NCT05959473

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

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Biocartis NV · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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)

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.

Conditions

• NSCLC

Interventions

Type	Name	Description
DEVICE	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.

Timeline

• Start date: 2023-09-01
• Primary completion: 2023-12-18
• Completion: 2023-12-18
• First posted: 2023-07-25
• Last updated: 2024-01-26

Regulatory

• FDA-regulated device study