Limited-stage Small-cell Lung CancerPhase 3NCT06526624
A Study of HS-20093 vs Active Surveillance in Limited-Stage Small Cell Lung Cancer
A Phase 3 study testing HS-20093 in people with Limited-stage Small-cell Lung Cancer, run by Hansoh BioMedical R&D Company.
Trial summary
This study will evaluate the efficacy, safety and tolerability of HS-20093 compared with active surveillance as consolidation therapy after chemoradiotherapy in participants with limited-stage small cell lung cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Limited-stage Small-cell Lung Cancer
- What is being tested?
- HS-20093
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 406 participants
- Where
- No sites listed yet
- Study dates
- 30 Sep 2024to 31 Jan 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
- Have signed Informed Consent Form.
- Males or females ≥18 years old.
- Patients with limited-stage SCLC who are deemed unsuitable for surgery or decline surgery.
- ECOG performance status of 0-1.
- Patients who have received CRT and have not progressed.
- Minimum life expectancy > 12 weeks.
- Males or Females should be using adequate contraceptive measures throughout the study.
- Females must not be pregnant at screening or have evidence of non-childbearing potential.
Who cannot join
- Patients with mixed SCLC or NSCLC or sarcoma-like carcinoma, or large cell neuroendocrine carcinoma.
- Patients with extensive-stage SCLC.
- Disease progression during CRT or before randomization.
- Received or are receiving the following treatments:
- For LS-SCLC, prior treatment with or current use of other chemotherapy regimens other than platinum plus etoposide
- Received any other anti-cancer treatment.
Show all 22Show fewer
- Previous or current treatment with B7-H3 target therapy.
- Traditional Chinese medicine indicated for tumors within 2 weeks prior to the first dose of study drug.
- Major surgery within 4 weeks prior to the first dose of study drug.
- Interstitial lung disease (ILD)/non-infectious pneumonitis.
- History of other primary malignancies.
- Inadequate bone marrow reserve or organ functions.
- Severe, uncontrolled or active cardiovascular disorders.
- Severe or uncontrolled diabetes.
- Serious or poorly controlled hypertension.
- Severe bleeding symptoms or bleeding tendencies within 1 month prior to randomization.
- Severe arteriovenous thrombosis occurred within 3 months prior to randomization.
- Serious infection within 4 weeks prior to randomization.
- Presence of Grade ≥ 2 toxicities due to prior anti-tumor therapy.
- Having serious neurological or mental disorders.
- History of hypersensitivity to any component of HS-200093 or its similar drugs.
- Participants with any condition that compromises the safety of the participant or interferes with the assessment of the study, as judged by the investigator.
About this study
Official title: ARTEMIS-009: A Phase 3, Randomized, Controlled, Multi-center, Open-label Study of HS-20093 Versus Active Surveillance As Consolidation Therapy After Chemoradiotherapy in Subjects With Limited-Stage Small Cell Lung Cancer
This study will evaluate the efficacy, safety and tolerability of HS-20093 compared with active surveillance as consolidation therapy after chemoradiotherapy in participants with limited-stage small cell lung cancer.
Read the detailed description
This is a randomized, controlled, open-label, multi-center, phase III clinical study to evaluate the efficacy and safety of HS-20093 versus active surveillance as consolidation therapy in participants with limited-stage small cell lung cancer (LS-SCLC) who have not progressed after receiving chemoradiotherapy (CRT).
This study consists of an experimental arm and a control arm. The experimental arm will be administered HS-20093, and the control arm will only receive active surveillance. Efficacy and safety were assessed in both arms by follow-up analyses.
- Conditions
- Limited-stage Small-cell Lung Cancer
- Being tested
- HS-20093
- 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
Subjects in experimental arm will be given HS-20093 intravenously at a dose of 8.0 mg/kg every 3 weeks, until disease progression or until other criteria for treatment discontinuation are met.
| Study group | Role | What they receive |
|---|---|---|
| HS-20093 | Experimental | Patients with LS-SCLC who have not progressed following CRT. Patients in this arm will be administrated HS-20093 intravenously at a dose of 8.0 mg/kg, Q3W continuously until disease progression or until other criteria for discontinuation of treatment are met. Receives: Drug: HS-20093 |
| Active surveillance | No intervention | Patients with LS-SCLC who have not progressed following CRT. Patients in this arm will receive active surveillance until disease progression or until other criteria for discontinuation of active surveillance are met. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival (PFS) According to RECIST v1.1 by Independent Review Committee (IRC)
To assess the efficacy of HS-20093 vs active surveillance in terms of PFS. PFS is defined as the time from randomization until the date of objective disease progression or death, whichever occurred first, based on IRC using RECIST v1.1.
