This is a randomized, double-blind, placebo-controlled, multicenter phase III study to evaluate the efficacy and safety of CS1001 in subjects with locally advanced/unresectable (Stage III) non-small cell lung cancer that has not progressed after prior concurrent/sequential chemoradiotherapy.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
381
Participant will receive CS1001 monoclonal antibody 1200 mg by intravenous infusion every 3 weeks, for up to 24 months
Participant will receive CS1001 placebo by intravenous infusion every 3 weeks, for up to 24 months
Guangdong Provincial People's Hospital
Guangzhou, Guangdong, China
Progress Free Survival (PFS)
The primary endpoint is the PFS of CS1001 versus placebo (evaluated by blinded independent central review(BICR) according to response evaluation criteria in solid tumors RECIST v1.1).
Time frame: from the date of randomization to the first date of recorded progression or all-cause death, whichever comes first, assessed up to 30 months.
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