This is an open-label, multi-centre, single-arm study assessing the efficacy and safety of osimertinib as adjuvant treatment in stage IB-IIIB (8th AJCC) NSCLC with uncommon EGFRm after receiving complete surgical resection with or without adjuvant chemotherapy.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
51
Subjects successfully enrolled into the study will receive 80mg osimertinib QD p.o. until completion of planned treatment duration, recurrence of disease, or other treatment discontinuation criteria is met. The maximum treatment duration period is 3 years.
Research Site
Beijing, China
Research Site
Chengdu, China
Research Site
Chengdu, China
Research Site
Fuzhou, China
3-year disease-free survival (DFS) rate by investigator assessment
DFS is defined as the time from the first dosing of study treatment until the date of disease recurrence by investigator assessment or death by any cause in the absence of disease recurrence. DFS rate at 3 years is defined as the proportion of patients alive and disease free at 3 years from the first dosing of study treatment as estimated by Kaplan-Meier method, respectively. Patients who are disease-free and alive at the time of analysis will be censored at the date of their latest follow-up assessment known to be disease-free
Time frame: Up to 3 years for each subject from the first dosing of study treatment.
DFS rate at 2 years
DFS is defined as the time from the first dosing of study treatment until the date of disease recurrence by investigator assessment or death by any cause in the absence of disease recurrence. DFS rate at 2 years is defined as the proportion of patients alive and disease free at 2 years from the first dosing of study treatment as estimated by Kaplan-Meier method, respectively. Patients who are disease-free and alive at the time of analysis will be censored at the date of their latest follow-up assessment known to be disease-free.
Time frame: Up to 2 years for each subject from the first dosing of study treatment.
DFS rate at 5 years
DFS is defined as the time from the first dosing of study treatment until the date of disease recurrence by investigator assessment or death by any cause in the absence of disease recurrence. DFS rate at 5 years is defined as the proportion of patients alive and disease free at 5 years from the first dosing of study treatment as estimated by Kaplan-Meier method, respectively. Patients who are disease-free and alive at the time of analysis will be censored at the date of their latest follow-up assessment known to be disease-free.
Time frame: Up to 5 years for each subject from the first dosing of study treatment.
OS rate at 2 years
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Research Site
Guangzhou, China
Research Site
Kunming, China
Research Site
Ningbo, China
Research Site
Shijiazhuang, China
Research Site
Suzhou, China
Research Site
Tianjin, China
OS (Overall survival) is defined as the time from the first dosing of study treatment to the date of death from any cause; OS rate at 2 years is defined as the proportion of patients alive at 2 years from the first dosing of study treatment; Following disease recurrence, patients will be followed up for survival every 24 weeks until study completion
Time frame: Up to 2 years for each subject from the first dosing of study treatment.
OS rate at 3 years
OS (Overall survival) is defined as the time from the first dosing of study treatment to the date of death from any cause; OS rate at 3 years is defined as the proportion of patients alive at 3 years from the first dosing of study treatment; Following disease recurrence, patients will be followed up for survival every 24 weeks until study completion
Time frame: Up to 3 years for each subject from the first dosing of study treatment.
OS rate at 4 years
OS (Overall survival) is defined as the time from the first dosing of study treatment to the date of death from any cause; OS rate at 4 years is defined as the proportion of patients alive at 4 years from the first dosing of study treatment; Following disease recurrence, patients will be followed up for survival every 24 weeks until study completion
Time frame: Up to 4 years for each subject from the first dosing of study treatment.
OS rate at 5 years
OS (Overall survival) is defined as the time from the first dosing of study treatment to the date of death from any cause; OS rate at 5 years is defined as the proportion of patients alive at 5 years from the first dosing of study treatment; Following disease recurrence, patients will be followed up for survival every 24 weeks until study completion
Time frame: Up to 5 years for each subject from the first dosing of study treatment.
Median DFS by investigator assessment (if applicable)
DFS is defined as the date from first dosing of study treatment until the date of disease recurrence by investigator assessment or death from any cause in the absence of disease recurrence.Patients will be evaluated for disease recurrence at 12 weeks, 24 weeks, relative to enrollment, and then every 24 weeks until recurrence or 5 years. It is important to follow the assessment schedule as closely as possible.
Time frame: Up to 5 years for each subject from the first dosing of study treatment.
DFS rate at 4 years
DFS is defined as the time from the first dosing of study treatment until the date of disease recurrence by investigator assessment or death by any cause in the absence of disease recurrence. DFS rate at 4 years is defined as the proportion of patients alive and disease free at 4 years from the first dosing of study treatment as estimated by Kaplan-Meier method, respectively. Patients who are disease-free and alive at the time of analysis will be censored at the date of their latest follow-up assessment known to be disease-free.
Time frame: Up to 4 years for each subject from the first dosing of study treatment.