ClinicalTrials.gg
RecruitingNCT07824882Updated Oct 23, 2026

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 interventional study of HS-20093 for Injection and Adebrelimab Injection in Non-Small Cell Lung Cancer, sponsored by Hansoh BioMedical R&D Company. Recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-23.

Sponsored by Hansoh BioMedical R&D Company (part of Hansoh Pharmaceutical Group Company Limited) · Phase 2, Interventional, and Treatment

From the registry’s dates

  • Started Oct 2026; still recruiting 1 month later.
Updated Oct 23, 2026Now RecruitingFirst site in China+2 moreGo to Updates ↓
Phase
Phase 2
Study type
Interventional
Enrollment
76
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 16 studies testing adebrelimab in Carcinoma, Non-Small-Cell Lung — 16 open to participants now, 16 under way, 3 of them phase 3. adebrelimab · Carcinoma, Non-Small-Cell Lung.

Planned enrollment
10th of 16
76 · median 85
Started
2026
with 7 others
Phase 2
12 of 16
12 open now
Primary completion
2028-03
later than 7 of 15 live
Registered
11th of 16
by date
Lead sponsor
1 of 16
Hansoh BioMedical R&D Company

Among the 16 studies testing adebrelimab in Carcinoma, Non-Small-Cell Lung, this one is the 10th largest by planned enrollment, is one of 8 that started in 2026, is one of 12 in phase 2, reaches primary completion later than 7 of the 15 other live ones, and was the 11th registered.

By phase

16 studies; the count open now beside each. This study's row is marked.

Phase 2this study12 · 12 open
Phase 32 · 2 open
Phase 1/21 · 1 open
Phase 2/31 · 1 open

By the year they started

First in 2022; this study’s year is marked. 8 started in 2026.

Size and results

Median enrollment 85 across the 16 interventional studies. None of them has completed or been terminated yet.

Watch this landscapeDownload CSVWith an account: a weekly mail of what changed among 16 studies testing adebrelimab in Carcinoma, Non-Small-Cell Lung, or all of them as a file.
02

Study 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 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.

03

Conditions studied

  • Non-Small Cell Lung Cancer

Keywords

  • Non-Small Cell Lung Cancer
  • HS-20093
  • B7H3
  • Antibody-Drug Conjugates
  • PD-L1 inhibitor
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Age ≥18 years at the time of 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 or cytologically confirmed diagnosis of advanced or non-squamous non-small cell lung cancer (nsq-NSCLC).
  4. Presence of at least one measurable target lesion.
  5. performance status (ECOG PS) score of 0 to 1.
  6. Minimum >12 weeks.
  7. Adequate organ function.
  8. Absence of the following active infectious diseases: , , (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

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 ; uncontrolled brain metastases; presence of or brainstem ; presence of spinal cord compression (identified by radiographic imaging, regardless of symptoms).
  5. History of other primary .
  6. Presence of any of the following abnormal cardiac findings:

    1. Evidence of currently important arrhythmia or abnormality;
    2. Presence of risk factors causing 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 disease with potential for recurrence.
  15. Prior occurrence of severe or life-threatening immune-mediated adverse events.
Terms in these criteria, in plain language(15)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Histologically or cytologically confirmed

The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).

Your pathology report is the document that shows this.

Metastases

Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.

ECOG performance status

A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.

0
Fully active, no restrictions.
1
Limited in strenuous activity, but walking and able to do light work, such as housework or office work.
2
Walking and able to look after yourself, but unable to work; up and about more than half of waking hours.
3
Able to look after yourself only in part; in bed or a chair more than half of waking hours.
4
Unable to look after yourself at all; in bed or a chair all day.

Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.

Life expectancy

The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.

Hepatitis B tests

Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.

Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.

Hepatitis C tests

Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.

After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

Brain metastases

Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).

Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.

Leptomeningeal disease

Cancer that has spread to the leptomeninges, the thin layers covering the brain and spinal cord, and the fluid between them. It is not the same as brain metastases.

Criteria often treat it separately, and many studies leave it out even where treated brain metastases are allowed.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

ECG (electrocardiogram)

A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.

QT and QTc

On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.

The study may name a correction formula and a limit in milliseconds, often around 450–480.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
76 participants (estimated)

Study arms

  • Experimental
    HS-20093 and adebrelimab

    Drug: HS-20093 for Injection · Drug: Adebrelimab Injection

  • Active comparator
    HS-20093

    Drug: HS-20093 for Injection

Interventions

06

What researchers measure

Primary outcomes

  1. Objective Response Rate (ORR)

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

    Time frame: Up to 3 years

  2. Progression-Free Survival (PFS)

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

    Time frame: Approximately 3 years

Secondary outcomes

  1. duration of response (DoR)

    DoR assessed by investigator per RECIST v1.1

    Time frame: 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.

    Time frame: Approximately 5 years

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

    Incidence and severity of AEs and SAEs

    Time frame: 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.

    Time frame: 3 years

07

Study locations

1 of 1 sites recruiting
08

Updates

2 registry updates since Sep 25, 2026
Status
Not yet recruiting→Recruiting
changed Oct 23, 2026
Sites
1 site added — first site in China
Show site
  • Tongji Hospital, Affiliated to Tongji Medical College of Huazhong University of Science and Technology · Wuhan, China
Oct 23, 2026
Start date
Sep 10, 2026→Oct 8, 2026 (actual)
moved 2 times, Oct 21, 2026 – Oct 23, 2026
Show all 2 updates
  1. Oct 23, 2026
    Not yet recruiting→Recruiting
    1 site added — first site in China
    Show site
    • Tongji Hospital, Affiliated to Tongji Medical College of Huazhong University of Science and Technology · Wuhan, China
    Start date Oct 30, 2026→Oct 8, 2026 (now actual)
  2. Oct 21, 2026
    Start date Sep 10, 2026→Oct 30, 2026
    + 1 other change: verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

09

Registry details

Key details

Study ID
NCT07824882
Responsible party
Sponsor
First posted
Sep 17, 2026
Start date
Oct 8, 2026
Primary completion
Mar 30, 2028 (estimated)
Completion
Sep 30, 2029 (estimated)
Last update
Oct 23, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

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No contact was published for this record. The registry link below has the sponsor’s details.

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