The objectives of this study are to assess molecular testing, treatment patterns, and associated outcomes among patients with EGFR (Epidermal Growth Factor Receptor) mutation-positive locally advanced or advanced NSCLC (Non-Small Cell Lung Cancer) who have progressed on or after EGFR-TKI (EGFR-Tyrosine Kinase Inhibitor) therapy post availability of a third-generation TKI (primary study cohort). Additionally, molecular testing and treatment patterns will be assessed among a secondary cohort of patients which will include patients diagnosed with de-novo EGFR T790M mutation-positive locally advanced or advanced NSCLC.
Study Type
OBSERVATIONAL
Enrollment
169
Research Site
Aschaffenburg, Germany
Research Site
Augsburg, Germany
Research Site
Bad Kreuznach, Germany
Research Site
Ballenstedt, Germany
Research Site
Bautzen, Germany
Research Site
Berlin, Germany
To evaluate molecular testing patterns among patients with EGFR mutation-positive locally advanced or advanced NSCLC
Molecular testing patterns including: Molecular testing rate defined as the number of patients identified as having received molecular testing divided by the number of patients in the primary study cohort (applicable to patients in the primary study cohort); Change in testing rates over time - testing rate over time will be described; Molecular testing details including sample type, method of biopsy, testing turnaround time, test type, reason for testing, testing laboratory type, reason for not performing a test; Molecular testing results including mutation status and type, test outcome, histologic/phenotypic transformation;
Time frame: Date of enrollment in the study until end of follow-up or death if this occurs before, assessed approximately up to 36 months
To assess treatment patterns and associated clinical outcomes among patients with EGFR mutation-positive locally advanced or advanced NSCLC
Treatment patterns and associated clinical outcomes including: Overall survival measured from: date of initial diagnosis to date of death from any cause (for primary and secondary cohorts), date of progression to date of death from any cause (for primary cohort only); Time to initiation of new therapy defined as the time from start date of current therapy to start date of subsequent therapy; Treatment(s) received post diagnosis and post progression including chemotherapy, radiation, surgery, targeted therapy, immunotherapy; Treatment sequence patterns, line(s) of therapy, treatment regimen(s), treatment duration, number of cycles;
Time frame: Date of enrollment in the study until end of follow-up or death if this occurs before, assessed approximately up to 36 months
To assess health care utilization patterns
Health care utilization patterns will be presented by the following care settings: hospitalization and length of stay, emergency room and physician office visits
Time frame: Date of enrollment in the study until end of follow-up or death if this occurs before, assessed approximately up to 36 months
To assess treatment related complications
Assessment of treatment related complications observed with chemotherapy and targeted therapies among patients with NSCLC.
Time frame: Date of enrollment in the study until end of follow-up or death if this occurs before, assessed approximately up to 36 months
To assess biopsy related complications
Assessment of biopsy related complications for each documented biopsy procedure
Time frame: Date of enrollment in the study until end of follow-up or death if this occurs before, assessed approximately up to 36 months
To document rate of central nervous system (CNS) metastases
Time frame: Date of enrollment in the study until end of follow-up or death if this occurs before, assessed approximately up to 36 months
Assessment of health-related quality of life (HRQoL)
Health related quality of life (HRQoL): Assessment of general cancer-associated and specific lung cancer associated parameters by use of standardized HRQoL questionnaires: * European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire - Core 30 (EORTC QLQ-C30) * European Organisation For Research And Treatment Of Cancer Quality Of Life Questionnaire - Lung Cancer 13 (EORTC QLQ-LC13) (adminstered to patients included in primary study cohort)
Time frame: Date of first visit to last visit. HRQoL are collected every 6 months (plus or minus 1.5 months) up to 36 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Research Site
Bochum, Germany
Research Site
Bonn, Germany
Research Site
Bottrop, Germany
Research Site
Bremen, Germany
...and 63 more locations