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Compares treatment options for Small Cell Lung Cancer
Official title ARTEMIS-008：HS-20093 Compared With Topotecan in Subjects With Relapsed Small Cell Lung Cancer
ClinicalTrials.gov ID: NCT06498479
What this study is testing
What is HS-20093?
HS-20093 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for small cell lung cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Male or female people ≥18 years of age.
- Histologically or cytologically confirmed SCLC.
- people 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.
You likely can't join if
- 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.
See the full eligibility criteria
- Male or female people ≥18 years of age.
- Histologically or cytologically confirmed SCLC.
- people 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.
- Females people 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.
- 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.
- 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 people of childbearing potential; female people who are breastfeeding or who plan to breastfeed while on study; female people 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.
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, Beijing Municipality, China
- Harbin, Heilongjiang, China
- Zhengzhou, Henan, China
- Changchun, Jilin, China
- Shenyang, Liaoning, China
- Jinan, Shandong, China
- Shanghai, Shanghai Municipality, China
- Guangzhou, China
- Wuhan, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, Beijing Municipality, China; Harbin, Heilongjiang, China; Zhengzhou, Henan, China; Changchun, Jilin, China; Shenyang, Liaoning, China; Jinan, Shandong, China and 3 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.