The purpose of this study is to evaluate the safety, tolerability and objective response rate of SKB264 as combination with therapy in subjects with advanced or metastatic non-small cell lung cancer.
This is a multicenter, open-label study of SKB264 as combination therapy or monotherapy in subjects with NSCLC. Approximately 498 subjects will be enrolled in this study including around 88 subjects for the safety run-in period and 410 subjects for the expansion period.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
356
intravenous (IV) infusion (Q2W or Q3W)
intravenous (IV) infusion (400mg, Q6W)
intravenous (IV) infusion (AUC5, Q3W)
Safety and tolerability
Dose-limiting toxicity (DLT); Incidence and severity of adverse events (AEs); Discontinuation of study treatment due to AEs
Time frame: From subject sign the informed consent form (ICF) to 30 days after the last dose of study treatment, up to approximately 36 months
ORR
Objective response rate (ORR) per RECIST v1.1
Time frame: The proportion of subjects with a confirmed complete response (CR) or partial response (PR), up to approximately 36 months
Duration of response (DOR)
For subjects with a confirmed CR or PR, DOR is defined as the time from the first documented evidence of CR or PR until radiographic disease progression or death due to any cause, whichever occurs first
Time frame: From baseline until disease progression, death, or other protocol defined reason, up to approximately 36 months
Progression-free survival (PFS)
The time from first dose of study intervention to first documentation of radiographic disease progression or death due to any cause, whichever occurs first
Time frame: From baseline until disease progression, death, or other protocol defined reason, up to approximately 36 months
Overall survival (OS)
the time period from the start of study intervention to death due to any cause.
Time frame: From baseline until death due to any cause, up to approximately 36 months
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80mg, QD
Beijing Cancer Hospital
Beijing, Beijing Municipality, China
Chongqing University Cancer Hospital (Chongqing Cancer Hospital)
Chongqing, Chongqing Municipality, China
Fujian Cancer Hospital
Fuzhou, Fujian, China
Sun Yat-Sen University Cancer Center
Guangzhou, Guangdong, China
Sun Yatsen University Cancer Center Huangpu Hos
Guangzhou, Guangdong, China
Guangxi Cancer Hospital/ Guangxi Medical University Cancer Hospital
Nanning, Guangxi, China
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, China
The First Affiliated Hospital of Zhengzhou University(Heyi Compus)
Zhengzhou, Henan, China
Henan Cancer Hospital,Affiliated Cancer Hospital of Zhengzhou University
Zhengzhou, Henan, China
Zhongnan Hospital of Wuhan University
Wuhan, Hubei, China
...and 40 more locations