MedTrace Logo

Osimertinib Resistance in Patients With Non-small-cell Lung Carcinoma That Have Progressed.

NCT04737382 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2023-10-10

No results posted yet for this study

Summary

Initially, patients with EGFR mutation positive NSCLC respond well to osimertinib, a third generation EGFR tyrosine kinase inhibitor (TKI), but eventually progress. Upon progression multiple resistance mechanisms have been described and new therapeutic strategies are being developed to target these resistance mechanisms. Thorough and complete osimertinib resistance analysis enables optimal treatment decision making and might identify new targets for molecular treatment, thereby potentially improving patient outcome.

Conditions

  • Non-small-cell Lung Carcinoma

Interventions

DIAGNOSTIC_TEST

biopsy

The formalin fixed material will be processed for molecular analysis in a clinically validated diagnostic pipeline according to ISO 15189 or other acceptable standard

DIAGNOSTIC_TEST

ctDAN analysis

ctDNA analysis will be performed using the AVENIO ctDNA targeted kit according to the guidelines from the manufacturer with respect to isolation, library preparation and bioinformatics analysis.

Sponsors & Collaborators

  • AstraZeneca

    collaborator INDUSTRY

  • The Netherlands Cancer Institute

    lead OTHER

Principal Investigators

  • J de Langen, MD, PhD · The Netherlands Cancer Institute-Antoni van Leeuwenhoek

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-08-22
Primary Completion
2024-08-22
Completion
2024-08-22

Countries

  • Netherlands

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04737382 on ClinicalTrials.gov