This is a multicenter, randomized, open-label, controlled phase II clinical study to evaluate the efficacy and safety of HS-20093 injection combined with adebrelimab versus HS-20093 injection 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 II clinical study to evaluate the efficacy and safety of HS-20093 injection combined with adebrelimab versus HS-20093 injection 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 (HS-20093 injection). Participants in the experimental arm will receive intravenous infusions of HS-20093 and adebrelimab until disease progression or other treatment discontinuation criteria are met. Participants in the control arm will receive HS-20093 injection 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
76
The patient will be treated with HS-20093.
The patient will be treated with Adebrelimab
Objective Response Rate (ORR)
Objective Response Rate (ORR) assessed by investigator per RECIST v1.1
Time frame: Up to 3 years
Progression-Free Survival (PFS)
2\. Progression-Free Survival (PFS) assessed by investigator per RECIST v1.1
Time frame: Approximately 3 years
duration of response (DoR)
DoR assessed by investigator per RECIST v1.1
Time frame: Approximately 3 years
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
Adverse event (AE) and serious adverse event (SAE)
Incidence and severity of AEs and SAEs
Time frame: 3 years
Changes from baseline in cardiac function [electrocardiogram (ECG)]
Changes from baseline in cardiac function \[electrocardiogram (ECG)\]. For all ECGs performed during the study, the following parameters will be recorded and assessed: cardiac rhythm, heart rate, PR interval, RR interval, QRS duration, and QT interval (with QTcF correction using Fridericia's formula). A global interpretation of the ECG tracing will also be provided.
Time frame: 3 years
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