Non-Small Cell Lung CancerPhase 3NCT07464327
A Phase III Study of HS-20093 Injection Combined With Adebrelimab Versus Docetaxel in Previously Treated Patients With Advanced or Metastatic Non-Squamous Non-Small Cell Lung Cancer Without Actionable Genomic Alterations
A Phase 3 study testing HS-20093 and Docetaxel in people with Non-Small Cell Lung Cancer, run by Hansoh BioMedical R&D Company.
Trial summary
This is a multicenter, randomized, open-label, controlled phase III clinical study to evaluate the efficacy and safety of HS-20093 injection combined with adebrelimab versus docetaxel 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 and Docetaxel
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 450 participants
- Where
- No sites listed yet
- Study dates
- 31 Mar 2026to 31 Dec 2029
- Phase
- Phase 3
- 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.
About this study
Official title: A Multicenter, Randomized, Open-Label, Controlled Phase III Clinical Study Evaluating the Efficacy and Safety of HS-20093 Injection Combined With Adebrelimab Versus Docetaxel 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 III clinical study to evaluate the efficacy and safety of HS-20093 injection combined with adebrelimab versus docetaxel 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 III clinical study to evaluate the efficacy and safety of HS-20093 injection combined with adebrelimab versus docetaxel 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 (docetaxel injection). Participants in the experimental arm will receive intravenous infusions of HS-20093 and adebrelimab: HS-20093 at a dose of 8.0 mg/kg every 3 weeks (Q3W) until disease progression or other treatment discontinuation criteria are met; adebrelimab at a dose of 1200 mg Q3W until disease progression or other treatment discontinuation criteria are met. Participants in the control arm will receive docetaxel at a dose of 75 mg/m² Q3W 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, Docetaxel
- 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-20093Drug
Also called Risvutatug Rezetecan, GSK5764227
Participants will receive intravenous infusions of HS-20093 and adebrelimab: HS-20093 at a dose of 8.0 mg/kg every 3 weeks (Q3W) until disease progression or other treatment discontinuation criteria are met; adebrelimab at a dose of 1200 mg Q3W until disease progression or other treatment discontinuation criteria are met.
DocetaxelDrug
Participants will receive docetaxel at a dose of 75 mg/m² Q3W until disease progression or other treatment discontinuation criteria are met.
| Study group | Role | What they receive |
|---|---|---|
| HS-20093 and adebrelimab | Experimental | Not described Receives: Drug: HS-20093 |
| Docetaxel | Active comparator | Not described Receives: Drug: Docetaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival (PFS) assessed by Blinded Independent Central Review (BICR)
Progression-free survival (PFS) assessed by BICR per RECIST v1.1.
Measured: Approximately 3 years after the fist patient with first dose
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 after the fist patient with first dose
Secondary outcomes (6)
PFS assessed by investigator
PFS assessed by investigator per RECIST v1.1
Measured: Approximately 3 years after the fist patient with first dose
Objective response rate (ORR)
Objective response rate (ORR) assessed by BICR and investigator per RECIST v1.1
Measured: Approximately 3 years after the fist patient with first dose
Disease control rate (DCR)
Disease control rate (DCR) assessed by BICR and investigator per RECIST v1.1
Measured: Approximately 3 years after the fist patient with first dose
Duration of response (DoR)
Duration of response (DoR) assessed by BICR and investigator per RECIST v1.1
Measured: Approximately 3 years after the fist patient with first dose
Incidence and severity of AEs
Measured: From the first dose until 90 days after the last dose
Incidence and severity of SAEs
Measured: From the first dose until 90 days after the last dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2026
- Study start31 Mar 2026 (estimated)
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 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.
- More trials run by Hansoh BioMedical R&D CompanyThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 450 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
- NCT07464327
- Sponsor's protocol ID
- HS-20093-309
- Status last verified
- Mar 2026
- First submitted
- 6 Mar 2026
- Last updated
- 11 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Open-Label, Controlled Phase III Clinical Study Evaluating the Efficacy and Safety of HS-20093 Injection Combined With Adebrelimab Versus Docetaxel in Previously Treated Patients With Advanced or Metastatic Non-Squamous Non-Small Cell Lung Cancer Without Actionable Genomic Alterations
- ClinicalTrials.gov ID
- NCT07464327
- Acronym / sponsor ID
- HS-20093-309
- Conditions
- Non-Small Cell Lung Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 450 participants (estimated)
- Lead sponsor
- Hansoh BioMedical R&D CompanyIndustry (pharma, biotech, devices)
- Study start
- 31 Mar 2026 (estimated)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 11 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a multicenter, randomized, open-label, controlled phase III clinical study to evaluate the efficacy and safety of HS-20093 injection combined with adebrelimab versus docetaxel in previously treated patients with advanced or metastatic non-squamous non-small cell lung cancer without actionable genomic alterations.
Detailed description
This is a multicenter, randomized, open-label, controlled phase III clinical study to evaluate the efficacy and safety of HS-20093 injection combined with adebrelimab versus docetaxel 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 (docetaxel injection). Participants in the experimental arm will receive intravenous infusions of HS-20093 and adebrelimab: HS-20093 at a dose of 8.0 mg/kg every 3 weeks (Q3W) until disease progression or other treatment discontinuation criteria are met; adebrelimab at a dose of 1200 mg Q3W until disease progression or other treatment discontinuation criteria are met. Participants in the control arm will receive docetaxel at a dose of 75 mg/m² Q3W 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HS-20093 and adebrelimab | Experimental | Drug: HS-20093 |
| Docetaxel | Active comparator | Drug: Docetaxel |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (20 listed)
- 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:
- Persistent adverse reactions caused by prior treatment.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HS-20093Also: Risvutatug Rezetecan, GSK5764227Participants will receive intravenous infusions of HS-20093 and adebrelimab: HS-20093 at a dose of 8.0 mg/kg every 3 weeks (Q3W) until disease progression or other treatment discontinuation criteria are met; adebrelimab at a dose of 1200 mg Q3W until disease progression or other treatment discontinuation criteria are met. | Drug | HS-20093 and adebrelimab |
| DocetaxelParticipants will receive docetaxel at a dose of 75 mg/m² Q3W until disease progression or other treatment discontinuation criteria are met. | Drug | Docetaxel |
Primary outcome
Progression-free survival (PFS) assessed by Blinded Independent Central Review (BICR)
Time frame: Approximately 3 years after the fist patient with first dose
Progression-free survival (PFS) assessed by BICR per RECIST v1.1.
Overall survival (OS)
Time frame: Approximately 5 years after the fist patient with first dose
Overall Survival is defined as the time from the date of randomization to the date of participant's death due to any cause.
6 secondary outcomes
PFS assessed by investigator
Time frame: Approximately 3 years after the fist patient with first dose
Objective response rate (ORR)
Time frame: Approximately 3 years after the fist patient with first dose
Disease control rate (DCR)
Time frame: Approximately 3 years after the fist patient with first dose
Duration of response (DoR)
Time frame: Approximately 3 years after the fist patient with first dose
Incidence and severity of AEs
Time frame: From the first dose until 90 days after the last dose
Incidence and severity of SAEs
Time frame: From the first dose until 90 days after the last dose
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing HS-20093 and Docetaxel in people with Non-Small Cell Lung Cancer, run by Hansoh BioMedical R&D Company.
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: opening soon, as of the sponsor's last update on 11 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free survival (PFS) assessed by Blinded Independent Central Review (BICR) (time frame: Approximately 3 years after the fist patient with first dose). 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?
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 11 Mar 2026.