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EGFR_IUO 3.20 Clinical Study ...

EGFR_IUO 3.20 Clinical Study Protocol

Last Updated: 2024-01-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

Study Classification

INTERVENTIONAL

Study Start Date

2023-09-30

Study Completion Date

2023-12-18

Brief Summary

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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)

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Detailed Description

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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.

Conditions

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NSCLC

Study Design

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Allocation Method

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Specimens from NSCLC patient with FFPE FNA samples, will be extracted and tested with the Idylla EGFR\_IUO/3.20.

Interventions

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Idylla EGFR_IUO/3.20 Mutation Test

Clinical Performance Study Protocol for Idylla EGFR\_IUO/3.20 Mutation Test The EGFR\_IUO/3.20 is automated on the Idylla™ Platform, which executes the entire process from sample to result including sample liquefaction, cell lysis, real-time PCR amplification/detection, and data analysis and reporting.

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers