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First-Line Osimertinib Therapy for Advanced EGFR Mutation-Positive NSCLC in Korea

First-Line Osimertinib Therapy for Advanced EGFR Mutation-Positive NSCLC in Korea

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
CRIS
Registry ID
KCT0010699
Enrollment
200
Registered
2025-07-01
Start date
2025-06-24
Completion date
Unknown
Last updated
2025-09-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

None listed

Sponsors

Yonsei University Health System, Severance Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Age of at least 19 years 2. Provision of informed consent 3. Pathologically confirmed non-small cell lung cancer (NSCLC) 4. Newly diagnosed, treatment-naive locally advanced or metastatic NSCLC that is not amenable to curative surgery or radiotherapy. This includes recurrent disease after curative surgery or definitive concurrent chemoradiation therapy(CCRT) for early-stage NSCLC. 5. Tumors must harbor Epidermal Growth Factor Receptor(EGFR) exon 19 deletion or L858R mutation, which is confirmed in tissue or plasma. 6. Patients whose tumor mutations are profiled using next-generation sequencing(NGS) at the time of diagnosis

Exclusion criteria

Exclusion criteria: 1. Prior treatment with an Epidermal Growth Factor Receptor-Tyrosine Kinase Inhibitor(EGFR-TKI). 2. Prior treatment with any systemic anti-cancer therapy for advanced NSCLC including standard chemotherapy, immunotherapy or any investigational therapy.

Design outcomes

Primary

MeasureTime frame
Progression-free survival (PFS)

Secondary

MeasureTime frame
Disease control rate (DCR);Duration of response (DoR);Objective response rate (ORR);Overall Survival (OS);Toxicity profile;Time to treatment discontinuation (TTD);Duration of Treatment

Countries

Korea, Republic of

Contacts

Public ContactEun Young Kim

Yonsei University Health System, Severance Hospital

narae97@yuhs.ac+82-2-2228-2268

Outcome results

None listed

Source: CRIS (via WHO ICTRP) · Data processed: Feb 4, 2026