MedTrace Logo

Real-world Analysis of Workup at Disease Progression and Implementation of Osimertinib for EGFR+ NSCLC

NCT04105153 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 400

Last updated 2023-11-22

No results posted yet for this study

Summary

Tyrosine kinase inhibitors (TKI) have greatly improved prognosis of epidermal growth factor receptor (EGFR)-positive non-small cell lung cancer (NSCLC), with tumor responses in the majority of cases and a median overall survival currently exceeding 2.5 years. However, clinical courses vary widely and eventual treatment failure is inevitable. The most common resistance mechanism against first- and second-generation EGFR inhibitors is the EGFR T790M mutation, which emerges in about 50% of cases and is amenable to next-line treatment with the third-generation compound osimertinib. However, experience in everyday clinical practice shows that implementation of EGFR TKI sequencing is often problematic, for example because a considerable number of EGFR+ NSCLC patients failing first- and second-generation EGFR inhibitors do not undergo T790M mutation testing at the time of disease progression. This study will use patient records to analyze the clinical course of EGFR+ NSCLC patients treated with first- and second-generation EGFR inhibitors at the Thoraxklinik Heidelberg (Germany) during the past years. The main aim is to analyze the diagnostic and therapeutic measures, including implementation of osimertinib, taken at the time of disease progression as well as their effect on patient outcome in a real-world, routine clinical setting.

Conditions

  • EGFR Positive Non-small Cell Lung Cancer

Sponsors & Collaborators

  • AstraZeneca

    collaborator INDUSTRY

  • Thoraxklinik-Heidelberg gGmbH

    lead OTHER

Principal Investigators

  • Petros Christopoulos, MD · Thoraxklinik Heidelberg gGmbH - Universitätsklinikum Heidelberg

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-04-15
Primary Completion
2019-12-01
Completion
2019-12-01

Countries

  • Germany

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 NCT04105153 on ClinicalTrials.gov