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

Study Overview
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Brief Summary
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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.

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

Conditions
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EGFR Positive Non-small Cell Lung Cancer

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| TKI-treated advanced EGFR+ NSCLC<br>Patients with advanced EGFR-mutated non-small cell lung cancer treated with tyrosine kinase inhibitors | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fraction of EGFR+ NSCLC patients with sequential TKI treatment | 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. | assessment will performed retrospectively for all study patients from September 2019 until June 2020 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free survival (PFS) | Progression-free survival (PFS) of patients treated with first-/second-generation EGFR inhibitors and/or osimertinib in the real-world setting | assessment will performed retrospectively for all study patients from September 2019 until June 2020 | 
| Time-to-next-treatment (TNT) | Time-to-next-treatment (TNT) of patients treated with first-/second-generation EGFR inhibitors and/or osimertinib in the real-world setting | assessment will performed retrospectively for all study patients from September 2019 until June 2020 | 
| Time-to-chemotherapy (TTC) | Time-to-chemotherapy (TTC) of patients treated with first-/second-generation EGFR inhibitors and/or osimertinib in the real-world setting | assessment will performed retrospectively for all study patients from September 2019 until June 2020 | 
| Overall survival (OS) | Overall survival (OS) of patients treated with first-/second-generation EGFR inhibitors and/or osimertinib in the real-world setting | assessment will performed retrospectively for all study patients from September 2019 until June 2020 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Non-small cell lung carcinoma, EGFR mutation, Tyrosine Kinase Inhibitor, Osimertinib, EGFR T790M