The objective of this study is to demonstrate the clinical performance of VENTANA PD-L1 (SP263) CDx Assay in terms of its ability to identify patients with metastatic NSCLC who may benefit from treatment with acasunlimab (GEN1046) in combination…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
Oncology - Non-Small Cell Lung Cancer
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 outcome
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.
Background summary
VENTANA PD-L1 (SP263) CDx Assay is a qualitative immunohistochemical assay
using rabbit monoclonal anti-PD-L1 clone SP263 intended for laboratory use in
the assessment of programmed death ligand 1 (PD-L1) protein in formalin-fixed,
paraffin-embedded (FFPE) non-small cell lung carcinoma (NSCLC) tissue specimens
by light microscopy.
The VENTANA PD-L1 (SP263) CDx Assay is used with the OptiView DAB IHC Detection
Kit for staining on a BenchMark IHC/ISH instrument.
VENTANA PD-L1 (SP263) CDx Assay is indicated as an aid in identifying NSCLC
patients who may benefit from treatment with acasunlimab in combination with
pembrolizumab.
Results of the VENTANA PD-L1 (SP263) CDx Assay should be interpreted by a
qualified pathologist in conjunction with histological examination, relevant
clinical information, and proper controls.
CAUTION: Investigational device. Limited by Federal (or United States) law to
investigational use.
Study objective
The objective of this study is to demonstrate the clinical performance of
VENTANA PD-L1 (SP263) CDx Assay in terms of its ability to identify patients
with metastatic NSCLC who may benefit from treatment with acasunlimab (GEN1046)
in combination with pembrolizumab after treatment with a PD-1/PD-L1 inhibitor
and platinum-containing chemotherapy.
Study design
This clinical performance study follows a combined trial approach, in which the
efficacy and safety of treatment with acasunlimab (GEN1046) in combination with
pembrolizumab and the clinical performance of the investigational VENTANA PD-L1
(SP263) CDx Assay will be evaluated simultaneously.
Intervention
lung biopsies will be obtained as part of the pharmaceutical study (in case no
archived sample is available)
Study burden and risks
Taking tissue biopsy samples is considered part of standard clinical practice
to determine the most appropriate therapeutic option for NSCLC patients.
Potential complications of a lung biopsy include blood loss or blood clots,
pain or discomfort, infection, pneumonia, collapsed lung, and bleeding from the
lung. In addition, there may be risks during the biopsy such as dizziness, mild
local pain, pressure or pain from the needle, pain or tenderness at the biopsy
site, swelling or redness, and scarring at the biopsy site. In rare cases, you
may develop an infection. Other unforeseen risks may occur.
There is also a risk of a false positive or false negative test result. In the
case of a false negative result, the patient may not have the opportunity to
receive a potential benefit from the study therapy, but may discuss alternative
treatment with their doctor. In addition, a false positive test result (i.e.,
incorrect assignment of a PD-L1 expression level >= 50% TC) may lead to
enrollment of a patient who would otherwise have been excluded. In this case,
the patient may be exposed to potential adverse side effects of the treatment
received in the study.
Innovation Park Drive 1910
Tucson AZ 85755
US
Innovation Park Drive 1910
Tucson AZ 85755
US
Listed location countries
Age
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
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
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL87815.000.24 |