Lazertinib 160mg in EGFR T790M NSCLC | NCT05701384

Studies
Lazertinib 160mg in EGFR T790M NSCLC

NCT05701384

Sponsor

Samsung Medical Center

Status

Unknown status

Last Update Posted

Jan 27, 2023Actual

Enrollment

117Estimated

Phase

Phase 2

Conditions

Lung Cancer Stage IV
EGFR T790M

Interventions

Lazertinib

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 1, 2023Estimated

Primary Completion Date

Jan 31, 2024Estimated

Completion Date

Jan 31, 2025Estimated

First Submitted Date

Jan 17, 2023

First Submission Date that Met QC Criteria

Jan 26, 2023

First Posted Date

Jan 27, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 26, 2023

Last Update Posted Date

Jan 27, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

117Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Lazertinib 160mg arm	Experimental		Drug: Lazertinib

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Lazertinib	Drug	160mg po qd	Lazertinib 160mg arm

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The dose reduction or treatment discontinuation rate	Dose who received dosage below 160mg or discontinued due to the adverse event	Total 24 months of study period

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Samsung Medical Center		Seoul	MA	06351	South Korea

IPD Sharing Statement Module

Plan to Share IPD

Description

The only clinical outcome data will be published

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D008175	Lung Neoplasms

Ancestor Terms

ID	Term
D012142	Respiratory Tract Neoplasms
D013899	Thoracic Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C000707992	lazertinib

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided