Small Cell Lung CancerPhase 3NCT06498479
ARTEMIS-008：HS-20093 Compared With Topotecan in Subjects With Relapsed Small Cell Lung Cancer
A Phase 3 study testing HS-20093 and Topotecan in people with Small Cell Lung Cancer, run by Hansoh BioMedical R&D Company at 9 sites in China.
Trial summary
The main objective of this study is to compare the efficacy of HS-20093 with standard of care (SOC) on prolonging overall survival (OS) in subjects with relapsed small cell lung cancer (SCLC). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Small Cell Lung Cancer
- What is being tested?
- HS-20093 and Topotecan
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 461 participants
- Where
- 9 sitesChina
- Study dates
- 4 Jul 2024to 20 Aug 2026
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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
- Male or female subjects ≥18 years of age.
- Histologically or cytologically confirmed SCLC.
- Subjects who progressed on or after first-line platinum-based regimens.
- Has at least 1 measurable lesion as defined per RECIST 1.1.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
- Minimum life expectancy of more than 12 weeks.
Show all 9Show fewer
- Females subjects must not be pregnant at screening or have evidence of non-childbearing potential.
- Men or women should be using adequate contraceptive measures throughout the study.
- Subject has provided informed consent/assent prior to initiation of any study specific activities/procedures.
Who cannot join
- Combined SCLC, any previous diagnosis of transformed SCLC or SCLC that has transformed to NSCLC.
- Chemotherapy-free interval ≤30 days.
- Has received prior treatment with anti-B7 homologue 3 (B7-H3) targeted agents.
- Has received prior treatment with topoisomerase I inhibitor, including ADC that consists of topoisomerase I inhibitor.
- Has inadequate washout period before randomization as specified in the protocol.
- Untreated or symptomatic brain metastases with exceptions defined in the protocol.
Show all 25Show fewer
- Unresolved toxicity from prior anti-tumor therapy, defined as not having resolved to Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 grade 1 with exceptions defined in the protocol.
- History of other malignancy with exceptions defined in the protocol.
- Inadequate bone marrow reserve or organ dysfunction.
- Evidence of cardiovascular risks.
- Severe, uncontrolled or active cardiovascular diseases.
- Severe or uncontrolled diabetes.
- Severe or uncontrolled high blood pressure.
- Clinically significant bleeding or obvious bleeding tendency within 1 month before randomization.
- Severe arterial or venous thromboembolic events within 3 months prior to randomization.
- Severe infections within 4 weeks before randomization.
- Receiving systemic corticosteroid therapy within 30 days prior to randomization with exceptions defined in the protocol.
- The presence of active infectious diseases before randomization.
- Current hepatic encephalopathy, hepatorenal syndrome, or Child-Pugh Grade B or more severe cirrhosis.
- History of interstitial lung disease, immunotherapy-induced pneumonitis, clinically moderate or severe pulmonary disease.
- History of severe neuropathy or mental disorders.
- Female subjects of childbearing potential; female subjects who are breastfeeding or who plan to breastfeed while on study; female subjects planning to become pregnant while on study.
- Vaccination or hypersensitivity of any level within 4 weeks before randomization.
- History of severe hypersensitivity reaction, severe infusion reaction or allergy to recombinant human or mouse derived proteins.
- Hypersensitivity to any ingredient of HS-20093, DNA topoisomerase I inhibitor or regimens of Topotecan.
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
China9 sites
Beijing Cancer Hospital
Beijing, Beijing Municipality
Jilin Cancer Hospital
Changchun, Jilin
The First Affiliate Hospital of GUANGZHOU Medical University
Guangzhou
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang
Shandong Cancer Hospital
Jinan, Shandong
Shanghai Pulmonary Hospital
Shanghai, Shanghai Municipality
Shengjing Hospital of China Medical University
Shenyang, Liaoning
Tongji Hospital
Wuhan
Henan Cancer Hospital
Zhengzhou, Henan
About this study
Official title: ARTEMIS-008：A Multicenter, Randomized, Open-label, Phase 3 Study of HS-20093 Compared With Topotecan in Subjects With Relapsed Small Cell Lung Cancer After Platinum-based First-line Chemotherapy
The main objective of this study is to compare the efficacy of HS-20093 with standard of care (SOC) on prolonging overall survival (OS) in subjects with relapsed small cell lung cancer (SCLC).
Read the detailed description
This is a phase 3, randomized, open-label, multicenter study comparing HS-20093 with topotecan in patients with limited or extensive SCLC that had disease progression on or after first-line platinum-based regimen. Subjects will be randomized by a ratio of 1:1 to receive HS-20093 or topotecan until disease progression.
