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

NCT04930133 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 737

Last updated 2021-06-18

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

Principal Investigators

  • Jin Hyoung Kang · Seoul St. Mary's Hospital, The Catholic University of Korea

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-02-24
Primary Completion
2020-12-17
Completion
2021-09-30

Countries

  • South Korea

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04930133 on ClinicalTrials.gov