Lazertinib for NSCLC Harboring Activating EGFR Mutations in TKI naïve Patients
- Sponsor
- Se-Hoon Lee
- Study ID
- NCT05463224
- Phase
- PHASE2
- Status
- Active Not Recruiting
Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 19 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Lazertinib group — DRUGLazertinib 240mg, Once, po, daily (1 cycle of 21 days)
Study Details
The primary objective is to evaluate the efficacy/safety of lazertinib and to explore the resistance mechanism of lazertinib as first-line in patients with NSCLC harboring activating EGFR mutations.
Key Dates
- Start date
- Jan 4, 2023
- Status verified
- Apr 2026
- Primary completion
- Dec 1, 2026
- Completion
- Dec 31, 2027
Study Design
- Enrollment
- 150 participants (actual)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: Lazertinib groupLazertinib 240mg daily (1 cycle of 21 days)
Primary Outcome Measure
progression-free survival [ Time Frame: through study completion, an average of 18.0 month ]
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