The primary objective of this study is to assess whether treatment with HS-20093 prolongs OS compared with treatment of topotecan among subjects with relapsed SCLC.
The secondary objectives of the study are to further evaluate the efficacy/safety of HS-20093. The exploratory objectives are to characterize the pharmacokinetics of HS-20093, evaluate E-R relationship, immunogenicity of HS-20093, B7-H3 protein expression and soluble B7-H3 expression.
- Conditions
- Small Cell Lung Cancer
- Being tested
- HS-20093, Topotecan
- Medical subject headings
- Small Cell Lung Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HS-20093Drug
HS-20093 will be administered as an IV infusion at dose of 8.0 mg/kg on Day 1 of each 21-day cycle.
TopotecanDrug
Topotecan will be administered per drug label.
| Study group | Role | What they receive |
|---|---|---|
| HS-20093 | Experimental | Participants will receive HS-20093 as an intravenous (IV) infusion at dose of 8.0 mg/kg on Day 1 of each 21-day cycle until a treatment discontinuation criterion is met as specified in the protocol. Receives: Drug: HS-20093 |
| Topotecan | Active comparator | Participants will receive topotecan until a treatment discontinuation criterion is met as specified in the protocol. Receives: Drug: Topotecan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
Overall survival is defined as the time interval from randomization to death due to any cause.
Measured: From the date of randomization to the date of death due to any cause; Up to approximately 4.5 years
Secondary outcomes (5)
Objective Response Rate (ORR) Assessed by Blinded Independent Central Review and Investigators
Confirmed ORR is defined as the sum of the complete response (CR) rate and partial response (PR) rate as per BICR and investigator per Response Evaluation Criteria In Solid Tumors (RECIST) v1.1.
Measured: From the date of randomization to documented progressive disease, death, lost to follow-up, or withdrawal by the participant; Up to approximately 4.5 years.
Disease Control Rate (DCR) Assessed by Blinded Independent Central Review and Investigator
Disease control rate is defined as the proportion of participants who have achieved a best overall response of confirmed CR, confirmed PR, or SD (or non-CR/non-PD) per BICR and investigator assessment per RECIST v1.1.
Measured: From the date of randomization to documented progressive disease, death, lost to follow-up, or withdrawal by the participant; Up to approximately 4.5 years.
Duration of Response Assessed by Blinded Independent Central Review and Investigator
Duration of response (DoR) is defined as the time from the date of the first documentation of objective response (complete response [CR] or partial response [PR]) to the date of the first documentation of progressive disease (PD) or death.
Measured: From the date of first documentation of confirmed response (CR or PR) to the first documentation of objective progression or to death due to any cause, whichever occurs first; Up to approximately 4.5 years.
Progression-free Survival Assessed by Blinded Independent Central Review and Investigator
PFS is defined as the time interval from the randomization to disease progression as per BICR and investigator assessment or death due to any cause.
Measured: From the date of randomization to documented progressive disease, death, lost to follow-up, or withdrawal by the participant; Up to approximately 4.5 years.
Incidence and Grade of Participants With Treatment-emergent Adverse Events
TEAEs are assessed based on NCI CTCAE v5.0.
Measured: From the date of first dose to the end of safety follow-up; Up to approximately 4.5 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2024
- Study start4 Jul 2024
- Primary completion20 Aug 2026
- Study completion20 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- 461 participants (actual)
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
- NCT06498479
- Sponsor's protocol ID
- HS-20093-301
- Status last verified
- May 2026
- First submitted
- 6 Jul 2024
- Last updated
- 16 Oct 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ARTEMIS-008：A Multicenter, Randomized, Open-label, Phase 3 Study of HS-20093 Compared With Topotecan in Subjects With Relapsed Small Cell Lung Cancer After Platinum-based First-line Chemotherapy
- ClinicalTrials.gov ID
- NCT06498479
- Acronym / sponsor ID
- HS-20093-301
- Conditions
- Small Cell Lung Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 461 participants (actual)
- Lead sponsor
- Hansoh BioMedical R&D CompanyIndustry (pharma, biotech, devices)
- Study start
- 4 Jul 2024 (actual)
- Primary completion
- 20 Aug 2026 (actual)
- Study completion
- 20 Aug 2026 (actual)
- First posted
- 12 Jul 2024 (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.
The main objective of this study is to compare the efficacy of HS-20093 with standard of care (SOC) on prolonging overall survival (OS) in subjects with relapsed small cell lung cancer (SCLC).
