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NCT05701384 Clinical Trial

Lazertinib 160mg in EGFR T790M NSCLC

Lung Cancer Stage IV Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT05701384
Other study ID # SMC 2023-01-17
Secondary ID
Status Not yet recruiting
Phase Phase 2
First received
Last updated
Start date February 1, 2023
Est. completion date January 31, 2025

Study information
Verified date January 2023
Source Samsung Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 117
Est. completion date January 31, 2025
Est. primary completion date January 31, 2024
Accepts healthy volunteers No
Gender All
Age group 19 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Drug:
• Lazertinib
160mg po qd

Locations
Country Name City State
Korea, Republic of Samsung Medical Center Seoul MA

Sponsors (1)
Lead Sponsor Collaborator
Samsung Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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
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