Clinical trial NCT04105153: Real-world Analysis of Workup at Disease Progression and Implementation of Osimertinib for EGFR+ NSCLC
Official title: Real-world Analysis of Workup at Disease Progression and Implementation of Osimertinib for EGFR+ NSCLC
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: EGFR Positive Non-small Cell Lung Cancer
Keywords: Non-small cell lung carcinoma
EGFR mutation
Tyrosine Kinase Inhibitor
Osimertinib
EGFR T790M
Lead sponsor: Thoraxklinik-Heidelberg gGmbH
Sponsor class: OTHER
Collaborators: name: AstraZeneca
First posted: 2019-09-26
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All NSCLC patients with activating EGFR mutations treated with EGFR TKI at the Thoraxklinik Heidelberg between 2010 and 2019.

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Fraction of EGFR+ NSCLC patients with sequential TKI treatment
timeFrame: assessment will performed retrospectively for all study patients from September 2019 until June 2020
Secondary outcomes:
measure: Progression-free survival (PFS)
timeFrame: assessment will performed retrospectively for all study patients from September 2019 until June 2020
measure: Time-to-next-treatment (TNT)
timeFrame: assessment will performed retrospectively for all study patients from September 2019 until June 2020
measure: Time-to-chemotherapy (TTC)
timeFrame: assessment will performed retrospectively for all study patients from September 2019 until June 2020
measure: Overall survival (OS)
timeFrame: assessment will performed retrospectively for all study patients from September 2019 until June 2020
Other outcomes:
Locations:
city: Heidelberg
country: Germany
facility: Thoraxklinik-Heidelberg gGmbH - Universitätsklinikum Heidelberg
Study officials:
affiliation: Thoraxklinik Heidelberg gGmbH - Universitätsklinikum Heidelberg
name: Petros Christopoulos, MD
role: PRINCIPAL_INVESTIGATOR
References:
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