Loading clinical trials...
Loading clinical trials...
Lazertinib for Patients With NSCLC Harboring Uncommon EGFR Mutations: A Single-arm, Phase II Multi-center Trial
The primary objective is to evaluate the antitumor efficacy of lazertinib in patients with NSCLC harboring uncommon EGFR mutations. The primary endpoint is objective response rate (ORR), defined as the proportion of patients achieving a complete response or partial response per RECIST v1.1 by investigator's assessments.Secondary endpoints are disease control rate, progression-free survival, overall survival, and duration of response. Secondary objectives are progression-free survival, overall survival, and safety profile according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. * Progression-free survival :From C1D1 to the date of either disease progression or death * Overall survival: From C1D1 to the date of all-cause mortality * Safety: Evaluated by NCI-CTCAE v5.0 * The exploratory objective is to identify the acquired resistance mechanism to lazertinib in NSCLC with uncommon EGFR mutation. Lazertinib 240mg daily (1 cycle of 21 days) will be applied to the all patients until documented evidence of disease progression, unacceptable toxicity, noncompliance, or withdrawal of consent, or the investigator decides to discontinue treatment, whichever comes first. However, beyond disease progression is allowed based on the investigator's decision. Doses should be taken approximately 24 hours apart at the same time point each day before eating meal under fasting. If it is more than 12 hours after the dose time, the missed dose should not be taken, and patients should be instructed to take the next dose at the next scheduled time.
Age
20 - No limit years
Sex
ALL
Healthy Volunteers
No
Yonsei University Health System, Severance Hospital
Seoul, South Korea
Start Date
April 1, 2022
Primary Completion Date
December 1, 2024
Completion Date
December 1, 2024
Last Updated
March 14, 2022
36
ESTIMATED participants
Lazertinib
DRUG
Lead Sponsor
Yonsei University
NCT06305754
NCT07486219
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT05098132