EGFR_IUO 3.20 Clinical Study Protocol

Idylla™ EGFR_IUO/3.20 Mutation Test a Clinical Trial Assay in the AstraZeneca Phase III NeoADAURA Clinical Trial (D516AC00001) Clinical Study Protocol

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)

Study Overview

• Status: Withdrawn
• Conditions: NSCLC
• Intervention / Treatment: Device: Idylla EGFR_IUO/3.20 Mutation Test

Detailed 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.

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Primary Outcome Measure	EGFR_IUO/3.20 as a screening test in Phase 3 of clinical trial (Protocol D516AC00001), in order to identify patients (with NSCLC) with EGFR mutation positive (Exon 19 deletion and/or L858R) for inclusion in study (D516AC00001)	7 business days

Collaborators and Investigators

• Sponsor: Biocartis NV
• Collaborators: AstraZeneca

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2023
• Primary Completion (Actual): December 18, 2023
• Study Completion (Actual): December 18, 2023

Study Registration Dates

• First Submitted: July 17, 2023
• First Submitted That Met QC Criteria: July 24, 2023
• First Posted (Actual): July 25, 2023

Study Record Updates

• Last Update Posted (Actual): January 26, 2024
• Last Update Submitted That Met QC Criteria: January 25, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: BC-020066

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes