Clinical Performance Study Plan (CPSP) for the use of GenDx CDx Tedopi for subject enrollment on to the OSE Immunotherapeutics Phase 3 trial (OSE2101C302) of OSE2101 versus docetaxel in HLA-A*02 positive patients with metastatic Non-Small Cell Lung Cancer (NSCLC) and secondary resistance to immune checkpoint inhibitor (ARTEMIA)

Clinical Performance Study Plan (CPSP) for the use of GenDx CDx Tedopi for subject enrollment on to the OSE Immunotherapeutics Phase 3 trial (OSE2101C302) of OSE2101 versus docetaxel in HLA-A*02 positive patients with metastatic Non-Small Cell Lung Cancer (NSCLC) and secondary resistance to immune checkpoint inhibitor (ARTEMIA) - Use of GenDx CDx Tedopi for enrollment in OSE2101C302 (ARTEMIA study)

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON57031

Enrollment

Registered

2024-10-01

Start date

2024-12-30

Completion date

Unknown

Last updated

2025-08-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-small-cell lung cancer

Interventions

In-vitro diagnostic: GenDx CDx Tedopi, coupled to the &nbsp

IMP (OSE2101

Tedopi) of clinical trial ARTEMIA (EU CT: 2023-0509340-10-00).

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Subjects with squamous and non-squamous metastatic NSCLC with ICI secondary  resistance who may be eligible to ARTEMIA study (study code: OSE2101C302, EU CT number: 2023-0509340-10-00) will be eligible for  pre-screening of HLA-A*02 phenotype. - signed a specific pre-screening informed consent form.  - completed requisition form and Sample/Specimen ID no. - whole blood samples collected in tubes with ACD or EDTA as an anticoagulant - optimal purified DNA should have an A260/A280 ratio of 1.7 - 2.0 - optimal amount of template DNA to use for the ARTEMIA study is 60 ng in 1-3  ul. However an input range between 30 - 120 ng DNA can be safely used as input. - purified DNA sample stored according to procedure  If pre-screening shows that subjects are HLA-A*02 positive, additional  inclusion/exclusion criteria for the ARTEMIA study, will be checked to confirm  their eligibility to participate in the ARTEMIA study as per the ARTEMIA study  protocol

Exclusion criteria

Exclusion criteria: - wrongly collected or processed blood samples (e.g. heparinized collection tubes, deviation from processing procedure without possibility to repeat, loss or contamination of original sample - samples with insufficient testing material

Design outcomes

Primary

Measure	Time frame
The primary endpoint for this clinical performance study of the GenDx CDx Tedopi will be the primary endpoint of the ARTEMIA study which is Overall Survival (OS) defined as time from randomisation to death of any cause.	—

Countries

Belgium, Canada, France, Germany, Greece, Hungary, Italy, Netherlands, Poland, Portugal, Romania, Spain, United Kingdom, United States

Contacts

Public ContactE. C. E. Kremer Groot

Genome Diagnostics B.V; Tradename: GenDx

cdx@gendx.com0302523799

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)