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Trial Title:
Lazertinib 160mg in EGFR T790M NSCLC
NCT ID:
NCT05701384
Condition:
Lung Cancer Stage IV
EGFR T790M
Conditions: Official terms:
Lung Neoplasms
Lazertinib
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Lazertinib
Description:
160mg po qd
Arm group label:
Lazertinib 160mg arm
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.
Criteria for eligibility:
Criteria:
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
Gender:
All
Minimum age:
19 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Samsung Medical Center
Address:
City:
Seoul
Zip:
06351
Country:
Korea, Republic of
Start date:
February 1, 2023
Completion date:
January 31, 2025
Lead sponsor:
Agency:
Samsung Medical Center
Agency class:
Other
Source:
Samsung Medical Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05701384
