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.
Age ≥18 years at the time of informed consent form (ICF) signature, either sex.
Be willing to participate in this clinical trial with understanding of study procedures, ability to provide written informed consent, and commitment to comply with all requirements specified in this clinical trial protocol.
Previously treated patients with histologically or cytologically confirmed diagnosis of advanced or metastatic non-squamous non-small cell lung cancer (nsq-NSCLC).
Presence of at least one measurable target lesion.
Prior pathological diagnosis of mixed non-small cell lung cancer or any transformed non-small cell lung cancer.
Prior or current treatment targeting B7-H3;
Prior or current treatment with topoisomerase I inhibitor agents, including antibody-drug conjugates with topoisomerase I inhibitor payloads, etc.;
Prior treatment with docetaxel monotherapy or in combination with other agents.
Parallel
HS-20093 for Injection
DrugThe patient will be treated with HS-20093.
Adebrelimab Injection
DrugThe patient will be treated with Adebrelimab
Objective Response Rate (ORR)
Objective Response Rate (ORR) assessed by investigator per RECIST v1.1
Progression-Free Survival (PFS)
2\. Progression-Free Survival (PFS) assessed by investigator per RECIST v1.1
duration of response (DoR)
DoR assessed by investigator per RECIST v1.1
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.
Adverse event (AE) and serious adverse event (SAE)
Incidence and severity of AEs and SAEs
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.
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options:
