- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05701384
Lazertinib 160mg in EGFR T790M NSCLC
January 26, 2023 updated by: Jong-Mu Sun, Samsung Medical Center
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
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 Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
117
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
MA
-
Seoul, MA, Korea, Republic of, 06351
- Samsung Medical Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
19 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Lazertinib 160mg arm
|
160mg po qd
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
Total 24 months of study period
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
February 1, 2023
Primary Completion (Anticipated)
January 31, 2024
Study Completion (Anticipated)
January 31, 2025
Study Registration Dates
First Submitted
January 17, 2023
First Submitted That Met QC Criteria
January 26, 2023
First Posted (Actual)
January 27, 2023
Study Record Updates
Last Update Posted (Actual)
January 27, 2023
Last Update Submitted That Met QC Criteria
January 26, 2023
Last Verified
January 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SMC 2023-01-17
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
IPD Plan Description
The only clinical outcome data will be published
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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