This is a prospective, multi-center, single-arm, phase 2 study aiming to assess the efficacy and safety of adjuvant use of Ensartinib in stage IB-IIIA non-small cell lung cancer (NSCLC) with positive ALK-fusion. Enrolled patients will take Ensatinib for 3 years or until recurrence of the disease or intolerable toxicity, following complete tumour resection with or without adjuvant standard chemotherapy.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
80
Ensartinib 225mg oral daily for 3 years or until recurrence of the disease or intolerable toxicity
Jun Feng Liu
Shijiazhuang, Hebei, China
RECRUITING3-year disease free survival rate (DFSR)
Defined as the percentage of patients alive and disease free at 3 years
Time frame: 3 years
5-year overall survival rate
Defined as the percentage of patients alive at 5 years
Time frame: 5 years
disease free survival (DFS)
Defined as the time from the date of starting treatment until the date of disease recurrence or death (by any cause in the absence of recurrence)
Time frame: Up to 5 years
overall survival (OS)
Defined as the time from starting treatment to death.
Time frame: Up to 5 years
Adverse Events
The safety and tolerability profile of Ensartinib
Time frame: Up to 3 years
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