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Lazertinib 160mg in EGFR T790M NSCLC

Primary Purpose

Lung Cancer Stage IV, EGFR T790M

Status
Not yet recruiting
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Lazertinib
Sponsored by
Samsung Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lung Cancer Stage IV

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Samsung Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Lazertinib 160mg arm

Arm Description

Outcomes

Primary Outcome Measures

The dose reduction or treatment discontinuation rate
Dose who received dosage below 160mg or discontinued due to the adverse event

Secondary Outcome Measures

Full Information

First Posted
January 17, 2023
Last Updated
January 26, 2023
Sponsor
Samsung Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT05701384
Brief Title
Lazertinib 160mg in EGFR T790M NSCLC
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
February 1, 2023 (Anticipated)
Primary Completion Date
January 31, 2024 (Anticipated)
Study Completion Date
January 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Samsung Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer Stage IV, EGFR T790M

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
117 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Lazertinib 160mg arm
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Lazertinib
Intervention Description
160mg po qd
Primary Outcome Measure Information:
Title
The dose reduction or treatment discontinuation rate
Description
Dose who received dosage below 160mg or discontinued due to the adverse event
Time Frame
Total 24 months of study period

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Samsung Medical Center
City
Seoul
State/Province
MA
ZIP/Postal Code
06351
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
The only clinical outcome data will be published

Learn more about this trial

Lazertinib 160mg in EGFR T790M NSCLC

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