This study compares the efficacy and safety of AK104 versus Sugemalimab as consolidation therapy in patients with unresectable, locally advanced NSCLC who have not progressed following concurrent or sequential chemoradiotherapy.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
560
AK104 ivgtt Q3W
1200mg Q3W
Cancer Hospital of Shandong First Medical University
Jinan, China
RECRUITINGProgression-free survival (PFS) assessed by INV
PFS is defined as the time from randomization until the first documentation of disease progression or death due to any cause, whichever occurs first (based on RECIST Version 1.1).
Time frame: 3 years
OS
Time from randomization to death
Time frame: 5 years
6-month PFS rate assessed by INV
PFS rate at 6 months
Time frame: 3 years
AEs
Adverse events incidence and severity, clinically significant abnormal laboratory test results.
Time frame: 3 years
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