Efficacy and Safety of 80mg Osimertinib in Patients With Non-small Cell Lung Cancer(NSCLC)

Sponsor
Samsung Medical Center
Study ID
NCT04563871
Phase
PHASE2
Status
Completed

Conditions

  • Non-small Cell Lung Cancer (NSCLC)

Eligibility Criteria

Sex
ALL
Age
19 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 80mg Osimertinib — DRUG
    One tablet of 80mg Osimertinib for oral administration per day

Study Details

This will be a Phase II, open-label, single-arm, multicenter study of the efficacy and safety of osimertinib (80 mg orally once daily) in patients with LM associated with EGFRm+ NSCLC.

Key Dates

Start date
Nov 17, 2020
Status verified
Jan 2026
Primary completion
Oct 25, 2023
Completion
Oct 25, 2023

Study Design

Enrollment
73 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: 80mg Osimertinib
    One tablet of 80mg Osimertinib for oral administration per day

Primary Outcome Measure

Overall survival [ Time Frame: Up to 30 months ]

Related Studies