Clinical trial · Interventional
A Phase II Study 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
A Multicenter, Randomized, Open-Label, Controlled Phase II Clinical Study Evaluating 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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 18, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260918-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Non-Small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Adebrelimab Injection | Drug | Adebrelimab | ALIAS |
| HS-20093 for Injection | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- HS-20093 and adebrelimab
- interventionNames
- Drug: HS-20093 for Injection
- Drug: Adebrelimab Injection
- type
- ACTIVE_COMPARATOR
- label
- HS-20093
- interventionNames
- Drug: HS-20093 for Injection
Primary outcomes (2)
- measure
- Objective Response Rate (ORR)
- timeFrame
- Up to 3 years
- description
- Objective Response Rate (ORR) assessed by investigator per RECIST v1.1
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Age ≥18 years at the time of informed consent form (ICF) signature, either sex. 2. 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. 3. Previously treated patients with histologically or cytologically confirmed diagnosis of advanced or metastatic non-squamous non-small cell lung cancer (nsq-NSCLC). 4. Presence of at least one measurable target lesion. 5. Eastern Cooperative Oncology Group performance status (ECOG PS) score of 0 to 1. 6. Minimum life expectancy \>12 weeks. 7. Adequate organ function. 8. Absence of the following active infectious diseases: hepatitis B, hepatitis C, human immunodeficiency virus (HIV) infection, tuberculosis, or syphilis. 9. Female participants with negative serum pregnancy test result within 7 days prior to first dose administration, or documentation of no pregnancy risk. Exclusion Criteria: 1. Prior pathological diagnosis of mixed non-small cell lung cancer or any transformed non-small cell lung cancer. 2. Prior or ongoing treatment with any of the following: 1. Prior or current treatment targeting B7-H3; 2. Prior or current treatment with topoisomerase I inhibitor agents, including antibody-drug conjugates with topoisomerase I inhibitor payloads, etc.; 3. Prior treatment with docetaxel monotherapy or in combination with other agents. 3. Persistent adverse reactions caused by prior treatment. 4. Untreated brain metastases; uncontrolled brain metastases; presence of leptomeningeal or brainstem metastases; presence of spinal cord compression (identified by radiographic imaging, regardless of symptoms). 5. History of other primary malignancies. 6. Presence of any of the following abnormal cardiac findings: 1. Evidence of currently clinically significant important arrhythmia or ECG abnormality; 2. Presence of risk factors causing QT interval prolongation or arrhythmic events. 7. Severe, uncontrolled, or active cardiovascular or cerebrovascular disease. 8. Severe or poorly controlled hypertension. 9. Severe or poorly controlled diabetes mellitus. 10. Clinically significant bleeding symptoms or significant bleeding tendency. 11. Severe infection. 12. History of severe arterial or venous thromboembolic events. 13. Known or suspected interstitial pneumonitis, immune-mediated pneumonitis, or radiation pneumonitis. 14. Participants with active or history of autoimmune disease with potential for recurrence. 15. Prior occurrence of severe or life-threatening immune-mediated adverse events.
References
Publications (0)
Data not yet available