Lazertinib 160mg in EGFR T790M NSCLC
- Sponsor
- Samsung Medical Center
- Study ID
- NCT05701384
- Phase
- PHASE2
- Status
- Unknown
Conditions
- EGFR T790M
- Lung Cancer Stage IV
Eligibility Criteria
- Sex
- ALL
- Age
- 19 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Lazertinib — DRUG160mg po qd
Study Details
The lazertinib is currently approved as 2nd line T790M mutation-positive NSCLC that failed from either 1st or 2nd generation EGFR TKI. The current recommended dosage is 240mg. Based on the promising clinical efficacy of the dose escalation study, this study is designed to evaluatee the clinical efficacy and safety of 160mg lazertinib.
Key Dates
- Start date
- Feb 1, 2023
- Status verified
- Jan 2023
- Primary completion
- Jan 31, 2024
- Completion
- Jan 31, 2025
Study Design
- Enrollment
- 117 participants (estimated)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: Lazertinib 160mg arm
Primary Outcome Measure
The dose reduction or treatment discontinuation rate [ Time Frame: Total 24 months of study period ]