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.
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
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
- 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
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.
- Conditions
- Non-Small Cell Lung Cancer
- 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 group | Role | What they receive |
|---|---|---|
| HS-20093 and adebrelimab | Experimental | Not described Receives: Drug: HS-20093 for Injection; Drug: Adebrelimab Injection |
| HS-20093 | Active comparator | Not described Receives: Drug: HS-20093 for Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate (ORR)
Objective Response Rate (ORR) assessed by investigator per RECIST v1.1
Measured: Up to 3 years
Progression-Free Survival (PFS)
- Progression-Free Survival (PFS) assessed by investigator per RECIST v1.1
Measured: Approximately 3 years
Secondary outcomes (4)
duration of response (DoR)
DoR assessed by investigator per RECIST v1.1
Measured: Approximately 3 years
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
Adverse event (AE) and serious adverse event (SAE)
Incidence and severity of AEs and SAEs
Measured: 3 years
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.
- First posted17 Sep 2026
- Study start8 Oct 2026
- Primary completion30 Mar 2028 (estimated)
- Study completion30 Sep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Small Cell Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Hansoh BioMedical R&D Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
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