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EGFR_IUO 3.20 Clinical Study Protocol

Sponsor
Biocartis NV (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT05959473
Collaborator
AstraZeneca (Industry)
130
Enrollment
9
Anticipated Duration (Months)

Study Details

Study Description

Brief 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)

Condition or Disease Intervention/Treatment Phase
  • Device: Idylla EGFR_IUO/3.20 Mutation Test
 N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
130 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Masking Description:
Specimens from NSCLC patient with FFPE FNA samples, will be extracted and tested with the Idylla EGFR_IUO/3.20.
Primary Purpose:
Diagnostic
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
Anticipated Study Start Date :
Sep 1, 2023
Anticipated Primary Completion Date :
Mar 1, 2024
Anticipated Study Completion Date :
Jun 1, 2024

Outcome Measures

Primary Outcome Measures

  1. Primary Outcome Measure [7 business days]

    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)

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Biocartis NV
  • AstraZeneca

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Biocartis NV
ClinicalTrials.gov Identifier:
NCT05959473
Other Study ID Numbers:
  • BC-020066
First Posted:
Jul 25, 2023
Last Update Posted:
Jul 25, 2023
Last Verified:
Jul 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
Yes

Study Results

No Results Posted as of Jul 25, 2023