The primary objective of the clinical performance study is to demonstrate the clinical performance of VENTANA PD-L1 (SP263) CDx Assay in terms of its ability to identify NSCLC patients who may benefit from treatment with volrustomig plus…
ID
Source
Brief title
Condition
- Metastases
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
- Progression free survival (PFS) in the PD-L1 TC <1% population. PFS is
defined as the time from randomization until radiological progression per
RECIST 1.1 as assessed by blinded independent central review (BICR), or death
due to any cause (in the absence of progression)
- Overall survival (OS) in the PD-L1 TC <1% population. OS is defined as the
time from randomization until the date of death due to any cause
Secondary outcome
- PFS in all randomized participants (PD-L1 TC <50%)
- OS in all randomized participants (PD-L1 TC <50%)
Background summary
The current state of the art in medicine for the target population under
investigation in AstraZeneca Study eVOLVE-Lung02 is immunotherapy (i.e,
anti-PD-[L]1 therapy), administered alone or in combination with standard of
care chemotherapy. There is a subset of patients (namely, the PD-L1 TC
<50% population) where current approved immunotherapies alone or in combination
have limited therapeutic effect, underlying the need for improved
therapeutic options for this patient population. Preclinical and clinical data
suggest there is synergy between PD-(L)1 inhibition and CTLA-4 inhibition and
that the clinical benefit from this combination is seen amongst patients with
PD-L1 TC <50%.
As part of a co-development paradigm including both an investigational therapy
and an investigational IVD device, RTD, as the IVD device
manufacturer, will be responsible for certain aspects of the investigational
IVD use within AstraZeneca Study eVOLVE-Lung02. As such, this protocol
supports AstraZeneca Study eVOLVE-Lung02 by describing the procedures for how
the patient tumor samples, collected as part of AstraZeneca Study
eVOLVE-Lung02, should be tested prospectively with VENTANA PD-L1 (SP263) CDx
Assay at the Dx testing sites.
Study objective
The primary objective of the clinical performance study is to demonstrate the
clinical performance of VENTANA PD-L1 (SP263) CDx Assay in terms of its ability
to identify NSCLC patients who may benefit from treatment with volrustomig plus
chemotherapy. PD-L1 expression level of NSCLC tumor
specimens will be determined for patient selection (TC <50%) and stratification
(PD-L1 TC <1% versus PD-L1 TC 1% to 49%) in support of AstraZeneca Study
eVOLVE-Lung02.
Study design
VENTANA PD-L1 (SP263) CDx Assay will be used to assess the PD-L1 expression
level of NSCLC tumor specimens collected from patients who are
being screened to determine eligibility to participate in AstraZeneca Study
eVOLVE-Lung02. It is anticipated that tumor specimens from approximately
1800 subjects undergoing screening to participate in AstraZeneca Study
eVOLVE-Lung02 will be tested with VENTANA PD-L1 (SP263) CDx Assay at
Dx testing sites.
Stained slides from each case will be interpreted by qualified pathologists who
will assign a PD-L1 expression level at the 1% TC (<1% versus >=1%) and at the
50% TC (<50% versus >=50%) thresholds. A PD-L1 expression level at <50% TC will
be one of the factors used to determine eligibility for enrolling patients into
AstraZeneca Study eVOLVE-Lung02. Additionally, PD-L1 expression level at the 1%
TC threshold (<1% versus 1% to 49%) will be one of the stratification factors
used for randomization of patients into the treatment arms of AstraZeneca Study
eVOLVE-Lung02. For each case, a PD-L1 expression level will also be assigned at
the 25% TC threshold and both raw TC scores and raw immune cell (IC) scores
will be recorded for
exploratory purposes.
Intervention
If not present: a tumor biopsy is collected at screening
Study burden and risks
A new biopsy may have to be taken during screening if no or not enough tissue
is available.
Prinses Beatrixlaan 582
Den Haag 2595BM
NL
Prinses Beatrixlaan 582
Den Haag 2595BM
NL
Listed location countries
Age
Inclusion criteria
1. It must be an FFPE tumor specimen submitted for AstraZeneca Study
eVOLVE-Lung02 under appropriate patient informed consent and processed in
accordance with standard practice;
2. It must contain sufficient 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 investigational essay if any
of the following conditions apply:
1. It was known to be fixed in alcohol-formalin-acetic acid (AFA), 95% alcohol
or any other alcohol-based fixative, or;
2. It consists of tissue that has been decalcified;
3. It is a fine needle aspirate or cytology specimen; or
4. Cut slides were prepared over 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 | NL84913.000.23 |