This is a phase 2/3, multicenter, randomized, open, positive-controlled study of patients with advanced non-small cell lung cancer whose disease has progressed after prior anti-PD-(L)1 therapy. Subjects should have documented progressive disease during prior treatment with first- or second-line PD-(L)1 and platinum-containing dual-agent chemotherapy.Subjects will be randomized to two treatment groups in a 1:1 ratio. Treatment Group: KN046 5mg/kg Q3W + lenvatinib recommended for phase III dose (RP3D) every day. Control group: Docetaxel 75mg/m2 Q3W .
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
16
KN046 is 5 milligram per kilogram, every 3 weeks.
Lenvatinib is RP3D milligram per day, every day.
Docetaxel is 75 milligram per Square meter, every 3 weeks.
Shanghai Pulmonary Hospital
Shanghai, Shanghai Municipality, China
DLT
Dose limit toxicity (phase 2)
Time frame: 28 days or 21 days
OS
Overall survival (OS) was defined as the time from randomization to death due to any cause (phase 3).
Time frame: up to 2 years
PFS
Progression-free survival (PFS) was defined as the time from randomization grouping to the first documented disease progression or death from any cause as evaluated by the investigator according to RECIST 1.1 criteria (phase 3).
Time frame: up to 2 years
ORR
Objective response rate (ORR) based on the RECIST 1.1 by principal investigator
Time frame: up to 2 years
DCR
Disease control rate (DCR) based on the RECIST 1.1 by principal investigator
Time frame: up to 2 years
DOR
Duration of response (DOR) based on the RECIST 1.1 by principal investigator
Time frame: up to 2 years
CBR
Clinical benefit rate (CBR) based on the RECIST 1.1 by independent review committee
Time frame: up to 2 years
TTR
Time to response (TTR) based on the RECIST 1.1 by independent review committee
Time frame: up to 2 years
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