The PACIFIC study established the standard of care for immunotherapy consolidation after chemoradiotherapy (CRT) in patients with unresectable stage III non-small cell lung cancer (NSCLC). However, its benefit is limited in patients with driver gene mutations. The LAURA study established a new paradigm of targeted consolidation therapy after CRT for patients with EGFR mutations. Although retrospective data support the efficacy of ALK-TKIs, no randomized controlled trial (RCT) has clearly demonstrated the value of ALK-TKI maintenance therapy after CRT. This study adopts a multicenter, randomized, double-blind, placebo-controlled design aimed at evaluating the efficacy and safety of ensartinib in patients with ALK-positive unresectable stage III NSCLC.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
45
225mg once daily, until disease progression, unacceptable toxicity or other discontinuation criteria are met
225mg once daily, until disease progression, unacceptable toxicity or other discontinuation criteria are met
progressive free survival
disease progression according to RSCIST v1.1 or intolerable toxicity according to CTCAE v5.0
Time frame: From enrollment to the end of treatment, up to 100 months
Objective Response Rate
ORR is defined as the proportion of participants whose best overall response is complete response (CR) or partial response (PR) as assessed by the investigator according to RECIST 1.1
Time frame: From first dose of study drug until disease progression, assessed up to approximately 12 months
Disease Control Rate
DCR is defined as the proportion of participants achieving a best overall response of complete response (CR), partial response (PR), or stable disease (SD) as assessed by the investigator according to RECIST 1.1
Time frame: From first dose of study drug until disease progression, assessed up to approximately 12 months
Overall Survival (OS)
OS is defined as the time from randomization until death due to any cause.
Time frame: From randomization until death from any cause, up to 120 months
Central Nervous System Progression-Free Survival (CNS-PFS)
CNS-PFS is defined as the time from randomization to the first documented intracranial progression (as assessed by MRI ) or death from any cause, whichever occurs first.
Time frame: From randomization until CNS progression or death, up to 100 months
Incidence of Adverse Events (AEs)
AEs graded by CTCAE version 5.0
Time frame: Approximately up to 100 months
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