NCT04930133

Retrospective Multi-cohort Study of Frontline Afatinib Followed by 2nd Line Therapy Including Osimertinib, Chemotherapy or Other Therapy

Totality Outcome of Afatinib Sequential Treatment in Patients With EGFR Sensitizing Mutation-positive NSCLC in South Korea

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 737 (actual)
• Sponsor: Seoul St. Mary's Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• NSCLC

Interventions

Type	Name	Description
DRUG	Gilotrif	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.

Timeline

• Start date: 2020-02-24
• Primary completion: 2020-12-17
• Completion: 2021-09-30
• First posted: 2021-06-18
• Last updated: 2021-06-18

Locations

1 site across 1 country: South Korea