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OpenTrials
Completed

NCT Number: NCT04105153

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Thoraxklinik-Heidelberg gGmbH - Universitätsklinikum Heidelberg

Heidelberg, 69126, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • histologically confirmed locally advanced (stage III) and not suitable for definitive local treatment, or metastatic (stage IV) NSCLC
  • activating EGFR mutation confirmed
  • treatment with EGFR TKI

Exclusion criteria

none

Treatment and study plan

Primary outcomes

  1. Fraction of EGFR+ NSCLC patients with sequential TKI treatment

    Time frame: assessment will performed retrospectively for all study patients from September 2019 until June 2020

    • the rate of rebiopsy and molecular workup (especially T790M testing) at disease progression under treatment with first-/second-generation EGFR inhibitors
    • the frequency of T790M mutations in the molecular workup of patients with disease progression under first-/second-generation EGFR inhibitors
    • the actual rate of osimertinib implementation after failure of first-/second-generation EGFR inhibitors in the "real-world" setting.

Secondary outcomes

  1. Progression-free survival (PFS)

    Time frame: assessment will performed retrospectively for all study patients from September 2019 until June 2020

    Progression-free survival (PFS) of patients treated with first-/second-generation EGFR inhibitors and/or osimertinib in the real-world setting

  2. Time-to-next-treatment (TNT)

    Time frame: assessment will performed retrospectively for all study patients from September 2019 until June 2020

    Time-to-next-treatment (TNT) of patients treated with first-/second-generation EGFR inhibitors and/or osimertinib in the real-world setting

  3. Time-to-chemotherapy (TTC)

    Time frame: assessment will performed retrospectively for all study patients from September 2019 until June 2020

    Time-to-chemotherapy (TTC) of patients treated with first-/second-generation EGFR inhibitors and/or osimertinib in the real-world setting

  4. Overall survival (OS)

    Time frame: assessment will performed retrospectively for all study patients from September 2019 until June 2020

    Overall survival (OS) of patients treated with first-/second-generation EGFR inhibitors and/or osimertinib in the real-world setting

Sponsors and collaborators

Lead sponsor

Thoraxklinik-Heidelberg gGmbH

Other

Collaborators

  • AstraZeneca

Registry information

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Sep 26, 2019
Registry last updated
Nov 22, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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