NCT06498479 ARTEMIS-008：HS-20093 Compared With Topotecan in Subjects With Relapsed Small Cell Lung Cancer
| NCT ID | NCT06498479 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Hansoh BioMedical R&D Company |
| Condition | Small Cell Lung Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 460 participants |
| Start Date | 2024-07-04 |
| Primary Completion | 2026-09-30 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 460 participants in total. It began in 2024-07-04 with a primary completion date of 2026-09-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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).
Eligibility Criteria
Inclusion Criteria: 1. Male or female subjects ≥18 years of age. 2. Histologically or cytologically confirmed SCLC. 3. Subjects who progressed on or after first-line platinum-based regimens. 4. Has at least 1 measurable lesion as defined per RECIST 1.1. 5. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1. 6. Minimum life expectancy of more than 12 weeks. 7. Females subjects must not be pregnant at screening or have evidence of non-childbearing potential. 8. Men or women should be using adequate contraceptive measures throughout the study. 9. Subject has provided informed consent/assent prior to initiation of any study specific activities/procedures. Exclusion Criteria: 1. Combined SCLC, any previous diagnosis of transformed SCLC or SCLC that has transformed to NSCLC. 2. Chemotherapy-free interval ≤30 days. 3. Has received prior treatment with anti-B7 homologue 3 (B7-H3) targeted agents. 4. Has received prior treatment with topoisomerase I inhibitor, including ADC that consists of topoisomerase I inhibitor. 5. Has inadequate washout period before randomization as specified in the protocol. 6. Untreated or symptomatic brain metastases with exceptions defined in the protocol. 7. 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. 8. History of other malignancy with exceptions defined in the protocol. 9. Inadequate bone marrow reserve or organ dysfunction. 10. Evidence of cardiovascular risks. 11. Severe, uncontrolled or active cardiovascular diseases. 12. Severe or uncontrolled diabetes. 13. Severe or uncontrolled high blood pressure. 14. Clinically significant bleeding or obvious bleeding tendency within 1 month before randomization. 15. Severe arterial or venous thromboembolic events within 3 months prior to randomization. 16. Severe infections within 4 weeks before randomization. 17. Receiving systemic corticosteroid therapy within 30 days prior to randomization with exceptions defined in the protocol. 18. The presence of active infectious diseases before randomization. 19. Current hepatic encephalopathy, hepatorenal syndrome, or Child-Pugh Grade B or more severe cirrhosis. 20. History of interstitial lung disease, immunotherapy-induced pneumonitis, clinically moderate or severe pulmonary disease. 21. History of severe neuropathy or mental disorders. 22. 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. 23. Vaccination or hypersensitivity of any level within 4 weeks before randomization. 24. History of severe hypersensitivity reaction, severe infusion reaction or allergy to recombinant human or mouse derived proteins. 25. Hypersensitivity to any ingredient of HS-20093, DNA topoisomerase I inhibitor or regimens of Topotecan.
Frequently Asked Questions
Who can join the NCT06498479 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Small Cell Lung Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06498479 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 460 participants.
Is NCT06498479 currently recruiting?
Yes, NCT06498479 is actively recruiting participants. Visit ClinicalTrials.gov or contact Hansoh BioMedical R&D Company to inquire about joining.
Where is the NCT06498479 trial being conducted?
This trial is being conducted at Beijing, China, Harbin, China, Zhengzhou, China, Changchun, China and 5 additional locations.
Who is sponsoring the NCT06498479 clinical trial?
NCT06498479 is sponsored by Hansoh BioMedical R&D Company. The trial plans to enroll 460 participants.
Related Trials
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.