This is a multicenter, randomized, open-label, controlled phase III clinical study to evaluate the efficacy and safety of HS-20093 injection combined with adebrelimab versus docetaxel in previously treated patients with advanced or metastatic non-squamous non-small cell lung cancer without actionable genomic alterations.
This is a multicenter, randomized, open-label, controlled phase III clinical study to evaluate the efficacy and safety of HS-20093 injection combined with adebrelimab versus docetaxel in previously treated patients with advanced or metastatic non-squamous non-small cell lung cancer without actionable genomic alterations. Eligible participants will be randomly assigned in a 1:1 ratio to the experimental arm (HS-20093 and adebrelimab) or the control arm (docetaxel injection). Participants in the experimental arm will receive intravenous infusions of HS-20093 and adebrelimab: HS-20093 at a dose of 8.0 mg/kg every 3 weeks (Q3W) until disease progression or other treatment discontinuation criteria are met; adebrelimab at a dose of 1200 mg Q3W until disease progression or other treatment discontinuation criteria are met. Participants in the control arm will receive docetaxel at a dose of 75 mg/m² Q3W until disease progression or other treatment discontinuation criteria are met. Efficacy and safety will be analyzed and evaluated in both arms following the protocol-specified follow-up procedures.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
450
Participants will receive intravenous infusions of HS-20093 and adebrelimab: HS-20093 at a dose of 8.0 mg/kg every 3 weeks (Q3W) until disease progression or other treatment discontinuation criteria are met; adebrelimab at a dose of 1200 mg Q3W until disease progression or other treatment discontinuation criteria are met.
Participants will receive docetaxel at a dose of 75 mg/m² Q3W until disease progression or other treatment discontinuation criteria are met.
Progression-free survival (PFS) assessed by Blinded Independent Central Review (BICR)
Progression-free survival (PFS) assessed by BICR per RECIST v1.1.
Time frame: Approximately 3 years after the fist patient with first dose
Overall survival (OS)
Overall Survival is defined as the time from the date of randomization to the date of participant's death due to any cause.
Time frame: Approximately 5 years after the fist patient with first dose
PFS assessed by investigator
PFS assessed by investigator per RECIST v1.1
Time frame: Approximately 3 years after the fist patient with first dose
Objective response rate (ORR)
Objective response rate (ORR) assessed by BICR and investigator per RECIST v1.1
Time frame: Approximately 3 years after the fist patient with first dose
Disease control rate (DCR)
Disease control rate (DCR) assessed by BICR and investigator per RECIST v1.1
Time frame: Approximately 3 years after the fist patient with first dose
Duration of response (DoR)
Duration of response (DoR) assessed by BICR and investigator per RECIST v1.1
Time frame: Approximately 3 years after the fist patient with first dose
Incidence and severity of AEs
Time frame: From the first dose until 90 days after the last dose
Incidence and severity of SAEs
Time frame: From the first dose until 90 days after the last dose
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