EGFR Positive Non-small Cell Lung Cancer
Conditions
Keywords
Non-small cell lung carcinoma, EGFR mutation, Tyrosine Kinase Inhibitor, Osimertinib, EGFR T790M
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.
Interventions
None listed
Sponsors
AstraZeneca
Thoraxklinik-Heidelberg gGmbH
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Fraction of EGFR+ NSCLC patients with sequential TKI treatment | 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
| Measure | Time frame | Description |
|---|---|---|
| Progression-free survival (PFS) | 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 |
| Time-to-next-treatment (TNT) | 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 |
| Time-to-chemotherapy (TTC) | 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 |
| Overall survival (OS) | 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 |
Countries
Germany
Outcome results
None listed