ARTEMIS-008：HS-20093 Compared With Topotecan in Subjects With Relapsed Small Cell Lung Cancer

Launched by HANSOH BIOMEDICAL R&D COMPANY · Jul 6, 2024

Keywords

ClinConnect Summary

The ARTEMIS-008 clinical trial is studying a new treatment called HS-20093 to see how well it works compared to the standard medication, Topotecan, for people with relapsed small cell lung cancer (SCLC). This trial aims to find out if HS-20093 can help patients live longer after their cancer has come back following initial treatment. The trial is currently recruiting participants aged 18 and older who have been diagnosed with SCLC and have shown progression after receiving first-line chemotherapy.

To be eligible for the trial, participants must have a measurable cancer lesion and a good performance status, meaning they can carry out daily activities. They should also expect to live for at least 12 weeks. Women of childbearing age need to be non-pregnant and take contraceptive measures. During the trial, participants will receive either HS-20093 or Topotecan, and they will be closely monitored for their health and any side effects. This study is an important step in finding new treatment options for patients with relapsed SCLC, so if you or a loved one are considering participation, it could be a valuable opportunity.

Gender

ALL

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.