A Phase III Study of HS-20093 Injection Combined With Adebrelimab Versus Docetaxel in Previously … (NCT07464327) | Clinical Trial Compass
Not Yet RecruitingPhase 3
A Phase III Study 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
450 participantsStarted 2026-03-31
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. 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.
✓. Eastern Cooperative Oncology Group performance status (ECOG PS) score of 0 to 1.
✓. Minimum life expectancy \>12 weeks.
✓. Adequate organ function.
✓. Absence of the following active infectious diseases: hepatitis B, hepatitis C, human immunodeficiency virus (HIV) infection, tuberculosis, or syphilis.
Exclusion criteria
✕. Prior pathological diagnosis of mixed non-small cell lung cancer or any transformed non-small cell lung cancer.
✕. Prior or ongoing treatment with any of the following:
✕. 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.;
What they're measuring
1
Progression-free survival (PFS) assessed by Blinded Independent Central Review (BICR)
Timeframe: Approximately 3 years after the fist patient with first dose
2
Overall survival (OS)
Timeframe: Approximately 5 years after the fist patient with first dose
✕. Prior treatment with docetaxel monotherapy or in combination with other agents.
✕. Persistent adverse reactions caused by prior treatment.
✕. Untreated brain metastases; uncontrolled brain metastases; presence of leptomeningeal or brainstem metastases; presence of spinal cord compression (identified by radiographic imaging, regardless of symptoms).