The T790M mutation is highly sensitive to osimertinib, which is approved in this setting following failure of gefitinib, erlotinib or afatinib. In contrast to first- and second-generation EGFR TKIs, no predominant resistance mechanism to first-line osimertinib has been clearly defined yet. The most common mechanisms of resistance were c-MET amplification only for 15% of patients and the emergence of the EGFR C797S mutation in 7%, while \> 60% of patients were still with no identifiable mechanisms of resistance. As a result, targeted treatment options following first-line osimertinib failure remain limited. Thus, interest on sequential administration of EGFR TKIs in patients with EGFR mutation-positive NSCLC has been growing. So, here in this study, we intend to investigate treatment outcome (TOT) along with the several treatment options starting from the first line EGFR TKI treatment to various second line treatments including 3rd generation TKI and chemotherapy and others.
Study Type
OBSERVATIONAL
Enrollment
737
This is non-interventional, multi-center, multi-cohort study based on existing data from EGFR sensitizing mutation-positive NSCLC patients treated with afatinib as the first-line treatment. Enrolled patients will be categorized into four cohorts (cohort A, B, C and D) according to the type of second line treatment with biopsy results before start of second line treatment.
Jin Hyoung Kang
Seoul, South Korea
Total TOT
the time on treatment (total TOT) of EGFR M+ NSCLC patients treated with afatinib in the first-line (TOT-1) followed by second line treatments(TOT-2) including osimertinib, chemotherapy and other treatments.
Time frame: Non-interventional study (NIS) based on the existing data from patients' medical records(2013-08-01 ~ 2029-04-30).
objective response rate (ORR-1 & ORR-2's)
Time frame: Non-interventional study (NIS) based on the existing data from patients' medical records(2013-08-01 ~ 2029-04-30).
overall survival time
Time frame: Non-interventional study (NIS) based on the existing data from patients' medical records(2013-08-01 ~ 2029-04-30).
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