EGFR T790M, Lung Cancer Stage IV
Conditions
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.
Interventions
DRUGLazertinib
160mg po qd
Sponsors
Samsung Medical Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The dose reduction or treatment discontinuation rate | Total 24 months of study period | Dose who received dosage below 160mg or discontinued due to the adverse event |
Countries
South Korea
Outcome results
None listed