This double-blind, randomized, placebo-controlled, multicenter, Phase III study is designed to evaluate the efficacy and safety of ensatinib compared with placebo as adjuvant treatment in ALK positive stage II-IIIB non-small cell lung cancer after surgical resection with or without chemotherapy.
This is a double-blind, randomized, placebo-controlled, multicenter, Phase III study, the primary endpoint is disease-free survival. Participants in the experimental arm will receive Ensatinib at 225 mg orally once a day taken with or without food for 2 years. Participants in the control arm will receive placebo at 225 mg orally once a day taken with or without food for 2 years. Treatments will continue until disease recurrence, meeting one of treatment discontinuation criteria (eg, patient decision, adverse event, pregnancy), or achieving a maximum treatment duration of 2 years, whichever occurs earlier. At the time of treatment discontinuation, participants will enter a survival follow-up until death, withdrawal of consent or study closure, whichever occurs earlier.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
202
Ensartinib 225 mg once daily until disease recurrence or up to 2 years, whichever occurs earlier.
Placebo 225 mg once daily until disease recurrence or up to 2 years, whichever occurs earlier.
TianJin Medical University Cancer Institute & Hospital
Tianjin, China
RECRUITINGDisease free survival (DFS)
From date of randomization until date of tumor recurrence or death, whichever occurs earlier
Time frame: up to 5 years
DFS rate at 3 years
Time frame: Assessed at 3 years
DFS rate at 5 years
Time frame: Assessed at 5 years
Overall survival (OS)
Time frame: Assessed at 5 years
OS rate at 5 years
Time frame: up to 5 years
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