Stage I Adenocarcinoma Non-small Cell Lung Cancer
Conditions
Interventions
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.
CAUT
Sponsors
GRAIL Inc.
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
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) descriptionThe 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: 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 outcomes
Primary
| Measure | Time frame |
|---|---|
| This clinical performance study is intended to establish diagnostic clinical utility for the assay in stage I adenocarcinoma NSCLC. | — |
Countries
Australia, Belgium, Brazil, Canada, China, France, Germany, Hungary, Italy, Japan, Malaysia, Netherlands, Poland, South Korea, Spain, Sweden, Switzerland, Taiwan, Turkey, United States, Vietnam
Contacts
Public ContactJeff Catania
GRAIL Inc.
Outcome results
None listed