Measured: Approximately 6 years
Overall survival (OS)
To assess the efficacy of HS-20093 vs active surveillance in terms of 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 6 years
Secondary outcomes (11)
PFS at 12 Months (PFS12) or 18 Months (PFS18) According to RECIST v1.1 by IRC
PFS12 and PFS18 are defined as the progression-free survival at 12 months and 18 months from the date of randomization, respectively, based on IRC using RECIST v1.1.
Measured: Approximately 6 years.
ORR According to RECIST v1.1 by IRC
ORR is defined as the percentage of participants with BOR of CR or PR per RECIST v1.1
Measured: From the date of randomization until the date of disease progression or withdrawal from study, up to approximately 6 years.
DCR According to RECIST v1.1 by IRC
DCR is defined as the percentage of patients who have a best overall response (confirmed CR, PR, or stable disease)
Measured: From the date of randomization until the date of disease progression or withdrawal from study, approximately 6 years.
DoR by IRC
DoR only applies to participants whose best overall response is CR or PR. The start date is the date of first documented response of CR or PR, and the end date is defined as the date of the first documented progression or death due to underlying disease.
Measured: From the date of CR, PR until the date of disease progression or death, approximately 6 years.
PFS According to RECIST v1.1 by investigators (INVs)
PFS is defined as the time from randomization until the date of objective disease progression or death, whichever occurred first, based on INVs using RECIST v1.1
Measured: Approximately 6 years.
PFS12 or PFS18 According to RECIST v1.1 by INVs
PFS12 and PFS18 are defined as the progression-free survival at 12 months and 18 months from the date of randomization, respectively, based on INVs using RECIST v1.1.
Measured: Approximately 6 years.
ORR According to RECIST v1.1 by INVs
ORR is defined as the percentage of participants with BOR of CR or PR per RECIST v1.1 by INVs.
Measured: From the randomization until the date of disease progression or withdrawal from study, up to approximately 6 years.
DCR According to RECIST v1.1 by INVs
DCR is defined as the percentage of patients who have a best overall response (CR, PR, or stable disease).
Measured: From the randomization until the date of disease progression or withdrawal from study, up to approximately 6 years.
DoR According to RECIST v1.1 by INVs
DoR is defined as the percentage of patients who have a best overall response (CR, PR, or stable disease).
Measured: From the date of first dose until the date of disease progression or withdrawal from study, up to approximately 6 years.
Proportion of patients alive at 24 months (OS24) or 36 months (OS36)
OS24 and OS36 are defined as the proportion of patients alive at 24 months and 36 months from the date of randomization, respectively, based on INVs using RECIST v1.1.
Measured: Approximately 6 years.
Incidence and severity of treatment-emergent adverse events
Adverse event (assessed according to NCI CTCAE v5.0) is defined as any untoward medical occurrence in a participant without regard to possibility of causal relationship.
Measured: From the date of first dose until 90 days after the final dose. A cycle is 21 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2024
- Study start30 Sep 2024 (estimated)
- Primary completion30 Nov 2027 (estimated)
- Study completion31 Jan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Limited-stage 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
- 406 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
- NCT06526624
- Sponsor's protocol ID
- HS-20093-302
- Status last verified
- Jul 2024
- First submitted
- 25 Jul 2024
- Last updated
- 30 Jul 2024
- 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 30 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ARTEMIS-009: A Phase 3, Randomized, Controlled, Multi-center, Open-label Study of HS-20093 Versus Active Surveillance As Consolidation Therapy After Chemoradiotherapy in Subjects With Limited-Stage Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT06526624
- Acronym / sponsor ID
- HS-20093-302
- Conditions
- Limited-stage Small-cell Lung Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 406 participants (estimated)
- Lead sponsor
- Hansoh BioMedical R&D CompanyIndustry (pharma, biotech, devices)
- Study start
- 30 Sep 2024 (estimated)
- Primary completion
- 30 Nov 2027 (estimated)
- Study completion
- 31 Jan 2029 (estimated)
- First posted
- 30 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.
