To assess the efficacy and safety of osimertinib in participants with EGFRm positive stage II-IIIB NSCLC, following complete tumour resection with or without adjuvant chemotherapy.
This is a phase 2 open-label study to assess the efficacy and safety of osimertinib in participants with stage II-IIIB NSCLC with sensitising EGFR mutations. The study is designed to evaluate 5 years of adjuvant osimertinib therapy.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
188
Participants will receive osimertinib (80 mg or 40 mg orally, once daily).
Estimate the Efficacy of Osimertinib as Measured by Disease Free Survival (DFS) [Common EGFRm Cohort].
Defined as time from date of first dose until disease recurrence, or death due to any cause in the absence of recurrence.
Time frame: From date of first dose until date of disease recurrence or death (by any cause in the absence of recurrence), up to approximately 5 years. Assessed at 5 years.
Disease Free Survival Rate at 3, 4 and 5 Years (Uncommon EGFRm Cohort)
Defined as the proportion of participants alive and disease free at 3, 4, and 5 years.
Time frame: From date of first dose until date of disease recurrence or death (by any cause in the absence of recurrence), up to approximately 5 years. Assessed at 3 years, 4 years, and 5 years.
DFS Rate at 3 and 4 Years (Common EGFRm Cohort)
Defined as the proportion of participants alive and disease free at 3, and 4 years.
Time frame: From date of first dose until date of disease recurrence or death (by any cause in the absence of recurrence), up to approximately 5 years. Assessed at 3 years, and 4 years.
Overall Survival (OS) [Common EGFRm Cohort]
Defined as time from date of first dose until the date of death due to any cause.
Time frame: From date of first dose until the date of death due to any cause, up to approximately 5 years. Assessed at 3 years, 4 years, and 5 years.
Safety and tolerability in overall population (Common EGFRm Cohort and Uncommon EGFRm Cohort)
Adverse Events (AEs) graded by CTCAE version 5.0.
Time frame: From date of first dose up to approximately 5 years
Recurrence events in overall population (Common EGFRm Cohort and Uncommon EGFRm Cohort)
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Research Site
Santa Rosa, California, United States
Research Site
Las Vegas, Nevada, United States
Research Site
White Plains, New York, United States
Research Site
Hong Kong, Hong Kong
Research Site
Hong Kong, Hong Kong
Research Site
Hong Kong, Hong Kong
Research Site
Avellino, Italy
Research Site
Brescia, Italy
Research Site
Lecce, Italy
Research Site
Milan, Italy
...and 46 more locations
Local/regional, or distant recurrence events assessed.
Time frame: From date of first dose up to approximately 5 years