EGFR_IUO 3.20 Clinical Study Protocol

NSCLC Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT05959473
• Other study ID #: BC-020066
• Status: Withdrawn
• Phase: N/A
• Start date: September 2023
• Est. completion date: December 18, 2023

Study information

• Verified date: January 2024
• Source: Biocartis NV
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 18, 2023
• Est. primary completion date: December 18, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• NSCLC

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Biocartis NV	AstraZeneca

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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