This study will evaluate the efficacy, safety and tolerability of HS-20093 compared with active surveillance as consolidation therapy after chemoradiotherapy in participants with limited-stage small cell lung cancer.
Detailed description
This is a randomized, controlled, open-label, multi-center, phase III clinical study to evaluate the efficacy and safety of HS-20093 versus active surveillance as consolidation therapy in participants with limited-stage small cell lung cancer (LS-SCLC) who have not progressed after receiving chemoradiotherapy (CRT).
This study consists of an experimental arm and a control arm. The experimental arm will be administered HS-20093, and the control arm will only receive active surveillance. Efficacy and safety were assessed in both arms by follow-up analyses.
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-20093Patients with LS-SCLC who have not progressed following CRT. Patients in this arm will be administrated HS-20093 intravenously at a dose of 8.0 mg/kg, Q3W continuously until disease progression or until other criteria for discontinuation of treatment are met. |
| Active surveillance | No intervention | –Patients with LS-SCLC who have not progressed following CRT. Patients in this arm will receive active surveillance until disease progression or until other criteria for discontinuation of active surveillance are met. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Have signed Informed Consent Form.
- Males or females ≥18 years old.
- Patients with limited-stage SCLC who are deemed unsuitable for surgery or decline surgery.
- ECOG performance status of 0-1.
- Patients who have received CRT and have not progressed.
Key exclusion criteria (22 listed)
- Patients with mixed SCLC or NSCLC or sarcoma-like carcinoma, or large cell neuroendocrine carcinoma.
- Patients with extensive-stage SCLC.
- Disease progression during CRT or before randomization.
- Received or are receiving the following treatments:
- Interstitial lung disease (ILD)/non-infectious pneumonitis.
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-20093Subjects in experimental arm will be given HS-20093 intravenously at a dose of 8.0 mg/kg every 3 weeks, until disease progression or until other criteria for treatment discontinuation are met. | Drug | HS-20093 |
Primary outcome
Progression-free survival (PFS) According to RECIST v1.1 by Independent Review Committee (IRC)
Time frame: Approximately 6 years
To assess the efficacy of HS-20093 vs active surveillance in terms of PFS. PFS is defined as the time from randomization until the date of objective disease progression or death, whichever occurred first, based on IRC using RECIST v1.1.
Overall survival (OS)
Time frame: Approximately 6 years
To assess the efficacy of HS-20093 vs active surveillance in terms of OS. Overall Survival is defined as the time from the date of randomization to the date of participant's death due to any cause.
11 secondary outcomes
PFS at 12 Months (PFS12) or 18 Months (PFS18) According to RECIST v1.1 by IRC
Time frame: Approximately 6 years.
ORR According to RECIST v1.1 by IRC
Time frame: From the date of randomization until the date of disease progression or withdrawal from study, up to approximately 6 years.
DCR According to RECIST v1.1 by IRC
Time frame: From the date of randomization until the date of disease progression or withdrawal from study, approximately 6 years.
DoR by IRC
Time frame: From the date of CR, PR until the date of disease progression or death, approximately 6 years.
PFS According to RECIST v1.1 by investigators (INVs)
Time frame: Approximately 6 years.
PFS12 or PFS18 According to RECIST v1.1 by INVs
Time frame: Approximately 6 years.
ORR According to RECIST v1.1 by INVs
Time frame: From the randomization until the date of disease progression or withdrawal from study, up to approximately 6 years.
DCR According to RECIST v1.1 by INVs
Time frame: From the randomization until the date of disease progression or withdrawal from study, up to approximately 6 years.
DoR According to RECIST v1.1 by INVs
Time frame: From the date of first dose until the date of disease progression or withdrawal from study, up to approximately 6 years.
Proportion of patients alive at 24 months (OS24) or 36 months (OS36)
Time frame: Approximately 6 years.
Incidence and severity of treatment-emergent adverse events
Time frame: From the date of first dose until 90 days after the final dose. A cycle is 21 days.
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 30 Jul 2024.
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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 in people with Limited-stage 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 8 inclusion and 22 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 30 Jul 2024. 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) According to RECIST v1.1 by Independent Review Committee (IRC) (time frame: Approximately 6 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?
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 30 Jul 2024.