HS-20093 with Adebrelimab vs HS-20093 alone in advanced non-squamous NSCLC

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a multicenter, randomized phase II trial in adults with previously treated advanced or metastatic non-squamous NSCLC without actionable genomic alterations. Participants are randomized 1:1 to receive HS-20093 with adebrelimab or HS-20093 alone, administered by IV infusion until disease progression or other stopping criteria. The study aims to compare efficacy and safety between the combination and HS-20093 alone. Efficacy and safety follow-up are conducted per the protocol to determine potential benefits and risks. Eligible patients generally have measurable disease, ECOG 0-1, adequate organ function, and no active infections.

Why it matters

Who can join: the full rules

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.

Where it's running

• Tongji Hospital, Affiliated to Tongji Medical College of Huazhong University of Science and Technology
  Wuhan, Hubei, China Recruiting

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.