The primary objective of this study is to evaluate the clinical performance of the [REDACTED] PD-L1 [REDACTED] CDx Assay in terms of its ability to identify patients with squamous metastatic NSCLC (mNSCLC) who may benefit from treatment with […
ID
Source
Brief title
Condition
- Other condition
- Respiratory and mediastinal neoplasms malignant and unspecified
Synonym
Health condition
Non-Small-Cell-Lung Cancer (NSCLC)
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 outcome
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
Background summary
RD007122 study is a multicenter interventional clinical performance study with
an In-vitro Diagnostic Device (IVD), more specifically a Companion Diagnostic
Device (CDx). The IVD will be used to support patient screening for a
pharmaceutical clinical trial that is running in parallel and which is
sponsored by the pharma partner [REDACTED].
As the performance study involves a companion diagnostic (CDx), IVDR article
58(2) sentence 1 applies. The PD-L1 test result is one of the enrollment
criteria of the pharmaceutical study and testing will be performed on archival
or newly acquired NSCLC tumor specimens from patients undergoing screening for
enrollment into the pharmaceutical study. Therefore, the study falls under IVDR
article 58(1a,b).
The IVD *[REDACTED] PD-L1 [REDACTED] CDx Assay is a qualitative
immunohistochemical assay for assessment of the programmed death ligand 1
(PD-L1) protein in formalin-fixed paraffin-embedded (FFPE) non-small cell lung
cancer (NSCLC) tissue specimens.
RD007122 study will evaluate the performance of the IVD as a CDx to identify
patients with squamous NSCLC who may benefit from treatment with rilvegostomig
alone or in combination therapy, under the above-referred pharmaceutical trial.
The device is CE-marked, however it is not CE-marked or approved by any health
authority for the intended use being evaluated under the conduct of the
clinical performance study.
Samples from approximately 1760 patients will be stained to achieve a targeted
enrollment of
approximately 880 patients into the [REDACTED]-study. A PD-L1 tumor cell (TC)
expression level >=1% (PD-L1 TC >=1%), as determined by the [REDACTED] PD-L1
[REDACTED] CDx Assay, will be required for [REDACTED] study enrollment, meaning
that the investigational device results will be used for patient selection. In
this context, this is an interventional clinical performance study, where the
investigational [REDACTED] PD-L1 [REDACTED] CDx Assay is being used as a
companion diagnostic (CDx) device to identify squamous mNSCLC patients who may
benefit from treatment with the investigational therapy in the clinical trial.
In addition, [REDACTED] will be one of the stratification factors to randomize
patients into treatment arms.
Study objective
The primary objective of this study is to evaluate the clinical performance of
the [REDACTED] PD-L1 [REDACTED] CDx Assay in terms of its ability to identify
patients with squamous metastatic NSCLC (mNSCLC) who may benefit from treatment
with [REDACTED] in combination with platinum-based chemotherapy, as part of
clinical trial [REDACTED].
An additional objective of this Dx protocol is to evaluate the performance of
[REDACTED] PD-L1 [REDACTED] CDx Assay in staining FFPE NSCLC samples on the
[REDACTED] instrument in a clinical use setting.
Study design
As defined by the European Medical Device Coordination Group, [REDACTED] is
considered a drug (Rx)-diagnostic (Dx) combined trial, which is the
simultaneous evaluation of the efficacy and safety of an investigational
medicinal therapy ([REDACTED] in combination with platinum-based doublet
chemotherapy) and the performance evaluation of an investigational in vitro
diagnostic (IVD), ie, the [REDACTED] PD-L1 [REDACTED] CDx Assay. As part of the
co-development process, [REDACTED], as the IVD device manufacturer and sponsor
of the clinical performance study for the IVD device, will be responsible for
the use of the [REDACTED] PD-L1 [REDACTED] CDx Assay within the [REDACTED]
pharmaceutical trial. This Dx protocol (D205557) describes the [REDACTED] PD-L1
[REDACTED] CDx Assay testing procedures of samples from patients undergoing
enrollment screening for the trial at Dx central testing sites, as well as the
overall framework for the IVD performance evaluation, including objectives,
study design, endpoints, and acceptance criteria. A PD-L1 tumor cell (TC)
expression level >=1% (PD-L1 TC >=1%), as determined by the
[REDACTED] PD-L1 [REDACTED] CDx Assay, will be required for [REDACTED] study
enrollment, meaning that the investigational device results will be used for
patient selection. In this context, this is an interventional clinical
performance study, where the investigational [REDACTED] PD-L1 [REDACTED] CDx
Assay is being used as a companion diagnostic (CDx) device to identify squamous
mNSCLC patients who may benefit from treatment with the investigational therapy
in the clinical trial. In addition, [REDACTED] will be one of the
stratification factors to randomize patients into treatment arms.
Intervention
Lung biopsies will be obtained in the framework of the pharmaceutical study.
Study burden and risks
Collection of tissue samples is considered part of standard clinical practice
in this tumor indication to enable diagnostic testing in order to determine the
most appropriate therapeutic option. If a new tumor biopsy is needed to enable
investigational PD-L1 testing, the tissue will be obtained using a medically
routine sampling procedure. Patients will only undergo a new biopsy when risks
are considered medically appropriate by their treating physicians. Note that
the risk of a patient experiencing at least one complication during the biopsy
procedure is ~10%. The mortality rate for elective surgical lung biopsy for
patients with interstitial lung disease is <2%.
The risks to patients in both studies include false-positive results,
false-negative results, delayed
results, unevaluable results/loss of patient sample, and confidentiality
breaches.
[REDACTED] [REDACTED]
[REDACTED] [REDACTED]
US
[REDACTED] [REDACTED]
[REDACTED] [REDACTED]
US
Listed location countries
Age
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
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
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 | NL87758.000.24 |