This study is an open-label Phase II clinical trial to evaluate the safety and efficacy of SHR-A1921 or SHR-A2009 in patients with advanced NSCLC who progressed after standard therapy.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Treatment group: Subjects will receive an intravenous infusion of SHR-A2009 until confirmed progression, unaccepted toxicity, or any criterion for withdrawal from the study.
Treatment group: Subjects will receive an intravenous infusion of SHR-A1921 until confirmed progression, unaccepted toxicity, or any criterion for withdrawal from the study.
Henan cancer hospital
Zhengzhou, Henan, China
Overall response rate (ORR)
Assessed by Investigator According to RECIST v1.1
Time frame: up to 12 months
Progression-free survival (PFS)
Assessed by Investigator According to RECIST v1.1
Time frame: up to 12 months
overall survival (OS)
OS is the time from the date of first dose until the date of death by any cause.
Time frame: up to 24 months
Duration of response(DoR )
Assessed by Investigator According to RECIST v1.1
Time frame: up to 12 months
Disease control rate (DCR)
Assessed by Investigator According to RECIST v1.1
Time frame: up to 12 months
Time to Response (TTR)
Assessed by Investigator According to RECIST v1.1
Time frame: up to 12 months
The incidence and severity of adverse events (AEs)
Rated based on CTCAE V5.0
Time frame: from Day1 to 90 days after last dose
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