NCT05701384Not yet recruitingPhase 2
A Phase II Study for the Evaluation of the Feasibility of Lazertinib 160mg Per Day in Patients With EGFR T790M Mutant Non-small Cell Lung Cancer
Samsung Medical Center1 site in 1 country117 target enrollmentStarted: February 1, 2023Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Not yet recruiting
- Sponsor
- Samsung Medical Center
- Enrollment
- 117
- Locations
- 1
- Primary Endpoint
- The dose reduction or treatment discontinuation rate
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 19 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Pathologically confirmed non-small cell lung cancer
- •Patients in a palliative setting who is not applicable for the curative treatment
- •EGFR mutation positive patients who received previous 1st or 2nd generation EGFR TKI
- •Confirmed EGFR T790M mutation after the previous EGFR TKI
- •Available to receive lazertinib either as po or vis levine tube
- •Willing to participate clinical trial
- •Age over or equal to 19
- •ECOG PS 0 to 2
Exclusion Criteria
- •Previously received 3rd generation EGFR TKI
- •No clinical benefit is expected based on the investigator's decision
- •Uncontrolled symptomatic CNS metastases
- •Uncontrolled systemic disease
Arms & Interventions
Lazertinib 160mg arm
Experimental
Intervention: Lazertinib (Drug)
Outcomes
Primary Outcomes
The dose reduction or treatment discontinuation rate
Time Frame: Total 24 months of study period
Dose who received dosage below 160mg or discontinued due to the adverse event
Secondary Outcomes
No secondary outcomes reported
Investigators
Jong-Mu Sun
Professor
Samsung Medical Center
Study Sites (1)
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