This is a phase 3 double-blind, randomized, placebo-controlled, study to assess the efficacy and safety of Furmonertinib (AST2818) versus placebo in patients with stage II-IIIA non-small cell lung cancer (NSCLC) with centrally confirmed, most common sensitising EGFR mutations (Ex19Del and L858R) either alone or in combination with other EGFR mutations as confirmed by a central test, who have had complete tumour resection, with or without postoperative adjuvant chemotherapy.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
318
The initial dose of Furmonertinib 80 mg once daily
The initial dose of Furmonertinib 80 mg once daily
First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China
RECRUITINGDFS
Disease free survival
Time frame: From date of randomization until date of disease recurrence or death (by any cause in the absence of recurrence). Estimated median time to event of 60 months for those treatment) [ Time Frame: Up to 5 years]
Disease free survival (DFS) rate
Disease free survival (DFS) rate at 2, 3 and 5 years
Time frame: Time Frame: From date of randomization until date of disease recurrence or death (by any cause in the absence of recurrence)Estimated median time to event of 60 months for those treatment[ Time Frame: Up to 5 years]
Overall Survival (OS)
Defined as the time from the date of randomization until date of death due to any cause
Time frame: Time Frame: From date of randomization until date of death due to any cause Estimated median time to event of 60 months for those treatment[ Time Frame: Up to 5 years]
Overall Survival rate at 5 years
Defined as the proportion of patients alive at 5 years, estimated from a Kaplan Meier plot of OS at the time of the primary analysis
Time frame: Time Frame: From date of randomization until date of death due to any cause about 5years[ Time Frame: Up to 5 years]
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