EGFR_IUO 3.20 Clinical Study Protocol

Biocartis

Status: Withdrawn

Conditions: NSCLC

Treatments: Device: Idylla EGFR_IUO/3.20 Mutation Test

Study type: Interventional

Funder types: Industry

Identifiers

NCT05959473

BC-020066

Details and patient eligibility

About

An interventional, prospective clinical performance study protocol, for the testing of DNA extracted from FFPE Fine needle aspirate samples, using the Idylla EGFR_IUO/3.20, from patients with Non-Small Cell Lung Cancer screened in AstraZeneca's NeoADAURA clinical trial (Protocol No. D516AC00001)

Full description

This is a prospective, interventional diagnostic study using the For Investigational Use Only EGFR_IUO/3.20 for FFPE FNA sections. Screened patients with available FNA specimens, collected per SoC, who are found to have exon 19 deletions or L858R mutations in the EGFR gene based on the results of EGFR_IUO/3.20 and who meet all other study eligibility criteria will be randomized into one of three arms of the NeoADAURA study: neoadjuvant osimertinib as monotherapy or in combination with pemetrexed/platinum chemotherapy, versus pemetrexed/platinum chemotherapy plus placebo.

The use of the investigational IVD does not require invasive sampling that is not part of standard of care (SoC). Investigational testing for patient selection will be performed on FFPE FNA specimens, obtained as SoC for diagnosis and/or pathologic staging prior to definitive surgery. By using available specimens obtained as SoC, there is no risk to patients as a result of invasive sampling for EGFR testing.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• All patients who provided consent (by signing and dating the Consent Form for AstraZeneca NeoADAURA Protocol No. D516AC00001), may be included in the device study.

Exclusion criteria

• Patients whose FFPE FNA samples are not Clinical Trial Assay evaluable will be excluded from the study.
• Patients with samples identified for the study which have insufficient testing material will also be excluded.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)