Lazertinib in Patients With NSCLC With Asymptomatic or Mild Symptomatic Brain Metastases After Failure of EGFR TKI.
- Conditions
- Lung Neoplasms
- Interventions
- Drug: lazertinib(YH25448)
- Registration Number
- NCT05326425
- Lead Sponsor
- Jin Hyoung Kang
- Brief Summary
This is an open-label, single-intervention, multicenter clinical trial in patients with non-small cell lung cancer with asymptomatic or mildly symptomatic brain metastases after failure of EGFR TKI treatment. The objective of this study is as follows.
* Primary objective : intracranial objective response rate (iORR) with RECIST 1.1
* Secondary objectives : intracranial progression free survival(iPFS), Intracranial objective response rate in T790M negative, isolated CNS progression patient group, overall Objective Rsponse Rate(ORR), duration of response(DoR), disease control rate(DCR), treatment failure pattern): intracranial progression or extracranial progression or both, salvage intracranial treatment rate, safety and tolerability
- Detailed Description
Patients who eligible the inclusion/exclusion criteria should take lazertinib 240 mg (80 mg, 3 tablets) once a day at the same time as possible on an empty stomach before meals. One cycle of treatment is defined as 42 days of continuous administration, and the tumor response by RECIST 1.1 will be evaluated every 1 cycle for the 1st, 2nd, 3rd, and 4th evaluation, and every 2 cycles from the 5th evaluation thereafter. .
If the investigator decides to reduce the dose due to an adverse drug reaction during the administration of lazertinib 240 mg, the dose may be reduced to 160 mg (80 mg, 2 tablets) of lazertinib.
Efficacy and safety will be evaluated by administering lazertinib 240 mg to patients with measurable brain metastasis or newly confirmed metastatic non-small cell lung cancer after failure of treatment with gefitinib, erlotinib, or afatinib after EGFR mutation is confirmed.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 40
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description lazertinib(YH25448) lazertinib(YH25448) lazertinib 240mg, once a day, oral, before disease progression
- Primary Outcome Measures
Name Time Method Intracranial objective response rates (iORR) (RECIST1.1) From date of the first administration until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months iORR will be evaluated according to RECIST v1.1 after IP administration and Response data will be used for the primary endpoint.
- Secondary Outcome Measures
Name Time Method intracranial progression free survival, iPFS Up to 2 years the date of onset of objective intracranial disease progression or death of any cause, whichever occurs first.
iORR in T790M negative, isolated CNS progression patient group From date of the first administration until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months iORR will be evaluated according to RECIST v1.1 after IP administration
overall ORR From date of the first administration until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months ORR will be evaluated according to RECIST v1.1 after IP administration.
duration of response, DoR Up to 2 years Duration from the date of the first documented confirmatory response(CR or PR) to the date of documented disease progression or death (equivalent to the date of the PFS event)
disease control rate, DCR Up to 2 years the percentage of subjects whose response is CR, PR, responding, or SD.
overall survival, OS Up to 2 years the period from the first administration of the investigational drug to the date of death from any cause.
treatment failure pattern From date of the first administration until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months intracranial progression or extracranial progression or both
salvage intracranial treatment rate Up to 2 years the percentag of subjects who received salvage treatment(surgery or radiation therapy) due to intracranial disease progression.
Trial Locations
- Locations (6)
Seoul National University Bundang Hospital
🇰🇷Gyeonggi-do, Korea, Republic of
Korea University Anam Hospital
🇰🇷Seoul, Korea, Republic of
Seoul St. Mary's Hospital, Catholic University of Korea
🇰🇷Seoul, Korea, Republic of
Gachon University Gil Medical Center
🇰🇷Incheon, Korea, Republic of
Yonsei University Health System, Severance Hospital
🇰🇷Seoul, Korea, Republic of
Seoul National University Hospital
🇰🇷Seoul, Korea, Republic of