACTED] and tested with the [REDACTED] PD-L1 [REDACTED] CDx Assay: - Initial and final overall staining acceptability rate - Initial and final background acceptability rates - Initial and final tissue morphology acceptability rates | — |
Countries
Argentina, Australia, Austria, Belgium, Brazil, Canada, China, France, Germany, Hungary, India, Israel, Italy, Japan, Malaysia, Netherlands, Peru, Poland, South Korea, Spain, Taiwan, Thailand, Turkey, United Kingdom, United States, Vietnam
Contacts
Public ContactAN Njiena
Roche Diagnostics GmbH
Outcome results
None listed