Detailed description
This is a phase 3, randomized, open-label, multicenter study comparing HS-20093 with topotecan in patients with limited or extensive SCLC that had disease progression on or after first-line platinum-based regimen. Subjects will be randomized by a ratio of 1:1 to receive HS-20093 or topotecan until disease progression.
The primary objective of this study is to assess whether treatment with HS-20093 prolongs OS compared with treatment of topotecan among subjects with relapsed SCLC.
The secondary objectives of the study are to further evaluate the efficacy/safety of HS-20093. The exploratory objectives are to characterize the pharmacokinetics of HS-20093, evaluate E-R relationship, immunogenicity of HS-20093, B7-H3 protein expression and soluble B7-H3 expression.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HS-20093 | Experimental | Drug: HS-20093Participants will receive HS-20093 as an intravenous (IV) infusion at dose of 8.0 mg/kg on Day 1 of each 21-day cycle until a treatment discontinuation criterion is met as specified in the protocol. |
| Topotecan | Active comparator | Drug: TopotecanParticipants will receive topotecan until a treatment discontinuation criterion is met as specified in the protocol. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Male or female subjects ≥18 years of age.
- Histologically or cytologically confirmed SCLC.
- Subjects who progressed on or after first-line platinum-based regimens.
- Has at least 1 measurable lesion as defined per RECIST 1.1.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
Key exclusion criteria (25 listed)
- Combined SCLC, any previous diagnosis of transformed SCLC or SCLC that has transformed to NSCLC.
- Chemotherapy-free interval ≤30 days.
- Has received prior treatment with anti-B7 homologue 3 (B7-H3) targeted agents.
- Has received prior treatment with topoisomerase I inhibitor, including ADC that consists of topoisomerase I inhibitor.
- Has inadequate washout period before randomization as specified in the protocol.
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-20093HS-20093 will be administered as an IV infusion at dose of 8.0 mg/kg on Day 1 of each 21-day cycle. | Drug | HS-20093 |
| TopotecanTopotecan will be administered per drug label. | Drug | Topotecan |
Primary outcome
Overall survival
Time frame: From the date of randomization to the date of death due to any cause; Up to approximately 4.5 years
Overall survival is defined as the time interval from randomization to death due to any cause.
5 secondary outcomes
Objective Response Rate (ORR) Assessed by Blinded Independent Central Review and Investigators
Time frame: From the date of randomization to documented progressive disease, death, lost to follow-up, or withdrawal by the participant; Up to approximately 4.5 years.
Disease Control Rate (DCR) Assessed by Blinded Independent Central Review and Investigator
Time frame: From the date of randomization to documented progressive disease, death, lost to follow-up, or withdrawal by the participant; Up to approximately 4.5 years.
Duration of Response Assessed by Blinded Independent Central Review and Investigator
Time frame: From the date of first documentation of confirmed response (CR or PR) to the first documentation of objective progression or to death due to any cause, whichever occurs first; Up to approximately 4.5 years.
Progression-free Survival Assessed by Blinded Independent Central Review and Investigator
Time frame: From the date of randomization to documented progressive disease, death, lost to follow-up, or withdrawal by the participant; Up to approximately 4.5 years.
Incidence and Grade of Participants With Treatment-emergent Adverse Events
Time frame: From the date of first dose to the end of safety follow-up; Up to approximately 4.5 years.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2026.
Related trials for Small Cell Lung Cancer
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
A Prospective ,Multicenter ,Non-interventional ,Real-world Study Observing Changes in Molecular Markers Osimertinib Targeted Therapy in EGFRm NSCLC
Non Small Cell Lung Cancer
RecruitingPhase 3
A Study Evaluating Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Participants With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers (CodeBreaK 202)
Non-Small Cell Lung Cancer (NSCLC)
RecruitingPhase 2
A UGT1A1 Genotype-Directed Study of Belinostat Pharmacokinetics and Toxicity
Carcinoma, Neuroendocrine, Tumor, Neuroendocrine
Active, not recruitingPhase 2
Datopotamab Deruxtecan (Dato-DXd, DS-1062a) in Advanced and/or Unresectable Non-Small Cell Lung Cancer
Metastatic Lung Cancer, Advanced Non Small Cell Lung Cancer
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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing HS-20093 and Topotecan in people with Small Cell Lung Cancer, run by Hansoh BioMedical R&D Company at 9 sites 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 25 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: finished, as of the sponsor's last update on 16 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 9 sites 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 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Overall survival (time frame: From the date of randomization to the date of death due to any cause; Up to approximately 4.5 years). 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 16 Oct 2026.