To evaluate the performance of the GRAIL NSCLC ctDNA Assay when used to identify patients with stage I adenocarcinoma NSCLC who are ctDNA positive as part of the screening process for the clinical study TROPION-Lung12.
ID
Source
Brief title
Condition
- Respiratory tract neoplasms
Synonym
Research involving
Sponsors and support
Intervention
- In-vitro diagnostic
N.a.
Outcome measures
Primary outcome
<p>This clinical performance study is intended to establish diagnostic clinical utility for the assay in stage I adenocarcinoma NSCLC.</p>
Secondary outcome
<p>Not applicable</p>
Background summary
This clinical performance study assesses the performance of the GRAIL Assay in a Phase III, randomized, open-label, multicentre, global study, assessing the efficacy and safety of Dato-DXd in combination with rilvegostomig compared with standard of care (SoC), following complete tumour resection, in participants with Stage I adenocarcinoma NSCLC who are ctDNA-positive as determined by the GRAIL Assay or have at least one high-risk pathologic feature.
Study objective
To evaluate the performance of the GRAIL NSCLC ctDNA Assay when used to identify patients with stage I adenocarcinoma NSCLC who are ctDNA positive as part of the screening process for the clinical study TROPION-Lung12.
Study design
This clinical performance study assesses the performance of the GRAIL Assay in a Phase III, randomized, open-label, multicentre, global study, assessing the efficacy and safety of Dato-DXd in combination with rilvegostomig compared with standard of care (SoC), following complete tumour resection, in participants with Stage I adenocarcinoma NSCLC who are ctDNA-positive as determined by the GRAIL Assay or have at least one high-risk pathologic feature.
Intervention
The GRAIL NSCLC ctDNA Assay is an investigational device intended to identify Stage I adenocarcinoma NSCLC patients who are ctDNA-positive as an eligibility criteria for the TROPION-Lung12 trial.
CAUTION – this test is for performance study only.
Study burden and risks
What are the possible risks? (from ICF)
The tests and assessments on this study are considered safe. But there may be some risks or discomforts. We will do everything we can to try to keep you safe while you are in the study.
Study Test Risks
· Blood Draw Discomforts: You may have pain or a bruise, and rarely skin infection, where they put the needle. You may feel lightheaded or dizzy after the blood draw.
Investigational IVD Risks
Because this test is experimental, there is a small chance of an incorrect result. For example:
· The test result may show positive, when it should be negative. This is a false positive.
· The test result may show negative, when it should be positive. This is called a false negative.
A false negative or positive may lead to:
· Not being able to take part in the study, when you may have been eligible.
· Taking part in the study when you are not eligible. This may lead to study drug side effects or other harm.
There is a small chance that your results may take longer than expected. The sponsor has plans in place to prevent delays. There is a small chance that the test doesn't work and gives an invalid result. If this happens you may be asked to give another sample for testing.
Genetic Testing Risks
The sponsor has protections in place to keep your data, samples, and results private. But there may be a low risk that you could be identified from the results of the genetic test.
Jeff Catania
O'Brien Drive 1525
Menlo Park 94025
United States
833-694-2553
grail-tropion-lung12-studyteam@grailbio.com
Jeff Catania
O'Brien Drive 1525
Menlo Park 94025
United States
833-694-2553
grail-tropion-lung12-studyteam@grailbio.com
Trial sites in the Netherlands
Listed location countries
Age
Inclusion criteria
Clinical inclusion criteria are the responsibility of the Pharmaceutical Partner, AstraZeneca. Briefly, participants with clinical Stage I NSCLC are eligible for screening with the GRAIL Assay using a pre-surgical blood specimen. Blood specimens are inspected at GRAIL to ensure adequate condition for subsequent testing according to the following criteria.
Inclusion Criteria:
● sample blood volume ≥ 3 mLs
● appropriate labeling of the tubes
● sample collected in Streck blood collection tubes
● sample collection tubes used within their expiration date
● sample received within 7 days after collection
● sample matches test requisition form (TRF) description
The GRAIL NSCLC ctDNA assay result is used in conjunction with additional data to determine participant eligibility for randomisation to a treatment arm in the clinical study TROPION-Lung12.
Exclusion criteria
Exclusion criteria:
● sample blood volume less than 3 mLs
● severe hemolysis of the blood sample
● inadequate labeling of the tubes
● expired sample collection tubes
● sample received outside of allowed 7 day testing window
● sample received damaged and cannot be used
● unresolvable differences between sample and TRF description
Design
Recruitment
Medical products/devices used
IPD sharing statement
Plan description
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 |
|---|---|
| Research portal | NL-009232 |