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Non-Small Cell Lung CancerPhase 2NCT07824882

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 Phase 2 study testing HS-20093 for Injection and Adebrelimab Injection in people with Non-Small Cell Lung Cancer, run by Hansoh BioMedical R&D Company at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Non-Small Cell Lung Cancer
What is being tested?
HS-20093 for Injection and Adebrelimab Injection
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
76 participants
Where
1 siteChina
Study dates
8 Oct 2026to 30 Sep 2029
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • Adequate organ function.
  • Absence of the following active infectious diseases: hepatitis B, hepatitis C, human immunodeficiency virus (HIV) infection, tuberculosis, or syphilis.
  • Female participants with negative serum pregnancy test result within 7 days prior to first dose administration, or documentation of no pregnancy risk.

Who cannot join

  • 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.;
  • Prior treatment with docetaxel monotherapy or in combination with other agents.
  • Persistent adverse reactions caused by prior treatment.
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  • Untreated brain metastases; uncontrolled brain metastases; presence of leptomeningeal or brainstem metastases; presence of spinal cord compression (identified by radiographic imaging, regardless of symptoms).
  • History of other primary malignancies.
  • Presence of any of the following abnormal cardiac findings:
  • Evidence of currently clinically significant important arrhythmia or ECG abnormality;
  • Presence of risk factors causing QT interval prolongation or arrhythmic events.
  • Severe, uncontrolled, or active cardiovascular or cerebrovascular disease.
  • Severe or poorly controlled hypertension.
  • Severe or poorly controlled diabetes mellitus.
  • Clinically significant bleeding symptoms or significant bleeding tendency.
  • Severe infection.
  • History of severe arterial or venous thromboembolic events.
  • Known or suspected interstitial pneumonitis, immune-mediated pneumonitis, or radiation pneumonitis.
  • Participants with active or history of autoimmune disease with potential for recurrence.
  • Prior occurrence of severe or life-threatening immune-mediated adverse events.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

China1 site, 1 recruiting

  • Tongji Hospital, Affiliated to Tongji Medical College of Huazhong University of Science and Technology

    Wuhan, Hubei

    Qian Chu, MD, 86-027-83662640, qchu@hust.edu.cn

    Recruiting

Other trials in China

About this study

Official title: 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

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.

Read the detailed description

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.

Being tested
HS-20093 for Injection, Adebrelimab Injection
Keywords
Non-Small Cell Lung Cancer, HS-20093, B7H3, Antibody-Drug Conjugates, PD-L1 inhibitor
Medical subject headings
Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • HS-20093 for InjectionDrug

    Also called Risvutatug Rezetecan, Ris-Rez, GSK5764227

    The patient will be treated with HS-20093.

  • Adebrelimab InjectionDrug

    The patient will be treated with Adebrelimab

Study groups in NCT07824882
Study groupRoleWhat they receive
HS-20093 and adebrelimabExperimentalNot described
Receives: Drug: HS-20093 for Injection; Drug: Adebrelimab Injection
HS-20093Active comparatorNot described
Receives: Drug: HS-20093 for Injection

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Objective Response Rate (ORR)

    Objective Response Rate (ORR) assessed by investigator per RECIST v1.1

    Measured: Up to 3 years

  2. Progression-Free Survival (PFS)

    1. Progression-Free Survival (PFS) assessed by investigator per RECIST v1.1

    Measured: Approximately 3 years

Secondary outcomes (4)

  1. duration of response (DoR)

    DoR assessed by investigator per RECIST v1.1

    Measured: Approximately 3 years

  2. 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.

    Measured: Approximately 5 years

  3. Adverse event (AE) and serious adverse event (SAE)

    Incidence and severity of AEs and SAEs

    Measured: 3 years

  4. 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.

    Measured: 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Sep 2026
  2. Study start8 Oct 2026
  3. Primary completion30 Mar 2028 (estimated)
  4. Study completion30 Sep 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
76 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07824882
Sponsor's protocol ID
HS-20093-209
Status last verified
Oct 2026
First submitted
13 Aug 2026
Last updated
23 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing HS-20093 for Injection and Adebrelimab Injection in people with Non-Small Cell Lung Cancer, run by Hansoh BioMedical R&D Company at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 23 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective Response Rate (ORR) (time frame: Up to 3 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07824882.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2026.

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