This is a multicenter, phase II study. The purpose of this study is to evaluate the safety and preliminary anti-tumor activity of SKB571 in patients with advanced non-small cell lung cancer. Eligible subjects will receive SKB571 monotherapy, until radiographic disease progression, intolerable toxicity, discontinuation of study treatment required by the subject, or other protocol-specified treatment discontinuation criteria, whichever occurs first.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
295
SKB571 for injection is administered every 3 weeks(Q3W) until radiographic disease progression,intolerable toxicity, or other protocol-specified treatment discontinuation criteria, whichever occurs first.
Sun Yat-Sen University Cancer Center
Guangzhou, China
NOT_YET_RECRUITINGHenan Cancer Hospital
Zhengzhou, China
RECRUITINGAE
Incidence and severity of adverse events (AEs)
Time frame: Up to 24 months
ORR
Objective response rate (ORR) (assessed by the investigators as per RECIST v1.1)
Time frame: Up to 24 months
PFS
Time from start of treatment to progression of disease (PD) or death, whichever occurs first, in patients with tumors.
Time frame: Up to 24 months
DOR
Time from the start of the first assessment of CR or PR in tumor patients to PD or death due to any reason.
Time frame: Up to 24 months
OS
Time from start of treatment to death due to any reason.
Time frame: Up to 24 months
DCR
Disease control rate (DCR) (assessed by the investigators as per RECIST v1.1)
Time frame: Up to 24 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.