This trial is Phase II Trial of Lazertinib+Pemetrexed/Carboplatin in Patients with EGFR Sensitizing Mutation Positive Recurrent or Metastatic Non-Small Cell Lung Cancer Failed to prior lazertinib.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
87
Combination of lazertinib 240 mg (80 mg, 3 tablets) and pemed-S + carboplatin. Once a day lazertinib 240 mg pemed-S: 500mg/m2 q3w carboplatin: AUC5 q3w (only administered up to 4 cycles)
Yonsei University Health System, Severance Hospital
Seoul, South Korea
Progression-free survival, PFS
PFS is defined as the period from the date of administration of the first clinical trial drug to the progression of the disease or death for any reason. The progression-free survival period is analyzed for groups that can be evaluated for validity.
Time frame: End of trial (approximately 3 years)
Overall Survival, OS
Overall Survival, OS The overall survival period (OS) is evaluated based on the date of administration of the drug for the first clinical trial and the state of survival at the time of analysis. The total survival period is defined as the period from the date of administration of the first clinical trial drug to the date of death regardless of the cause. The entire survival period is analyzed for the safety analysis group. The total duration of survival is presented in a graph of Kaplan-Meier. Summarize the number of events, median values (calculated in Kaplan Meier graphs), and the percentage of test subjects whose events have not occurred in the 6th, 12th, and 18th months. Death, survival tracking, tracking failures, and the number and percentage of test subjects who withdrew consent are properly summarized.
Time frame: End of trial (approximately 3 years)
Objective Response Rate, ORR
Objective Response Rate, ORR) ORR is defined as the percentage of test subjects whose confirmed response was (RECIST 1.1) at least one full response (Complete Response, CR) or partial response (Partial Response, PR) before evidence of disease progression appears. The objective response rate is summarized for groups that can be evaluated for validity. The objective response rate is presented with a 95% confidence interval on both sides (assuming a normal distribution).
Time frame: End of trial (approximately 3 years)
Duration of Response, DoR
Duration of response (Duration of Response, DoR) DoR is defined as the time of occurrence from the date on which a later confirmed reaction was first recorded to the date on which the disease progress was recorded or the date of death (the same as the date of occurrence of the PFS event). The start of the reaction is defined as the most recent visit date identified as the first visit response PR or CR. If the disease has not progressed after the test subject has reached the reaction, the duration of the reaction is calculated using the time of PFS intermediate amputation. The duration of the response is analyzed for the sub-group of subjects who are CR/PR whose best overall response is confirmed among the groups that can be evaluated for validity.
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Time frame: End of trial (approximately 3 years)
Disease Control Rate, DCR
Disease control rate (Disease Control Rate, DCR) The disease control rate (DCR) is defined as the Best Overall Response (BOR), and the percentage of test subjects whose extracranial and intracranial responses are CR, PR, responding, or SD. The disease control rate is summarized for groups that can be evaluated for efficacy. The disease control rate is presented with a 95% confidence interval on both sides (assuming normal distribution).
Time frame: End of trial (approximately 3 years)
Treatment failure pattern
Treatment failure pattern (Treatment failure pattern) For the pattern of treatment failures, both intracranial disease progression (Intracranial progression) and non-cranial disease progression (Extracranial progression) are divided into progress and recorded and analyzed. Patterns of treatment failure and overall survival following locoregional failure or distant metastasis. It will be checked through RECIST every 8 weeks, confirmed as RECIST 1.1. Overall survival is analyzed in the safety analysis group. Overall survival is presented as a Kaplan-Meier graph.
Time frame: End of trial (approximately 3 years)