The objective of this CPS is to establish the clinical performance of F1CDx as a companion diagnostic (CDx) for AZD0022 in patients with NSCLC, CRC, or PDAC with a KRASG12D mutation. This CPSP will be executed in combination with the clinical trial…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
pancreatic ductal adenocarcinoma (PDAC), colorectal cancer (CRC), non-small cell lung cancer (NSCLC)
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary endpoint of the clinical trial D0780C00001 (ALAFOSS-01) is to
investigate the safety and tolerability, determine the MTD and/or OBD of
AZD0022 as monotherapy and in combination with anti-cancer agents in
participants with advanced tumours harbouring a KRASG12D mutation, as well as
to estimate the anti-tumour activity of AZD0022 as a monotherapy and in
combination with other anti-cancer agents. The same efficacy endpoint(s) will
be used to establish the clinical performance of F1CDx as a CDx for AZD0022 in
patients with NSCLC, CRC, or PDAC with a KRASG12D mutation who are most likely
to benefit from AZD0022 as monotherapy or in combination with other anti-cancer
agents. Data from this study may be used to support CDx approval from health
authorities to demonstrate the device is safe and effective for its intended
use.
The primary endpoint of the assessment of safety and tolerability, and the MTD
and/or OBD is to determine the incidence and severity of AEs/SAEs, incidence of
DLTs (Dose escalation), clinically significant changes in vital signs,
laboratory parameters, and ECG results, and discontinuation of AZD0022 due to
toxicity.
Efficacy endpoints of anti-tumour activity of AZD0022 as a monotherapy and in
combination with other anti-cancer agents are defined as Radiological response
evaluated according to RECIST v1.1 (ORR, CR rate, DoR, DCR, DRR, TTR, PFS, and
change in tumour size) and OS.
Secondary outcome
N/A
Background summary
In clinical trial D7080C00001 (ALAFOSS-01), AZD0022, a novel KRASG12D
inhibitor, will be administered as monotherapy and in combination with other
anti-cancer agents in patients with tumours harbouring a KRASG12D mutation. A
validated test is needed as a companion diagnostic (CDx) to identify patients
with NSCLC, CRC, or PDAC with a KRASG12D mutation who are most likely to
respond to AZD0022.
Study objective
The objective of this CPS is to establish the clinical performance of F1CDx as
a companion diagnostic (CDx) for AZD0022 in patients with NSCLC, CRC, or PDAC
with a KRASG12D mutation. This CPSP will be executed in combination with the
clinical trial D7080C00001 (ALAFOSS-01). Data from this study may be used to
support CDx approval from health authorities to demonstrate the product is safe
and effective for its intended use.
Study design
This is a clinical performance study (CPS) of F1CDx used as a clinical trial
assay (CTA) in the clinical trial D7080C00001 (ALAFOSS-01). FFPE tissues will
be shipped to the testing site where they will be screened for KRASG12D
mutation status to identify patients who may benefit from treatment with
AZD0022. This CPS is an interventional clinical performance study as defined in
point (46) of Article 2 of the IVDR, i.e., the test results may influence
patient management decisions and/or may be used to guide treatment.
Intervention
Blood sample will be collected during the pre-screening period. If not present:
tumor biopsy is collected as well.
Study burden and risks
A blood sample is taken during the pre-screening testing period and a new
biopsy may have to be taken if no or not enough tissue is
available. Collection of blood and tissue biopsy samples is considered part of
standard clinical practice.
Prinses Beatrixlaan 582
Den Haag 2595BM
NL
Prinses Beatrixlaan 582
Den Haag 2595BM
NL
Listed location countries
Age
Inclusion criteria
Sample Inclusion Criteria:
For the IVD study, this will include tumour tissue sent as part of the main
clinical trial that meets the central laboratory tissue sample quality
requirements.
All of the following requirements must be met for the sample to pass the
Foundation Medicine pathology review for processing with the F1CDx:
• Primary Specimen ID and Subject ID accompanying sample
• FFPE specimens, including tumour resections and core needle biopsies.
• Archival FFPE tumour samples from the most recently collected tumour tissue
sample, derived from the primary or recurrent cancer site.
• Optimal tissue volume of at least 0.6 mm3 or absolute minimum tissue volume
of 0.2 mm3
• Final percent tumour nuclei of at least 20% (optimally 30% or greater)
• Sufficient cellularity - determined by Foundation Medicine, Inc. pathologist
discretion.
• 10 x 4 micron sections on positively charged slides, minimum of 3 consecutive
slides
Exclusion criteria
Sample Exclusion Criteria:
• Fine-needle aspirates (FNA) and effusion cytology samples/other sample types
agreed with study team are NOT accepted.
• Sample is fixed in anything other than 10% NBF (e.g. Bouins, B5, Holland*s,
zinc buffered formalin).
• Samples baked above 37 degrees Celsius.
• Blocks larger than 30 x 25 mm cannot be processed.
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 | NL88312.000.24 |